Does Chile require post-trial access?

Yes. Article 111 C of the Código Sanitario gives clinical trial participants a right to continued treatment after the trial ends, free of charge, for as long as the treatment retains therapeutic usefulness. The duty falls first on the holder of the ISP special provisional-use authorization and then on the holder of the product's sanitary registration. The same right is restated in Article 17 of Ley 20.850. Breach is sanctionable under Article 111 G through Book Ten of the Código Sanitario.

What is Ley 20.850 (Ley Ricarte Soto)?

Ley 20.850 is the Chilean statute that created a universal financial protection system for high-cost diagnoses and treatments, promulgated 1 June 2015 and published 6 June 2015. Beyond the fund, its Article 34 inserted Titles V and VI into Book Four of the Código Sanitario, creating Chile's clinical trial authorization regime (Arts. 111 A to 111 G) and its defective health-product liability regime (Arts. 111 H to 111 N).

What does Código Sanitario Art. 111 C require?

Once a clinical trial ends, the holder of the special provisional-use authorization — and afterwards, where applicable, the holder of the product's sanitary registration — must provide the participant with continuity of treatment sin costo para el paciente, for the whole time that its therapeutic usefulness persists, in accordance with the study protocol. A second paragraph extends the duty to a registration holder that never held the provisional authorization or acquired the registration later.

Does Chile PTA apply to medical devices?

Yes. Article 111 A states that the special provisional-use authorization is required for todo producto farmacéutico o dispositivo médico, and Title V is titled for pharmaceutical products and elements of medical use. Because Article 111 C attaches to the holder of that authorization, device sponsors are captured. The Ministry of Health may exempt low-risk device categories from the authorization requirement by supreme decree.

Who pays for post-trial supply in Chile?

The obligated party pays. Article 111 C says the treatment is provided sin costo para el paciente and names the provisional-use authorization holder and then the sanitary-registration holder. There is no provision allowing the cost to be shifted to the patient, the treating institution, FONASA or an isapre. Contractual allocation between sponsor, licensee or acquirer does not change who Chilean law holds responsible to the patient.

How long must sponsors provide post-trial access in Chile?

For as long as therapeutic usefulness persists — por todo el tiempo que persista su utilidad terapéutica. Chile sets no fixed term, no five-year cap, and no automatic termination at commercial launch or reimbursement listing. That is materially more open-ended than Brazil, where Lei 14.874/2024 permits interruption five years after commercial availability.

What is the M&A diligence trap in Chile PTA?

The second paragraph of Article 111 C binds the sanitary-registration holder aun cuando no haya sido el titular de la autorización provisional o haya adquirido con posterioridad el registro sanitario. The supply duty travels with the registration by operation of law, so a buyer acquiring only a Chilean marketing authorization can inherit an open-ended, free-of-charge obligation arising from a trial it never ran.

What is ISP's role in Chile PTA?

The Instituto de Salud Pública grants the Article 111 A special provisional-use authorization (maximum one year, renewable), maintains the public register of authorized human research, accredits research centers under Article 111 D, and fiscalizes protocols, informed consents, GCP and adverse-event notification. Its listed fee for prestación 4111035 is CLP $1,129,893 plus IVA.

What is CENABAST and how does its exceptional-import route work?

CENABAST is Chile's Central de Abastecimiento. Under Article 15 of Ley 20.850, where a covered product's registration is suspended, cancelled or lapsed, CENABAST may — with prior Ministry of Health authorization and where no priced alternative exists — exceptionally import and distribute it regardless of registration status to guarantee treatment continuity. Article 31 lets it contract with multiple suppliers and request a provisional sanitary registration in shortage situations.

Does the PTA obligation transfer with the marketing authorization?

Yes. That is the explicit effect of Article 111 C's second paragraph. Acquirers and in-licensees should treat the Chilean registration as carrying a potential supply liability, diligence the ISP research register and the seller's Chilean trial history, quantify the number of patients still on treatment, and negotiate indemnities knowing that the statutory duty to the patient sits with whoever holds the registration.

Does Brazil require post-trial access?

Yes, as a matter of statute. Lei 14.874/2024 Chapter VI (Arts. 30–37) and Decreto 12.651/2025 Article 31 require the sponsor to guarantee free continued supply of the investigational product to participants whenever the responsible investigator considers it the best therapeutic alternative for that participant's clinical condition and the risk-benefit assessment is favorable. Brazil's Ministry of Health describes this as 'não é uma expectativa, mas um dever legal.' The obligation begins before the trial does: Article 30 requires a post-study access plan to be filed with the research ethics committee before enrollment starts.

What is Lei 14.874/2024?

Lei nº 14.874 of 28 May 2024 is Brazil's Marco Legal de Pesquisa Clínica, the statute governing research with human subjects. It created the Sistema Nacional de Ética em Pesquisa com Seres Humanos, split into a national ethics instance and the CEPs, and devoted Chapter VI to continuity of treatment after the clinical trial. It entered into force 90 days after its 29 May 2024 official publication under Article 65.

What is Decreto 12.651/2025?

Decreto nº 12.651 of 7 October 2025 is the implementing decree for Lei 14.874/2024, effective on publication in the Diário Oficial da União of 8 October 2025 under Article 41. Article 31 restates the sponsor's free-supply duty using the broader phrase 'produto sob investigação', requires the sponsor to draft the post-study access program and submit it to the competent CEP with its supply strategy, and reserves detailed guidelines to a future INAEP norm.

Who pays for post-trial supply in Brazil?

The sponsor, exclusively and free of charge to the participant. Lei 14.874/2024 Article 31 §4 provides that supply of the medicine is the sponsor's responsibility; Article 34 §1 requires the sponsor to guarantee free post-trial supply; and Decreto 12.651/2025 Article 31 uses 'fornecimento gratuito'. RDC 38/2013 Article 18 adds that the sponsor must fund complete free treatment, keep the product properly stored, refrain from commercializing it, and fund integral assistance for complications arising from its use.

How long must sponsors provide post-trial access in Brazil?

There is no fixed end date. Lei 14.874/2024 Article 33 allows interruption only on seven grounds, each requiring justification submitted to the CEP: participant decision, cure or a satisfactory alternative, absence of continued benefit, a disqualifying adverse reaction, technical or safety impossibility of manufacture with an equivalent alternative supplied, five years counted from commercial availability in Brazil, or availability in the public health network. Because the five-year clock starts at Brazilian commercial availability rather than trial close, the practical tail is the longest in Latin America.

Does Brazil post-trial access apply to medical devices?

Yes. Article 37 of Lei 14.874/2024 extends the entire post-trial chapter to 'produtos e dispositivos médicos' used in clinical trials, insofar as applicable, and Decreto 12.651/2025 Article 31 speaks of the investigational product rather than the medicine. The operational gap is that ANVISA's RDC 38/2013 assistance-program framework addresses 'medicamento' only, so device sponsors have a clear statutory duty but must build the post-close import and dispensing route from the trial's own authorization documents.

Does Brazil post-trial access apply to advanced therapy medicinal products (ATMPs)?

Yes. Article 37 names 'produtos de terapias avançadas experimentais' alongside devices, so the post-trial chapter applies to cell, gene and tissue-engineered investigational products insofar as applicable. ATMPs have a dedicated ANVISA service channel for compassionate use, expanded access and post-study supply of advanced therapy products, for which ANVISA states an average service time of 10 calendar days. Lei 14.874/2024 Article 28 §2 separately requires that import and export of experimental advanced therapies be authorized under specific regulation.

What is INAEP and what role does it play?

INAEP is the Instância Nacional de Ética em Pesquisa, the national ethics instance created by Lei 14.874/2024 Article 5 and structured by Decreto 12.651/2025. Under Article 8 of the statute it issues research ethics norms, credentials and accredits CEPs, monitors and inspects them, and serves as appellate instance over CEP decisions. For post-trial access, Decreto Article 31 §2 assigns INAEP the complementary guidelines for preparing, presenting and ethically reviewing the post-study plan and program. INAEP adopted its internal regulation on 2 April 2026 and held its first full-membership ordinary meeting on 14 August 2026.

What is the import mechanism for post-trial supply in Brazil?

For medicines, ANVISA RDC 38/2013. The sponsor or a contracted organização representativa do patrocinador files an anuência request; for post-study supply ANVISA issues not a comunicado especial but 'um ofício autorizando o fornecimento' (Art. 3 §2). The import licence is filed on the RDC 39/2008 form and may be submitted together with the anuência process (Art. 16). The Anexo I §IV dossier comprises the Anexo IV petition, the sponsor's Anexo VI and physician's Anexo VII declarations, the physician's CV, the Anexo VIII quantity estimate, and the trial's comunicado especial. Lei 14.874/2024 Article 34 §3 makes this prior authorization mandatory.

How does Brazil's 5-year commercial-availability tail work in practice?

Article 33 inciso VI permits interruption after 'transcurso do prazo de 5 (cinco) anos, contado da disponibilidade comercial do medicamento experimental no País'. The trigger is Brazilian commercial availability, not trial completion, marketing authorization elsewhere, or first commercial sale in another market. A sponsor that obtains ANVISA registration but delays Brazilian launch delays the start of its own five-year clock. Sponsors that never commercialize in Brazil cannot rely on inciso VI at all and must exit through one of the other six grounds, each of which requires a CEP-reviewed justification.

Tag: regulatory strategy

Clinical trial execution in Colombia: why we recommend it now

Colombia is now in scope for bioaccess® clinical-trial execution across all phases — first-in-human through pivotal — for both medical devices and drugs, in every indication. That is a reversal of our prior position, and the reason is that the regulator changed faster than the market narrative about it did.

INVIMA is one of eight national authorities certified by PAHO as a Regional Reference Regulatory Authority at Level IV, the highest level PAHO assigns for medicines regulation and surveillance in the Americas (INVIMA, Cooperación internacional; PAHO, Autoridades Regulatorias de Referencia). Since 2022 it has built a dedicated clinical-research group for devices, published its own approval and non-approval registries, and opened a public study search. Sponsors are still pricing Colombia on 2018 assumptions.

What changed since 2022

Three institutional facts, all documented by INVIMA itself.

First, devices got their own clinical-research function: INVIMA created the Grupo de Investigación Clínica y Apoyo a Sala Especializada DMRDIV (GICASE) through Resolución 2022035262 of 20 September 2022 (INVIMA, Investigación Clínica — Dispositivos). Second, the Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro (SEDMRDIV) now has an explicit mandate to evaluate and issue technical and methodological opinions on research protocols involving devices and in vitro diagnostic reagents (INVIMA, Sala especializada DMRDIV). Device sponsors have a named technical body, not an improvised one.

Third, INVIMA publishes what it approves and what it refuses: a register of device clinical studies approved from 2021 onward, a parallel register of studies not approved with the reason for each — non-approval, withdrawal, pending response — and a register of ethics-committee and research-site inspection status to November 2025 (INVIMA, Investigación Clínica — Dispositivos; register of non-approved device studies). Very few regulators in the region publish their rejections, and that register shows which protocol defects cost applicants a cycle. INVIMA’s public study search lists 1,157 clinical studies, 1,156 of them approved, 487 in progress and 523 completed, with a data date of 12 August 2026 (INVIMA, Lista de Estudios Clínicos).

The device pathway: prototype authorization through pivotal

Colombia has no single device clinical-trial regulation. It has three working instruments, and knowing which one carries which obligation is most of the job.

Decreto 4725 de 2005 is the sanitary regime for human-use medical devices. Article 2 defines a device intended for clinical investigation as one used by a specialist physician in research in an appropriate human clinical setting. Article 36 provides that a national or imported prototype device — or controlled-technology biomedical equipment — may be authorized only for research and experimentation, may not be used in health care, and requires an INVIMA technical opinion. Article 48(b) is the import hook: exceptional importation without sanitary registration or commercialization permit where the device is the subject of clinical research authorized in Colombia, subject to a prior opinion from the relevant specialized chamber. Article 18(k) closes the loop commercially — class IIb and III devices must present clinical studies to demonstrate safety and effectiveness when they later seek Registro Sanitario (Decreto 4725 de 2005).

Resolución 8430 de 1993 supplies the human-subjects framework — the scientific, technical and administrative rules for health research, including new prophylactic, diagnostic, therapeutic and rehabilitative resources (MinSalud) — and INVIMA names it as the governing instrument for research with human beings.

The operative paperwork is form-driven and published: ASS-RSA-FM085 (checklist for the prototype-device technical-opinion request), ASS-RSA-FM172 (SEDMRDIV technical-opinion request), ASS-RSA-FM169 (initial study evaluation completed by the ethics committee), ASS-RSA-FM170 (periodic reports) and ASS-RSA-FM171 (serious adverse event notification) (INVIMA, Investigación Clínica — Dispositivos). There is no ambiguity about what to file. There is considerable skill in filing it in a form the SEDMRDIV will not bounce.

The drug pathway

For medicines the anchor is Resolución 2378 de 2008, which adopted Good Clinical Practices with mandatory application for institutions conducting research with medicines in human beings (INS, Resolución 2378 de 2008). INVIMA requires approval for Phase I, II and III protocols and for Phase IV protocols with intervention; non-interventional Phase IV studies must still be submitted with a summary so INVIMA can determine whether formal approval applies (INVIMA, Fiscalización de Ensayos Clínicos).

Initial protocol evaluation is filed through Protocolos en Línea, the exclusive route for that procedure since 2 January 2020, under tariff 4070 for protocols and 4083 for amendments; adverse-event content and periodicity are set by Resolución 2011020764 de 2011, issued under Article 146 of Decreto 677 de 1995 (INVIMA, Fiscalización de Ensayos Clínicos).

Import of unregistered investigational medicines runs through Article 96 of Decreto 677 de 1995, which lets INVIMA exceptionally authorize importation without sanitary registration where INVIMA or the Ministry has authorized clinical research in the country, following a Comisión Revisora opinion and against a free-sale certificate, corporate documentation and analysis-fee receipts (Decreto 677 de 1995). Where the investigational product is a controlled substance, the monopoly is administered by the Fondo Nacional de Estupefacientes, and INVIMA expressly prioritizes those files in its current contingency plan (Resolución 2025046281 de 2025). Sponsors sometimes look for a separate narcotics department in the trial pathway; the correct counterparty is the FNE, and only for controlled product.

Timelines, and what the misconception gets wrong

The complaint about Colombia is that it is slow and unpredictable. Half of that is true.

Protocol volume has been flat for a decade — roughly 90 protocol-evaluation requests a year, 85 in 2014 and 87 in 2024 — and INVIMA’s average time to a definitive concept, approving or rejecting, is 5.1 months (ConsultorSalud, June 2025). Five months to a decision is not fast. It is a measured average with a published rejection register behind it, which makes it forecastable — unpredictability is the charge that does not survive contact with the data.

Country	Published regulatory clock for trial authorization	Source
Colombia	No statutory day-count; measured 5.1-month average to a definitive INVIMA concept	ConsultorSalud
Argentina	Disposición ANMAT 7516/2025 Art. 5 assigns evaluation to the Dirección de Investigación Clínica, states no day-count	Boletín Oficial
Chile	ISP: 45 business days to authorize import of unregistered pharmaceutical products for trial use	ISP Chile
Panama	Decreto Ejecutivo 21 de 2026 regulates Títulos III–IV of Ley 84 de 2019; no day-count published	MINSA Panamá

Three of the four comparators publish no binding clock at all. Colombia’s disadvantage on early-phase device work is smaller than the reputation suggests, and Colombia is the only one of the four that publishes both its approvals and its refusals.

Sites: Bogotá, Medellín, Cali

Colombia’s population was estimated at 53 million in 2025 (DANE, July 2025), and by December 2024 more than 160 centres held INVIMA Good Clinical Practice certification (ConsultorSalud).

INVIMA’s own register of approved research ethics committees places them in Bogotá, Medellín, Cali, Floridablanca and Montería, attached to established IPS and medical foundations (INVIMA, CEI list to May 2025). Bogotá, Medellín and Cali are the tier-1 clusters — high-volume tertiary hospitals, certified pharmacy and clinical-laboratory services inside the same certified institution, and investigator populations that read English protocols without translation. Floridablanca (Santander) and Montería extend regional recruitment reach.

Ethics committees

A Colombian trial needs a CEI approved by INVIMA and a site holding a current BPC certificate. That certificate is issued to the IPS after INVIMA verifies compliance with Resolución 2378 de 2008 through inspection visits, runs for five years, and requires evidence that the institution is registered under the Sistema Único de Habilitación with authorized pharmaceutical service, clinical laboratory and sample-collection services (INVIMA, Certificaciones en BPC). Replacing a site’s ethics committee is a formal BPC modification requiring a new-conditions verification visit and a written transfer plan agreed with sponsor, CRO and both committees. Sponsors who treat CEI selection as an afterthought lose weeks here.

Post-trial access in Colombia

Colombia does not currently mandate post-trial access by statute. Resolución 2378 de 2008 and Resolución 8430 de 1993 were both read in full for post-trial supply language and neither contains it; Resolución 8430 allocates only harm-related costs (Arts. 13, 15(j)–(k), 58(c)). bioaccess® can operate voluntary continuity programs in Colombia on sponsor request. Statutory PTA mandates in Latin America currently apply to Argentina, Brazil, Panama, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras and Nicaragua — not Colombia.

What is coming, and why it favours moving now

Three reform tracks are live. A draft unified sanitary regime would replace Decreto 4725 de 2005 and Decreto 3770 de 2004, adding conditional indefinite authorizations, international reliance mechanisms, mandatory UDI from first filing, four IVD risk classes on IMDRF parameters and an 18-month transition; it cleared national consultation and went to WTO public consultation (ConsultorSalud, June 2026). MinSalud has circulated a draft resolution on health research with human beings that would partially repeal Resolución 8430 de 1993 (ConsultorSalud, February 2026). And a clinical-research framework bill filed in the Cámara in August 2025 by Senator Fabián Díaz Plata and Representative Juan Daniel Peñuela Calvache would adopt ICH E6 and ISO 14155:2020 as the regulatory standard, create an INVIMA registry of authorized CROs and accredited investigators, and impose tacit approval — INVIMA objects within 7 calendar days for common-risk research and 30 for high-risk research, with ratification in a further 5 days (Cámara de Representantes, bill text). It classifies first-in-human studies and novel implantable devices as high-risk.

None is law yet. All three point the same direction, and each rewards sponsors who already hold Colombian sites, a certified CEI relationship and an INVIMA filing history when a transition period starts.

Registro Sanitario sits at the far end of the same pathway

Registro Sanitario is the INVIMA marketing authorization that lets a device be sold in Colombia, granted under Decreto 4725 de 2005 with technical evaluation under Article 18 and legal evaluation under Article 19; INVIMA may issue one request for additional information, with 90 days to respond, and BPM and CCAA certificates run for five years (Decreto 4725 de 2005). bioaccess® already runs Registro Sanitario market access in Colombia, and the reason to place trial and registration with one operator is Article 18(k): the clinical evidence a class IIb or III sponsor generates in Colombia is the evidence its Colombian registration will later be judged on.

Planning a first-in-human or pivotal trial in Colombia? bioaccess® is a US-headquartered, LATAM-native operator running regulatory submissions, importadora functions and 2–8 °C GDP cold chain across the region, and Colombia is now in scope for all phases, all indications, devices and drugs. To discuss INVIMA feasibility, site selection in Bogotá, Medellín or Cali, or a combined trial-plus-Registro-Sanitario pathway, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

Frequently asked questions

Does bioaccess® conduct clinical trials in Colombia?
Yes. As of September 2026 Colombia is in scope for bioaccess® clinical-trial execution across all phases, from first-in-human through pivotal, in all indications, for both medical devices and drugs. This is a change from our earlier position. The reversal follows documented institutional improvement at INVIMA since 2022 — a dedicated device clinical-research group, a named specialized chamber for device protocols, published approval and non-approval registries, and a public study search — combined with our own operating capability in Bogotá, Medellín and Cali. bioaccess® also runs INVIMA Registro Sanitario market access in Colombia, so the trial and the eventual marketing authorization can be sequenced by one operator.

What is INVIMA’s role in Colombian clinical trials?
INVIMA authorizes, monitors and can halt clinical research in Colombia. It evaluates both clinical aspects and the quality of the investigational product, requires approval for Phase I, II and III protocols and for interventional Phase IV protocols, and requires submission of non-interventional Phase IV studies so it can determine whether formal approval applies. It may interrupt an investigation or require modifications at any time if authorization conditions change, Good Clinical Practice is not met, or participant or public-health protection requires it. Sponsor-to-CRO delegations must be reported to INVIMA and remain the sponsor’s responsibility.

What is the INVIMA clinical-trial pathway for medical devices?
Three instruments combine. Decreto 4725 de 2005 Article 36 authorizes prototype devices for research and experimentation only, against an INVIMA technical opinion; Article 48(b) permits exceptional importation without sanitary registration where the device is the subject of clinical research authorized in Colombia, following a prior opinion from the specialized chamber; Article 18(k) later requires clinical studies for class IIb and III Registro Sanitario. Resolución 8430 de 1993 supplies the human-subjects rules. The SEDMRDIV issues the technical and methodological opinion, supported since September 2022 by the GICASE group created under Resolución 2022035262.

What is the INVIMA clinical-trial pathway for drugs?
Resolución 2378 de 2008 adopted Good Clinical Practices with mandatory application for institutions researching medicines in humans, and is the basis of the site BPC certificate. Initial protocol evaluation is filed through INVIMA’s Protocolos en Línea platform, exclusive for that procedure since 2 January 2020, under tariff 4070 for protocols and 4083 for amendments. Adverse-event reporting content and periodicity follow Resolución 2011020764 de 2011, issued under Article 146 of Decreto 677 de 1995. Importation of unregistered investigational medicines runs under Article 96 of Decreto 677 de 1995 with a Comisión Revisora opinion. Controlled substances involve the Fondo Nacional de Estupefacientes, which administers that monopoly.

What are typical INVIMA authorization timelines in 2026?
There is no statutory day-count in force for protocol authorization. The measured figure is an average of 5.1 months from filing to a definitive INVIMA concept, approving or rejecting, against a stable volume of roughly 90 protocol-evaluation requests a year. Sponsors should plan the ethics-committee approval, the INVIMA concept and the import authorization as sequential rather than parallel steps. The clinical-research bill filed in August 2025 would replace the current position with tacit approval — 7 calendar days for common-risk and 30 for high-risk studies — but it is not law.

Does Colombia require post-trial access?
No. Colombia does not currently mandate post-trial access by statute. Resolución 2378 de 2008 and Resolución 8430 de 1993 contain no post-trial supply obligation; Resolución 8430 allocates only harm-related costs. bioaccess® can operate voluntary continuity programs in Colombia on sponsor request, governed by the protocol, the informed consent and the ethics committee’s expectations rather than by statute. Statutory PTA mandates in Latin America currently apply to Argentina, Brazil, Panama, Chile, Peru, Ecuador, Costa Rica, Guatemala, Honduras and Nicaragua.

What is INVIMA Registro Sanitario?
Registro Sanitario is the INVIMA authorization required to market a medical device in Colombia, granted under Decreto 4725 de 2005 following technical evaluation under Article 18 and legal evaluation under Article 19. INVIMA may issue one request for additional or clarifying information, and the applicant has 90 days to respond before the file is deemed abandoned. Manufacturing and storage certificates — BPM and CCAA — are valid for five years. For class IIb and III devices, Article 18(k) requires clinical studies demonstrating safety and effectiveness, which is why trial design and registration strategy belong in the same plan.

Which Colombian cities have the best clinical-trial infrastructure?
Bogotá, Medellín and Cali are the tier-1 clusters, and INVIMA’s own register of approved ethics committees places committees in those three cities plus Floridablanca and Montería, attached to established IPS and medical foundations. More than 160 centres held INVIMA Good Clinical Practice certification as of December 2024. The practical selection criterion is not city size but whether the certified institution holds authorized pharmaceutical service, clinical laboratory and sample-collection services inside the same habilitación, because a contracted service adds documentation to every BPC modification.

How does Colombia compare to Argentina, Panama and Chile for early-phase device trials?
On published regulatory clocks, three of the four disclose nothing binding. Argentina’s Disposición 7516/2025 Article 5 assigns protocol evaluation to ANMAT’s Dirección de Investigación Clínica without stating a day-count. Panama’s Decreto Ejecutivo 21 of 23 April 2026 regulates Títulos III and IV of Ley 84 de 2019 with no authorization day-count on the MINSA page. Chile’s ISP publishes 45 business days for the resolution authorizing import of unregistered pharmaceutical products for trial use. Colombia publishes no clock but has a measured 5.1-month average and, unlike the other three, publishes both its approvals and its refusals for device studies.

What has changed at INVIMA since 2022?
Resolución 2022035262 of 20 September 2022 created the GICASE group for device clinical research and support to the specialized chamber. The SEDMRDIV now carries an explicit mandate to evaluate device and IVD research protocols. INVIMA publishes registers of approved device studies, non-approved device studies with reasons, SEDMRDIV import authorizations for observational studies, and ethics-committee and site inspection status to November 2025. Its public study search reported 1,157 studies with a data date of 12 August 2026. INVIMA also remains one of eight PAHO Level IV Regional Reference Regulatory Authorities.

Sources

INVIMA — Cooperación internacional (PAHO Level IV ARNr status): https://www.invima.gov.co/el-instituto/cooperacion-internacional
PAHO/OPS — Autoridades Regulatorias de Referencia: https://www.paho.org/es/autoridades-regulatorias-referencia
INVIMA — Investigación Clínica, Dispositivos (GICASE, Resolución 2022035262 de 2022, forms ASS-RSA-FM085/169/170/171/172, published registers): https://www.invima.gov.co/productos-vigilados/dispositivos-medicos/investigacion-clinica
INVIMA — Sala especializada de dispositivos médicos y reactivos de diagnóstico in vitro: https://www.invima.gov.co/productos-vigilados/dispositivos-medicos/sala-especializada-dispositivos-reactivos
INVIMA — Registro de estudios clínicos con dispositivos médicos no aprobados 2021–2025: https://www.invima.gov.co/biblioteca/registro-estudios-clinicos-dispositivos-medicos-no-aprobados-invima-2021-2025
INVIMA — Lista de Estudios Clínicos (public study search, data date 12 August 2026): https://www.invima.gov.co/estudios
INVIMA — Fiscalización de Ensayos Clínicos, Medicamentos (Protocolos en Línea, tariffs 4070/4083, Resolución 2011020764 de 2011): https://www.invima.gov.co/productos-vigilados/medicamentos-y-productos-biologicos/medicamentos-de-sintesis-quimica-y-biologica/ensayos-clinicos
INVIMA — Procesos de certificación en Buenas Prácticas Clínicas (BPC certificate, 5-year validity): https://www.invima.gov.co/productos-vigilados/medicamentos-y-productos-biologicos/medicamentos-de-sintesis-quimica-y-biologica/licenciamiento-auditorias-y-certificaciones/certificaciones-en-buenas-practicas
INVIMA — Listado de Comités de Ética en Investigación aprobados a mayo 2025: https://www.invima.gov.co/biblioteca/comites-etica-investigacion-aprobados-invima-2025
Decreto 4725 de 2005 (Arts. 2, 18, 19, 21, 22, 36, 48, 89) — Función Pública, Gestor Normativo: https://www.funcionpublica.gov.co/eva/gestornormativo/norma.php?i=18697
Decreto 677 de 1995 (Art. 96 exceptional import; Arts. 145–146) — INVIMA normograma: https://normograma.invima.gov.co/compilacion/docs/decreto_0677_1995.htm
Resolución 2378 de 2008 (Buenas Prácticas Clínicas) — Instituto Nacional de Salud: https://www.ins.gov.co/Normatividad/Resoluciones/RESOLUCION%202378%20DE%202008.pdf
Resolución 8430 de 1993 — MinSalud: https://www.minsalud.gov.co/sites/rid/Lists/BibliotecaDigital/RIDE/de/dij/resolucion-8430-DE-1993.PDF
Resolución INVIMA 2025046281 de 19 de septiembre de 2025 (contingency plan; Fondo Nacional de Estupefacientes prioritization): http://normograma.invima.gov.co/normograma/compilacion/docs/resolucion_invima_46281_2025.htm
Resolución INVIMA 2025010547 de 19 de marzo de 2025 (Plan de Contingencia): https://normograma.invima.gov.co/compilacion/docs/resolucion_invima_10547_2025.htm
DANE — Nota Técnica, Proyecciones de Población, July 2025 (53 million in 2025): https://www.dane.gov.co/files/censo2018/proyecciones-de-poblacion/Nacional/NotaTecnica-PPED-jul2025.pdf
Cámara de Representantes — clinical-research framework bill, August 2025 (tacit approval 7/30 days, ICH E6, ISO 14155:2020): https://hcrpruebas.camara.gov.co/wp-content/uploads/2025/08/proyectos_ley/25082025_25082025_ver_documento_17.pdf
ConsultorSalud, 25 June 2025 — INVIMA average 5.1 months to definitive concept; ~90 protocols/year; 160+ BPC-certified centres: https://consultorsalud.com/colombia-reto-regulacion-estudios-clinicos/
ConsultorSalud, June 2026 — draft unified medical device sanitary regime replacing Decretos 4725/2005 and 3770/2004: https://consultorsalud.com/regimen-unico-dispositivos-medicos-impactos/
ConsultorSalud, February 2026 — MinSalud draft resolution partially repealing Resolución 8430 de 1993: https://consultorsalud.com/minsalud-investigacion-salud-seres-humanos-ips/
Disposición ANMAT 7516/2025, Art. 5 — Boletín Oficial de la República Argentina: https://www.boletinoficial.gob.ar/detalleAviso/primera/332695/20251009
Instituto de Salud Pública de Chile — 45 business days for trial import authorization: https://www.ispch.gob.cl/pregunta-frecuente/p-141/
MINSA Panamá — Decreto Ejecutivo N° 21 de 23 de abril de 2026: https://www.minsa.gob.pa/normatividad/decreto-ejecutivo-ndeg-21-jueves-23-de-abril-2026-que-reglamenta-los-titulos-iii-y-iv
bioaccess® — Colombia clinical trial regulatory guide: https://bioaccessla.com/regulatory-guide/colombia

September 6, 2026

The legal architecture of Latin American post-trial access: SDEA, DPA, product liability, sponsor accession

A Latin American post-trial access (PTA) program is a regulatory filing wrapped in four contracts. The filing is the visible part — an ANMAT import expediente, an ANVISA ofício, a DIGEMID authorization. The four contracts are what determine who answers to a regulator, who answers to a patient, and who answers to a plaintiff’s lawyer three years after the last shipment.

Those four instruments are a Safety Data Exchange Agreement, a country-specific Data Processing Agreement, a product-liability allocation, and — the one most often missing — a sponsor accession mechanism that binds the marketing-authorization holder to the same schedules the operator signed. This piece sets out how we paper each of them and the five architectural mistakes that recur in draft PTA agreements we review.

Why the paperwork carries more weight than the filing

In nine Latin American jurisdictions the continued-supply duty is statutory and sits on the sponsor. Brazil’s Lei nº 14.874/2024 Art. 31 §4 states that “o fornecimento do medicamento será de responsabilidade do patrocinador,” and Art. 33 inciso VI releases the sponsor only five years after commercial availability in Brazil. Chile’s Código Sanitario Art. 111 C, inserted by Art. 34 of Ley 20.850, attaches the free-supply duty to the holder of the provisional-use authorization and then to the sanitary-registration holder — including a successor that acquired the registration later. Peru’s DS 021-2017-SA Art. 40(p) and Art. 89 put both the access duty and the funding on the sponsor. Panama’s Decreto Ejecutivo 21/2026 Art. 68 (Gaceta Oficial Digital 30510-C, 23 April 2026, which reglamentates Titles III and IV of Ley 84 de 14 de mayo de 2019) names investigadores y patrocinadores as co-obligors.

None of those statutes names an operator, an importadora, or a managed-access vendor. The obligation is the sponsor’s by law. Everything the operator does — the import authorization under Disposición ANMAT 12792/2016 Art. 4, the cold-chain leg, the pharmacovigilance intake — is performed on behalf of an obligor that remains the obligor. If the contract does not say so with precision, the operator has effectively assumed a statutory duty it has no legal standing to discharge.

Pillar 1: the Safety Data Exchange Agreement

The SDEA is the instrument that connects local adverse-event intake to the sponsor’s global pharmacovigilance system. It should be executed within 30 days of the Work Order, not left to a later “PV annex to follow.”

Three ICH guidelines set the substance. ICH E2A fixes the expedited-reporting clock: fatal or life-threatening unexpected adverse drug reactions require notification “as soon as possible but no later than 7 calendar days after first knowledge by the sponsor,” followed by a fuller report “within 8 additional calendar days” (§III.B.1), while all other serious unexpected ADRs run on a 15-calendar-day clock (§III.B.2). Because the clock starts on sponsor knowledge, the SDEA must set an internal onward-transmission deadline for the local operator that is materially shorter — otherwise the sponsor’s regulatory clock is being consumed by the operator’s intake queue. ICH E2F governs periodic reporting: the DSUR is an annual report with a data lock point on “the last day of the one-year reporting period” and submission “no later than 60 calendar days after the DSUR data lock point” (§2.2), so the SDEA must specify who supplies PTA-cohort line listings into that cycle and by when. ICH E3 §12 sets the safety-evaluation structure the underlying trial report already follows, which is the format PTA safety data should feed into rather than a parallel one.

Practical drafting points: name the sponsor’s global PV mailbox and the operator’s PV contact by role, define the reconciliation cadence, and state expressly that regulatory reporting to the local authority is the sponsor’s obligation performed through the operator as agent, with the operator’s duty limited to timely, accurate onward transmission.

Pillar 2: the Data Processing Agreement — country by country

There is no single Latin American data-protection instrument, so there is no single DPA. The controlling article set changes by jurisdiction:

Jurisdiction	Instrument	Transfer article	Notes for PTA drafting
Argentina	Ley 25.326	Art. 12(1)–(2)	Transfer to countries without adequate protection is prohibited; Art. 12(2)(b) carves out medical-data exchange where the affected person’s treatment requires it. Art. 11(4) makes the transferee subject to the transferor’s obligations and imposes joint liability.
Argentina (clauses)	AAIP Resolución 198/2023	Anexo I	Approves two model clause sets: responsable–responsable and responsable–encargado. Use the latter where the operator processes only on sponsor instruction (Cláusula 6.1).
Brazil	Lei nº 13.709/2018 (LGPD)	Arts. 33–36	Art. 33 II(a)–(b) permits transfer on specific or standard contractual clauses; Art. 33 VIII permits it on specific, highlighted consent distinguished from other purposes.
Mexico	LFPDPPP (DOF 20 March 2025)	Arts. 35–36	Health data is sensitive (Art. 2 fr. VI) and requires express written consent (Art. 8). Art. 36 fr. II exempts transfers necessary for medical treatment or health-service management.
Chile	Ley 19.628 → Ley 21.719	Art. 10 → Arts. 27–29	Ley 21.719 was published 13 December 2024 and enters into force 1 December 2026. Any Chilean PTA DPA signed now should be drafted to the Arts. 27–29 transfer regime, not only to Ley 19.628 Art. 10.
Peru	DS 016-2024-JUS (Reglamento, Ley 29733)	Arts. 18–20	In force 120 calendar days after publication (31 March 2025). Art. 20.1 permits model contractual clauses imposing “cuando menos las mismas obligaciones” on the importer.
Colombia	Ley Estatutaria 1581 de 2012	Art. 26	Health data is sensitive (Art. 5); Art. 26(b) carves out medical-data exchange required by the data subject’s treatment. Otherwise the SIC issues a declaración de conformidad (Art. 26, par. 1).

The operator-side drafting position is the same everywhere: the sponsor is responsable/controller, the operator is encargado/operator, processing is limited to documented instructions, sub-processing requires prior written consent, and the operator returns or deletes on termination subject to statutory retention. Where the destination country has no adequacy finding, attach the applicable model clauses as a schedule rather than describing them in the body.

The Argentina adequacy mistake

The most common error in Argentine PTA drafting is treating Commission Decision 2003/490/EC as if it authorised outbound transfers from Argentina. Article 1 reads: “Argentina is regarded as providing an adequate level of protection for personal data transferred from the Community.” Article 2 confines the decision to adequacy in Argentina “with a view to meeting the requirements of Article 25(1) of Directive 95/46/EC.” The instrument is unidirectional — EU to Argentina.

A PTA data flow from Argentine sites to a sponsor in the United States, or to an access vendor in the Netherlands, is an Argentine outbound transfer governed by Ley 25.326 Art. 12, and the correct instrument is the AAIP responsable–encargado model agreement under Resolución 198/2023, not a citation to the 2003 decision. Treating the adequacy finding as reciprocal is a defect that survives review because it looks like a considered legal position.

Pillar 3: product liability sits with the sponsor

The operator is not the manufacturer, does not hold the marketing authorization, and cannot practically bear product-liability risk for the product itself. A managed-access or expanded-access vendor is in the same position. Neither controls design, manufacture, batch release, labelling content, or the safety profile — so neither can defend a product claim on the merits or insure it economically.

Our drafting position, and the position we recommend to any operator in this role:

The sponsor or titular defends and indemnifies the operator against third-party claims arising from the product itself, including design, manufacture, and labelling defects.
The sponsor maintains product-liability insurance covering the PTA territories for the duration of the program plus a tail, and provides certificates on request.
The operator’s liability cap covers operator services only. Product liability sits outside the cap.
Carve-outs outside the cap in both directions: gross negligence, wilful misconduct, breach of confidentiality, intellectual-property infringement, and breach of data-protection obligations.

The cap itself is negotiable, usually expressed against fees paid under the Work Order over a defined lookback. Its composition is not: a cap that silently absorbs product liability converts a services agreement into an uninsured product warranty.

Pillar 4: sponsor accession as a condition precedent

Because the sponsor holds the statutory supply duty, the product liability, the marketing authorization, and the primary pharmacovigilance obligation, an operator’s Work Order should be conditioned on sponsor accession. Two mechanisms work:

Direct accession — the sponsor executes a short accession instrument to the schedules that allocate safety data exchange, data processing, and liability (in our template set, schedules C, E and F).
Tripartite side letter — the sponsor, the access vendor or intermediary, and the operator sign a single side letter confirming the sponsor’s indemnity, insurance, PV ownership, and patient-continuity funding, with the underlying Work Order otherwise unchanged.

Either way the Work Order should not become effective until accession is signed. Without it, the operator holds a services contract with a counterparty that cannot deliver the indemnity the contract assumes, and the patient-continuity commitment has no funded obligor behind it.

Five architectural mistakes we see repeatedly

No sponsor accession condition. The operator signs with an intermediary and inherits an unfunded, uninsurable duty.
Product liability inside the operator’s cap. Structurally wrong for a non-manufacturer.
The reciprocal-adequacy error. Argentina→US or Argentina→NL flows papered as if Decision 2003/490/EC covered them.
No patient-continuity run-off. Termination should trigger a defined run-off — our default is 90 days — during which supply, PV intake, and cold-chain continue at the sponsor’s cost.
No sponsor-funded continuity trigger. If the sponsor terminates the program or the access vendor disengages, the continuity obligation must be expressly sponsor-funded, or patients absorb the commercial dispute.

Governing law, dispute resolution, and pre-send gates

For cross-border PTA services agreements with a US-headquartered operator, Delaware law with AAA-ICDR arbitration seated in New York is a sensible default: neutral to the LATAM performance jurisdictions, familiar to sponsor counsel, and enforceable across the region under the New York Convention. Local-law carve-outs remain necessary for the statutory duties themselves, which are not contractible away.

Before any PTA agreement leaves our desk it passes four gates: (1) a counsel memo verifying the regulatory framework and article citations for each performance jurisdiction; (2) named performing entities, including the habilitada local entity and the importadora of record; (3) sponsor accession path agreed in principle, in writing, before signature; and (4) harmonized statutory-obligation language, so that the same duty is not described one way in the recitals and another way in the schedules.

Frequently asked questions

What legal architecture does a LATAM post-trial access program require?
Four instruments beyond the services agreement itself: a Safety Data Exchange Agreement connecting local adverse-event intake to the sponsor’s global pharmacovigilance system; a country-specific Data Processing Agreement built on the applicable transfer article (Argentina Ley 25.326 Art. 12, Brazil LGPD Arts. 33–36, Colombia Ley 1581 Art. 26, and so on); a product-liability allocation placing defence, indemnity, and insurance on the sponsor or titular; and a sponsor accession mechanism binding the marketing-authorization holder to those schedules. The regulatory filing — import authorization, ethics submission — is separate and downstream.

What is a Safety Data Exchange Agreement (SDEA) in PTA?
An SDEA is the bilateral agreement that defines how safety information moves from the PTA site and local operator into the sponsor’s global pharmacovigilance system. It should be executed within 30 days of the Work Order and built on ICH principles: ICH E2A §III.B for the 7-day and 15-calendar-day expedited-reporting clocks, ICH E2F §2.2 for annual DSUR periodicity and the 60-day post-data-lock-point submission window, and ICH E3 §12 for the safety-evaluation structure the data must fit. It names PV contacts, sets onward-transmission deadlines shorter than the sponsor’s regulatory clock, and fixes a reconciliation cadence.

What is a Data Processing Agreement (DPA) in Argentine PTA?
It is the instrument that makes an Argentine PTA data flow lawful under Ley 25.326. Art. 12(1) prohibits transfer to countries or organisations that do not provide adequate protection levels, and Art. 11(4) makes the transferee subject to the transferor’s obligations with joint liability. Where the sponsor sits in a country without an Argentine adequacy finding, the practical route is the responsable–encargado model agreement approved by AAIP Resolución 198/2023, attached as a schedule. Cláusula 6.1 limits the importer to the exporter’s documented instructions, with no decision-making power over scope or content.

Does EU Commission Decision 2003/490/EC cover Argentina→US or Argentina→EU data flows?
No. Article 1 of Decision 2003/490/EC regards Argentina as adequate for “personal data transferred from the Community,” and Article 2 limits the decision to adequacy in Argentina for the purposes of Article 25(1) of Directive 95/46/EC. The decision is unidirectional: EU to Argentina. An outbound transfer from Argentine sites to a US sponsor or a Dutch access vendor is governed by Ley 25.326 Art. 12 and requires its own adequacy basis, statutory exception, or model clauses. Article 3 of the decision, in fact, gives EU authorities power to suspend flows to recipients in Argentina — the opposite of a reciprocal permission.

Who bears product liability in a PTA program — the sponsor, the manufacturer, or the operator?
The sponsor or the titular of the marketing authorization. The operator is not the manufacturer, does not hold the authorization, and does not control design, manufacture, batch release, or labelling — so it cannot defend a product claim on the merits or insure it at a rational price. The correct architecture has the sponsor defend and indemnify the operator for product-related third-party claims, maintain product-liability insurance covering the PTA territories for the program term plus a tail, and accept that product liability sits outside the operator’s services liability cap.

Why should PTA operators condition the Work Order on sponsor accession?
Because the sponsor holds every obligation the Work Order depends on: the statutory continued-supply duty, the marketing authorization, primary pharmacovigilance responsibility, product liability, and the funding for patient continuity. An operator that contracts only with an intermediary holds an indemnity from a party that does not control the product and a continuity commitment with no funded obligor. Making accession a condition precedent — rather than a post-signature action item — is the only reliable way to ensure the risk allocation in the schedules is enforceable against the party that can actually perform it.

What is a tripartite side letter in LATAM PTA?
A single short instrument signed by the sponsor, the access vendor or intermediary, and the local operator, used where the sponsor will not accede directly to the operator’s schedules. It confirms four things: the sponsor’s defence and indemnity for product-related claims; the sponsor’s product-liability insurance covering the PTA territories; sponsor ownership of primary pharmacovigilance and regulatory reporting; and sponsor funding of patient continuity, including any run-off period. It leaves the underlying Work Order commercial terms untouched, which is usually why it is the faster path to signature.

What is the standard liability cap in a LATAM PTA Work Order?
There is no single market standard, and any figure quoted as one should be treated with suspicion. Caps are typically expressed as a ceiling tied to fees paid under the Work Order over a defined lookback period. The more consequential negotiation is not the number but the composition — what the cap covers and what sits outside it. A cap that quietly includes product liability turns a services agreement into an uninsured product warranty, which is a worse outcome for the operator than a low number with clean carve-outs.

What carve-outs should sit outside the liability cap?
Five, in both directions: gross negligence, wilful misconduct, breach of confidentiality, intellectual-property infringement, and breach of data-protection obligations. Product liability should also sit outside the operator’s cap, because the operator is not the manufacturer. Data-protection breach deserves particular attention in Latin America: Argentina’s Ley 25.326 Art. 11(4) imposes joint liability between transferor and transferee, and Mexico’s LFPDPPP Art. 59 fr. IV allows sanctions for sensitive-data infractions to be increased up to twofold, so capped data-protection exposure can be materially lower than actual statutory exposure.

What is the standard patient-continuity run-off period?
Our default drafting position is 90 days from the effective date of termination. During that window, product supply, pharmacovigilance intake, and cold-chain and importation services continue at the sponsor’s cost while the sponsor arranges an alternative route — a successor operator, an extension study, or transition into commercial or public-system supply. The reason to fix a defined period rather than “a reasonable transition” is that the statutory obligations do not pause: Brazil’s Lei 14.874/2024 Art. 33 lists exhaustive interruption grounds, and contract termination between a sponsor and its operator is not one of them.

Should managed-access-program specialists require sponsor accession too?
Yes, and for the same structural reason. A managed-access or expanded-access specialist occupies the same position as a regional operator: it is not the manufacturer, does not hold the marketing authorization, and cannot bear product-liability risk for the product. Whether the intermediary is a global access platform, a specialty distributor, or a regional CRO, the party with the statutory supply duty and the insurable product risk is the sponsor. Any access architecture that leaves the sponsor outside the contractual chain has a gap at exactly the point where a patient-harm claim would land.

Working on a LATAM post-trial access program? bioaccess® is a US-headquartered, LATAM-native operator running regulatory, importadora, and 2–8 °C GDP cold-chain functions directly across the region. If you’re evaluating PTA feasibility in Argentina, Brazil, Chile, Peru, Panama, Mexico or Colombia, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

Sources

ICH E2A, Clinical Safety Data Management: Definitions and Standards for Expedited Reporting — https://database.ich.org/sites/default/files/E2A_Guideline.pdf
ICH E2F, Development Safety Update Report — https://database.ich.org/sites/default/files/E2F_Guideline.pdf
ICH E3, Structure and Content of Clinical Study Reports — https://database.ich.org/sites/default/files/E3_Guideline.pdf
Commission Decision 2003/490/EC of 30 June 2003 (Argentina adequacy) — https://eur-lex.europa.eu/legal-content/EN/TXT/HTML/?uri=CELEX:32003D0490
Argentina, Ley 25.326 (Protección de los Datos Personales) — https://servicios.infoleg.gob.ar/infolegInternet/anexos/60000-64999/64790/texact.htm
Argentina, AAIP Resolución 198/2023 (RESOL-2023-198-APN-AAIP, BO 18/10/2023), model international-transfer clauses — https://servicios.infoleg.gob.ar/infolegInternet/anexos/390000-394999/391538/norma.htm
Argentina, AAIP Resolución 198/2023 Anexo I (IF-2023-108581614-APN-DNPDP#AAIP) — https://servicios.infoleg.gob.ar/infolegInternet/anexos/390000-394999/391538/res198.pdf
Argentina, Disposición ANMAT 12792/2016 (post-study import procedure) — https://www.boletinoficial.gob.ar/detalleAviso/primera/154162/20161117
Argentina, Disposición ANMAT 7516/2025 (GCP, in force 1 December 2025) — https://www.boletinoficial.gob.ar/detalleAviso/primera/332695/20251009
Brazil, Lei nº 13.709/2018 (LGPD) — https://www.planalto.gov.br/ccivil_03/_ato2015-2018/2018/lei/l13709.htm
Brazil, Lei nº 14.874/2024, Arts. 30–37 — https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2024/lei/l14874.htm
Brazil, Decreto nº 12.651/2025, Art. 31 — https://www2.camara.leg.br/legin/fed/decret/2025/decreto-12651-7-outubro-2025-798105-publicacaooriginal-176652-pe.html
Mexico, Ley Federal de Protección de Datos Personales en Posesión de los Particulares (DOF 20 March 2025; last reform DOF 14 November 2025) — https://www.diputados.gob.mx/LeyesBiblio/pdf/LFPDPPP.pdf
Chile, Ley 19.628 sobre Protección de la Vida Privada — https://www.bcn.cl/leychile/navegar?idNorma=141599
Chile, Ley 21.719 (published 13 December 2024; in force 1 December 2026) — https://www.bcn.cl/leychile/navegar?idNorma=1209272
Chile, Ley 20.850 and Código Sanitario Art. 111 C — https://www.bcn.cl/leychile/navegar?idNorma=1078148
Peru, Decreto Supremo N° 016-2024-JUS (Reglamento de la Ley 29733) — https://www.gob.pe/institucion/anpd/normas-legales/6554453-16-2024-jus
Peru, Reglamento de Ensayos Clínicos, DS 021-2017-SA, Arts. 115–118 — https://ensayosclinicos-repec.ins.gob.pe/images/Reglamento_de_EC.pdf
Colombia, Ley Estatutaria 1581 de 2012 — https://www.funcionpublica.gov.co/eva/gestornormativo/norma.php?i=49981
Panama, Decreto Ejecutivo No. 21 de 23 de abril de 2026, Art. 68, Gaceta Oficial Digital No. 30510-C (primary-source Gaceta PDF, read 6 September 2026)

September 6, 2026

Post-trial access in Peru under DS 021-2017-SA

Peru obliges sponsors to keep supplying the investigational product, free of charge, to participants who are still benefiting after a trial ends. The duty lives in Título X (Arts. 115–118) of the Reglamento de Ensayos Clínicos approved by Decreto Supremo N.° 021-2017-SA, and it covers medical devices as well as drugs.

What makes Peru different from the rest of Latin America is not the strength of the obligation but its drafting. Most regional PTA mandates state a duty and stop. Peru states the duty, names two authorization routes, lists the exact documents required for one of them, and assigns the post-access safety reporting. That specificity is why Peru is the most operationally tractable post-trial access market in the region.

The obligation: Article 115 and Article 40(p)

Article 115 defines post-study access as the free availability, to the research subject, of the investigational product studied in the trial — expressly including products that already hold a Peruvian sanitary registration — after the study closes or after that subject’s participation ends. It also requires that post-study access be anticipated before the study begins and disclosed during the informed consent process (DS 021-2017-SA, Art. 115).

The same instrument places the duty on the sponsor directly. Article 40(p) makes the sponsor responsible for “asegurar el acceso de los sujetos de investigación, después de la culminación del ensayo clínico al producto de investigación” under the terms of Título X, and adds that this must be specified in the informed consent form. Article 40(s) separately requires free access to the investigational product, complementary products and trial procedures during participation — so the Peruvian scheme is continuous rather than a distinct post-close programme bolted on later.

Article 115 sets conditions for when the duty is enforceable: the seriousness of the medical condition, the effect of withdrawing or modifying treatment, the absence of satisfactory therapeutic alternatives in Peru for that subject’s condition, sufficient efficacy and safety information, and a positive benefit-risk balance. The product must have proved beneficial to the subject in the principal investigator’s judgment, and “su uso se mantendrá en cuanto hubiere beneficio” — supply continues as long as benefit continues. There is no fixed end date.

One clause matters in feasibility modelling. Where the pathology falls under the management of a MINSA General Directorate, the sponsor must maintain access “hasta que le sea accesible a través de dichas direcciones” — until the patient can obtain the product through the public system. For conditions inside a national programme, that converts an open-ended commitment into a handoff with a definable end state. For conditions outside one, it does not.

Who pays

The sponsor. Article 89 states that investigational products for use in clinical trials “serán financiados por el patrocinador y proporcionados gratuitamente al sujeto de investigación.” Read with Article 115’s “disponibilidad gratuita” and Article 40(p), there is no cost-sharing construct available in Peru — not co-payment, not reimbursement, not a named-patient sale. Budget the cost of goods, import, storage, dispensing and destruction as sponsor expense for the full benefit period.

Devices are in scope

Article 2, numeral 2.1, item 36 defines “producto en investigación” as “un producto farmacéutico o dispositivo médico” investigated or used as a comparator in a clinical trial, referring both terms back to Ley N.° 29459. Título X operates on “producto en investigación,” so the post-trial access duty applies textually to device trials, not only pharmaceutical ones.

A device PTA commitment can mean continued supply of consumables, continued availability of an implanted system’s disposables, or continued technical support — and the Reglamento gives no device-specific carve-out. We treat device PTA exposure in Peru as live from protocol design onward.

Two authorization routes under Article 116

Article 116 provides that post-study access may be authorized through either of two mechanisms:

Route 1 — an extension clinical trial authorized by OGITT. The Oficina General de Investigación y Transferencia Tecnológica of the Instituto Nacional de Salud grants authorization for a trial that constitutes an extension study, following the ordinary trial-authorization requirements in Article 67. Under Article 7, the INS is the national authority responsible for enforcing the Reglamento and for authorizing and overseeing clinical trials.

Route 2 — case-by-case authorization by the ANM. The Reglamento’s abbreviation table defines ANM as the Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios. In practice that authority is DIGEMID, which describes itself as “la Autoridad Nacional responsable de garantizar la eficacia, seguridad y calidad de los productos farmacéuticos, dispositivos médicos y productos sanitarios” and lists among its functions to “emitir opinión técnica vinculante y supervisar la autorización de los productos y dispositivos en investigación en el marco de lo dispuesto en el Reglamento de Ensayos Clínicos en el Perú” (DIGEMID, Institución).

Article 116 also fixes the trigger sequence: the principal investigator who considers post-study access appropriate for a subject communicates that to the sponsor, and the sponsor — not the investigator, not the site — files the application with the ANM.

The routes are not interchangeable. An extension trial suits a defined cohort continuing on protocol with a data objective, and carries full trial-authorization machinery: ethics committee approval, insurance, reporting. The ANM route suits individual patients continuing after close, with no research objective. Choosing between them is the first decision in a Peru PTA plan.

Article 117: the seven-document set

The reason Peru is productizable is Article 117. For the ANM route, authorization is granted “para cada caso concreto,” on application by the sponsor that ran the trial, and the requirements are enumerated:

#	Article 117 requirement
a	Application for authorization addressed to the ANM
b	Written informed consent of the subject or legal representative, signed by the subject and the principal investigator
c	Clinical report in which the principal investigator justifies the need for the treatment
d	Duly completed official medical prescription (receta médica oficial)
e	Agreement of the person responsible for the institution or establishment where the treatment will be applied
f	Updated investigator’s brochure, as applicable
g	Copy of the resolución directoral authorizing the clinical trial from which the case derives

Two of the seven are not sponsor-controlled — item (d) requires a Peruvian official prescription and item (e) requires institutional sign-off from the treating site. Those are the items that slip. Item (g) is why trial-close document retention matters: sponsors that archive the resolución directoral badly discover it when a case is already pending. Because the list is closed and enumerated, the scope of work is definable in advance: one dossier per patient, seven artifacts, two requiring site coordination. That is a service specification, not an open-ended regulatory exercise.

Import, dispensing and product handling

PTA supply still has to physically enter Peru and reach the patient under the Reglamento’s product rules. Article 94 provides that the ANM authorizes importation of the investigational product and complementary products by resolución directoral specifying the authorization’s validity period, and must issue it within three business days of application, against four documents: the import application, a copy of the OGITT trial authorization, a list of products and supplies, and proof of fee payment.

Downstream, Article 92 requires dispensing through a Unidad de Dispensación para Ensayos Clínicos within the pharmacy service of the research institution, under Good Storage and Good Dispensing Practices. Article 91 requires investigational-product labelling to carry “Solo para uso en investigación” and “Prohibida su venta.” Article 96 requires that unused or returned product be destroyed in the presence of a notary public, with the knowledge of the ANM and OGITT. A PTA programme inherits all of it.

Timelines that are actually in the regulation

The Reglamento states review periods for the trial-authorization route but not for the Article 117 case authorization.

Step	Statutory period	Source
ANM technical opinion on safety and quality of the investigational product	30 business days (45 for biologics)	Art. 69
OGITT resolution authorizing a clinical trial, including the ANM opinion	40 business days (60 for biologics or where technical commissions are convened)	Art. 70
ANM import authorization by resolución directoral	3 business days	Art. 94
ANM case-by-case post-study access authorization (Art. 116–117)	No period stated in the Reglamento	—

Article 70 also suspends the clock when the authority requests supplementary information, so the 40-business-day figure is a floor on a clean file rather than a service level. Sponsors planning a Peru PTA bridge should build the Route 1 schedule from Article 70 and treat Route 2 duration as an assumption to be confirmed with the ANM for the specific case, not a published commitment.

Pharmacovigilance after access begins

Article 118 does not release the sponsor at authorization. The sponsor must report treatment results to the ANM within the established period, along with suspected adverse drug reactions, without prejudice to reporting to the corresponding territorial health authority. Peru PTA is therefore a supervised supply arrangement with a continuing safety-reporting duty — which belongs in the pharmacovigilance agreement and the vendor scope, since trial safety infrastructure is often being wound down at exactly the point PTA begins.

Stability of the pathway

Título X has not been amended. Decreto Supremo N.° 028-2023-SA of 17 October 2023 modified numeral 2.1 item 10 of Article 2, Article 34(b), Article 40(b), Article 52(e), the heading of Chapter III of Título V, Anexo 1 and Anexo 4, and incorporated items 2.1.48 and 2.1.49, a third paragraph to Article 6, Article 60(i), and new Articles 85-A and 85-B. Articles 115 through 118 are not among them. The pathway a sponsor plans against today is the pathway approved in DS 021-2017-SA of 28 June 2017.

Working on a LATAM post-trial access program? bioaccess® is a US-headquartered, LATAM-native operator running regulatory, importadora, and 2–8 °C GDP cold-chain functions directly across the region. If you’re evaluating PTA feasibility in Peru, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

Frequently asked questions

Does Peru require post-trial access?
Yes. Título X of the Reglamento de Ensayos Clínicos, approved by Decreto Supremo N.° 021-2017-SA, creates a binding post-study access duty. Article 115 defines it as free availability of the investigational product to the research subject after the study closes or after that subject’s participation ends, and Article 40(p) assigns the duty to the sponsor. The obligation is conditional rather than automatic: Article 115 requires the principal investigator to find the product beneficial for that subject, and weighs the seriousness of the condition, the effect of withdrawal, the absence of satisfactory alternatives in Peru, the available efficacy and safety data, and the benefit-risk balance.

What is Decreto Supremo 021-2017-SA?
It is the Peruvian Reglamento de Ensayos Clínicos, dated 28 June 2017, the decree that governs authorization and conduct of clinical trials in Peru. It sets sponsor and investigator responsibilities, ethics committee accreditation, OGITT trial authorization, investigational product controls, import, pharmacovigilance and supervision. Título X (Articles 115–118) is its post-study access chapter. It was amended by Decreto Supremo N.° 028-2023-SA of 17 October 2023, which did not touch Articles 115–118.

Who pays for post-trial supply in Peru?
The sponsor, entirely. Article 89 requires that investigational products be financed by the sponsor and provided free of charge to the research subject, and Article 115 describes post-study access itself as “disponibilidad gratuita.” Article 40(p) puts the access obligation on the sponsor and requires that it be disclosed in the informed consent form. There is no cost-sharing, reimbursement or named-patient sale construct available. Sponsors should budget product cost, import, storage, dispensing and destruction for the entire period the principal investigator finds benefit continuing.

What are the two authorization routes for PTA in Peru?
Article 116 names them. The first is authorization of a clinical trial constituting an extension study, granted by OGITT at the Instituto Nacional de Salud under the ordinary trial-authorization requirements of Article 67. The second is a case-by-case authorization from the Autoridad Nacional de Productos Farmacéuticos, Dispositivos Médicos y Productos Sanitarios (ANM) for an investigational product that the principal investigator judges beneficial to the subject. Under Article 116, the investigator notifies the sponsor and the sponsor files the ANM application.

What is the 7-document checklist under Article 117?
For the ANM route, Article 117 requires: (a) an application addressed to the ANM; (b) written informed consent signed by the subject or legal representative and the principal investigator; (c) a clinical report in which the principal investigator justifies the need for treatment; (d) a duly completed official medical prescription; (e) agreement from the person responsible for the institution where treatment will be applied; (f) an updated investigator’s brochure as applicable; and (g) a copy of the resolución directoral authorizing the trial from which the case derives. Authorization is granted case by case.

Does Peru PTA apply to medical devices?
Yes, textually. Article 2, numeral 2.1, item 36 defines “producto en investigación” as a pharmaceutical product or medical device investigated or used as a comparator in a clinical trial, referencing Ley N.° 29459 for both terms. Título X operates on that same defined term, so the post-study access duty reaches device trials. The Reglamento contains no device-specific exemption from Articles 115–118, which means MedTech sponsors should model continued availability of the device system and its consumables in the same way drug sponsors model continued dosing.

How long does OGITT authorization take?
Article 70 gives OGITT a maximum of 40 business days to issue the resolution authorizing a clinical trial, inclusive of the 30 business days Article 69 allows the ANM for its binding technical opinion on the investigational product’s safety and quality. For biologic investigational products, or where the INS convenes technical commissions for controversial matters, the maximum is 60 business days, inclusive of a 45-business-day ANM opinion. The clock is suspended while the applicant responds to a request for supplementary information, so these are clean-file maxima rather than expected durations.

How long does DIGEMID/ANM case-by-case authorization take?
The Reglamento does not state a review period for the Article 116–117 case-by-case authorization. It does set an adjacent deadline that is often confused with it: under Article 94, the ANM must issue the investigational product import authorization by resolución directoral within three business days of application. Sponsors should confirm the expected case-review duration with the ANM for the specific product and patient rather than planning against a published figure, and should not assume the three-day import period applies to the Article 117 dossier.

What is the difference between OGITT and DIGEMID in Peru PTA?
OGITT — the Oficina General de Investigación y Transferencia Tecnológica of the Instituto Nacional de Salud — authorizes and supervises clinical trials, including the extension trial that constitutes Route 1 under Article 116. DIGEMID acts as the ANM: it issues binding technical opinions on investigational product safety and quality (Article 69), authorizes importation (Article 94), grants the case-by-case post-study access authorization (Articles 116–117), and receives the post-access safety reports (Article 118). Route 1 is an INS filing; Route 2 is a MINSA medicines-authority filing.

What are the pharmacovigilance obligations during Peru PTA?
Article 118 requires the sponsor to communicate the results of the treatment to the ANM within the established period, together with suspected adverse drug reactions attributable to the product, without prejudice to reporting adverse reactions to the corresponding territorial health authority. This duty runs for the life of the post-study access arrangement, which under Article 115 continues as long as the principal investigator finds benefit. Sponsors should ensure safety case processing, medical monitoring and the local reporting channel survive database lock rather than being decommissioned with the trial.

Sources

September 6, 2026

Post-trial access in Chile under Ley 20.850 and Código Sanitario Art. 111 C
Chile obliges the holder of a clinical trial’s provisional-use authorization — and, later, whoever holds the product’s sanitary registration — to keep supplying the trial treatment free of charge for as long as it retains therapeutic usefulness. The rule is Article 111 C of the Código Sanitario, inserted by Ley 20.850, and it is written in a way that binds an acquirer who was never involved in the trial.

That last clause is why Chile belongs on a deal checklist rather than only on a clinical operations checklist. A US sponsor can sell or out-license a Chilean-registered product and hand the buyer an open-ended, free-of-charge supply duty that appears nowhere in the trial budget, the product P&L, or most representations and warranties.

What Ley 20.850 actually did

Ley Núm. 20.850, “Crea un sistema de protección financiera para diagnósticos y tratamientos de alto costo y rinde homenaje póstumo a don Luis Ricarte Soto Gallegos,” was promulgated on 1 June 2015 by the Ministerio de Salud (BCN Ley Chile) and published in the Diario Oficial on 6 June 2015, a date recited in later ministerial decrees (Decreto 11 Exento, 30 April 2025).

The statute is best known for the high-cost treatment fund it created. But Article 34 of the same law added two new Titles to Book Four of the Código Sanitario: Title V on clinical trials of pharmaceutical products and elements of medical use (Arts. 111 A to 111 G), and Title VI on defective health-product liability (Arts. 111 H to 111 N). Chile’s trial authorization regime, its post-trial access duty, its strict-liability rule for trial injury and its ten-year limitation period all arrived in one act (Código Sanitario, DFL 725). Ley 20.850 restates the same right in Article 17: trial patients “tendrán derecho… a la continuidad gratuita de los tratamientos recibidos conforme al protocolo de estudio, aun cuando éste haya finalizado y mientras subsista su utilidad terapéutica” (Ley 20.850, Art. 17).

What Article 111 C requires

The operative text is short. Article 111 C, first paragraph:

“El paciente sujeto de ensayo clínico tendrá derecho a que, una vez terminado éste, el titular de la autorización especial para uso provisional con fines de investigación y, con posterioridad en su caso, el titular del registro sanitario del producto sanitario de que se trate, le otorgue sin costo para el paciente la continuidad del tratamiento por todo el tiempo que persista su utilidad terapéutica, conforme al protocolo de investigación respectivo.” (Código Sanitario Art. 111 C)

Four things follow. It is a patient right, not a sponsor best-effort. It is free to the patient, with no cost-sharing carve-out. It has no calendar end point: termination turns on loss of therapeutic usefulness, not commercial launch, not reimbursement listing, not a fixed number of years. And it is anchored to the study protocol, so the protocol’s definition of continued benefit stays load-bearing years after database lock. Brazil caps the equivalent duty at five years from commercial availability; Chile has a named obligor and no clock.

Breach is sanctioned under Article 111 G, which routes Title V infractions to Book Ten of the Código Sanitario and to Ley 20.120. Book Ten’s general penalty article allows fines from one-tenth of a UTM up to 1,000 UTM, doubled on recidivism, plus suspension of distribution and use of the products concerned (Código Sanitario, Art. 174).

Devices are expressly in scope

Most Latin American post-trial provisions are drafted around medicines and leave device sponsors to argue about scope. Chile does not. Article 111 A states that the special provisional-use authorization “se requerirá para todo producto farmacéutico o dispositivo médico,” and Title V is titled for “productos farmacéuticos y elementos de uso médico” (Código Sanitario Art. 111 A). Because Article 111 C attaches to the holder of that same authorization, the post-trial duty reaches device sponsors on the face of the text. The Ministerio de Salud may exempt, by supreme decree, device categories whose use “no conlleve un riesgo relevante para las personas” — that is an exemption from the authorization requirement, and a sponsor relying on it should confirm the specific decree rather than assume one exists for its class.

For an implantable or capital-equipment device, continuity “for as long as therapeutic usefulness persists” raises questions the statute does not answer: replacement units, consumables, explant and revision, software maintenance, end of product life. Those gaps close in the protocol and the informed consent, because Article 111 C points back to the protocol for its content.

The obligation follows the registration, not the sponsor

The second paragraph of Article 111 C is the one that changes deal economics:

“Esta obligación afectará al titular del registro sanitario, aun cuando no haya sido el titular de la autorización provisional o haya adquirido con posterioridad el registro sanitario.” (Código Sanitario Art. 111 C)

Read that literally. The duty binds the sanitary-registration holder even where that party never held the provisional-use authorization, and even where it acquired the registration afterwards. It travels with the asset by operation of law. An asset purchase that transfers only the Chilean registration — no trial contracts, no site agreements, no sponsor entity — still carries the tail. A licensing deal in which the licensee becomes the Chilean registration holder does the same.

Four diligence questions follow for anyone buying a product with Chilean clinical history. Was any Chilean trial run under an ISP provisional-use authorization for this product, per the public research register the ISP must keep under Article 111 A? How many participants remain on treatment, under what protocol definition of continued benefit? Who has supplied them since study close, under what import authorization? And is there seller indemnity for a duty Chilean law places on the registration holder directly — noting that allocation between the parties does not extinguish the duty toward the patient.

The exposure is unbounded in duration by design, which makes it hard to reserve for and easy to miss. We identified no published Chilean enforcement decision quantifying the tail, so today’s practical risk is less about fines than about inheriting an undisclosed supply commitment and finding it after closing.

Where the ISP fits

The Instituto de Salud Pública is the regulator on both ends of this obligation. It grants the provisional-use authorization under Article 111 A — valid for no more than one year, renewable for equal successive periods — accredits research centers under Article 111 D, and fiscalizes protocols, informed consents, good clinical practice and adverse-event reporting (Código Sanitario Arts. 111 A and 111 D). Article 111 D also makes any confidentiality obligation in a protocol or agreement unenforceable against the ISP. The authorization is a paid service: prestación 4111035 is listed at CLP $1,129,893 plus IVA (ISP). Article 99 separately lets the ISP provisionally authorize unregistered pharmaceutical products for trials and for urgent medicinal uses arising from shortage or inaccessibility (Código Sanitario Art. 99; ISP guidance).

What the ISP has not published is Article 111 C guidance. Its “Guía de consideraciones generales para estudios clínicos” (Res. Ex. N° 173, 29 January 2024 — BCN) and its first-edition “Guía de investigación clínica de dispositivos médicos en humanos. Buenas prácticas clínicas” (Res. Ex. N° 341, 7 April 2026, recorded as Res. Ex. 2.050 — BCN; ISP) were both reviewed for post-trial content. The device guide cites Article 111 A and covers post-participation care for adverse events and post-market clinical follow-up, but not Article 111 C or continued supply. Chile’s newest device GCP guidance is silent on the obligation its own statute imposes on device sponsors.

CENABAST and the exceptional-import backstop

CENABAST is Chile’s public procurement and supply agency, and Ley 20.850 gave it powers that matter when a supply chain breaks. Under Article 15, where a product covered by the high-cost system has its registration suspended, cancelled or lapsed, CENABAST may — with prior Ministry of Health authorization, and only where no alternative exists at the maximum industrial price — exceptionally import and distribute it “independientemente si cuentan o no con autorización o registro sanitarios.” The same article deems those circumstances public-health grounds under Chile’s industrial property law and closes with a liability rule: “Los titulares de los registros o autorizaciones sanitarias, los productores o los importadores serán responsables civilmente por la falta de continuidad de los tratamientos” (Ley 20.850, Art. 15). Article 31 adds the procurement side: contracting one product with more than one supplier where continuity requires it, direct contracting where CENABAST holds the registration itself, and requesting a provisional sanitary registration in shortage situations (Ley 20.850, Art. 31; CENABAST).

This is a state backstop for continuity of covered treatments, with civil liability pointed back at the registration holder. It is not a route to hand off an Article 111 C duty.

The Ricarte Soto Fund as the exit ramp, and its limits

Ley 20.850’s financial protection system is insured by FONASA for beneficiaries of every Chilean health system — FONASA, isapres, CAPREDENA and DIPRECA — regardless of socioeconomic status, and covers 100% of the cost of the medicines, medical devices or foods expressly guaranteed for each defined health problem (Superintendencia de Salud). ChileAtiende describes it as guaranteeing diagnosis and treatment for 27 high-cost conditions (ChileAtiende). Inclusion runs through a supreme decree under Article 5, subject to a cost threshold, favourable scientific evaluation, recommendation and an incorporation decision (Ley 20.850, Art. 5).

Getting a product into that decree is the cleanest way for Article 111 C exposure to become a state-funded treatment rather than a private supply obligation. It is also slow, competitive and outside the sponsor’s control — and nothing in Article 111 C ends the duty on listing. Treat it as practical mitigation, not a legal termination event.

What the statute leaves open

First, Title V repeatedly refers to a reglamento — adverse-event reporting under Article 111 B, center accreditation under Article 111 D, insurance under Article 111 F. We identified no ISP or MINSAL instrument in this review that operationalizes Article 111 C specifically. The obligation is statutory and self-executing on its face; the mechanics are not written down.

Second, entry into force. The first transitory article provides that “las normas de esta ley regirán a contar de la entrada en vigencia del decreto a que se refiere el artículo 5º” (Ley 20.850, disposiciones transitorias). The Article 34 amendments sit in the consolidated Código Sanitario text and the ISP has operated the Article 111 A authorization since, but how that clause interacts with the Title V insertions is a question for Chilean counsel, not for a CRO.

Third, “utilidad terapéutica” is undefined. Chile’s medical academy, writing on Title V and its draft reglamento in Revista Médica de Chile, argued that continuation should be decided case by case once final results including safety are known, by the patient and treating physician, and that “se necesita una definición de utilidad más objetiva y fácil de determinar” (Rev Med Chile). Until that definition exists, the protocol is the only instrument that sets the endpoint — an argument for drafting it at protocol design, not at study close.

Working on a LATAM post-trial access program? bioaccess® is a US-headquartered, LATAM-native operator running regulatory, importadora, and 2–8 °C GDP cold-chain functions directly across the region. If you’re evaluating PTA feasibility or acquisition exposure in Chile, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

Frequently Asked Questions

Does Chile require post-trial access?
Yes. Article 111 C of the Código Sanitario gives clinical trial participants a right to continued treatment after the trial ends, free of charge, for as long as the treatment retains therapeutic usefulness. The duty falls first on the holder of the ISP special provisional-use authorization and then on the holder of the product’s sanitary registration. The same right is restated in Article 17 of Ley 20.850. This is a statutory patient right, not an ethics-committee expectation or a best-efforts commitment, and breach is sanctionable under Article 111 G through Book Ten of the Código Sanitario.

What is Ley 20.850 (Ley Ricarte Soto)?
Ley 20.850 is the Chilean statute that created a universal financial protection system for high-cost diagnoses and treatments, promulgated 1 June 2015 and published 6 June 2015. It is named in posthumous tribute to journalist Luis Ricarte Soto Gallegos. Beyond the fund, its Article 34 inserted Titles V and VI into Book Four of the Código Sanitario, creating Chile’s clinical trial authorization regime (Arts. 111 A to 111 G) and its defective health-product liability regime (Arts. 111 H to 111 N). Most sponsors know the fund and miss the clinical trial chapter.

What does Código Sanitario Art. 111 C require?
It requires that, once a clinical trial ends, the holder of the special provisional-use authorization — and afterwards, where applicable, the holder of the product’s sanitary registration — provide the participant with continuity of treatment “sin costo para el paciente,” for the whole time that its therapeutic usefulness persists, in accordance with the study protocol. A second paragraph extends the duty to a registration holder that never held the provisional authorization or that acquired the registration later. There is no calendar limit and no cost-sharing exception in the text.

Does Chile PTA apply to medical devices?
Yes, on the face of the statute. Article 111 A states that the special provisional-use authorization is required for “todo producto farmacéutico o dispositivo médico,” and Title V is titled for pharmaceutical products and elements of medical use. Because Article 111 C attaches to the holder of that authorization, device sponsors are captured. The Ministry of Health may exempt low-risk device categories from the authorization requirement by supreme decree, so confirm the applicable decree for your class rather than assuming an exemption applies.

Who pays for post-trial supply in Chile?
The obligated party pays. Article 111 C says the treatment is provided “sin costo para el paciente,” and names the provisional-use authorization holder and then the sanitary-registration holder as the parties who must provide it. There is no provision allowing the cost to be shifted to the patient, the treating institution, FONASA or an isapre. Sponsors may allocate the economics contractually between themselves, a licensee or an acquirer, but that allocation does not change who Chilean law holds responsible to the patient.

How long must sponsors provide post-trial access in Chile?
For as long as therapeutic usefulness persists — “por todo el tiempo que persista su utilidad terapéutica.” Chile sets no fixed term, no five-year cap, and no automatic termination at commercial launch or reimbursement listing. That makes it materially more open-ended than Brazil, where Lei 14.874/2024 permits interruption five years after commercial availability. Because “utilidad terapéutica” is undefined in the statute, the study protocol referenced by Article 111 C becomes the practical instrument that defines when the obligation ends.

What is the M&A diligence trap in Chile PTA?
The second paragraph of Article 111 C binds the sanitary-registration holder “aun cuando no haya sido el titular de la autorización provisional o haya adquirido con posterioridad el registro sanitario.” The supply duty travels with the registration by operation of law. A buyer acquiring only a Chilean marketing authorization — with no trial contracts, no sponsor entity, no site agreements — can inherit an open-ended, free-of-charge obligation to patients it has never seen, arising from a trial it never ran. Standard reps and warranties rarely surface it, and standard product P&Ls never price it.

What is ISP’s role in Chile PTA?
The Instituto de Salud Pública grants the Article 111 A special provisional-use authorization (maximum one year, renewable for equal successive periods), maintains the public register of authorized human research, accredits research centers under Article 111 D, and fiscalizes protocols, informed consents, GCP and adverse-event notification. Its listed fee for prestación 4111035 is CLP $1,129,893 plus IVA. The ISP’s public register is the practical starting point for confirming whether a Chilean-registered product has a trial history that could trigger an Article 111 C tail.

What is CENABAST and how does its exceptional-import route work?
CENABAST is Chile’s Central de Abastecimiento, the public health supply and procurement agency. Under Article 15 of Ley 20.850, where a covered product’s registration is suspended, cancelled or lapsed, CENABAST may — with prior Ministry of Health authorization and where no priced alternative exists — exceptionally import and distribute it regardless of whether it holds sanitary registration, to guarantee treatment continuity. Article 31 lets it contract with multiple suppliers and request a provisional sanitary registration in shortage situations. Article 15 also makes registration holders, producers and importers civilly liable for failures of treatment continuity.

Does the PTA obligation transfer with the marketing authorization?
Yes. That is the explicit effect of Article 111 C’s second paragraph, and it is the single most commercially consequential sentence in Chile’s post-trial regime. Acquirers and in-licensees should treat the Chilean registration as carrying a potential supply liability, diligence the ISP research register and the seller’s Chilean trial history, quantify the number of patients still on treatment, and negotiate indemnities knowing that the statutory duty to the patient sits with whoever holds the registration.

Sources
- Ley Núm. 20.850, Ministerio de Salud, promulgated 1 June 2015 — Arts. 5, 15, 17, 31, 34, disposiciones transitorias: https://www.bcn.cl/leychile/navegar?idNorma=1078148
- Código Sanitario (DFL 725), consolidated text — Arts. 99, 111 A, 111 B, 111 C, 111 D, 111 E, 111 F, 111 G, 111 H–111 N, 174: https://www.bcn.cl/leychile/navegar?idNorma=5595
- Decreto 11 Exento, M. de Salud, 30 April 2025 (recital confirming Ley 20.850 published 6 June 2015): https://www.bcn.cl/leychile/navegar?idNorma=1212845
- ISP prestación 4111035, provisional-use authorization for clinical study products: https://www.ispch.gob.cl/prestacion/4111035/
- ISP, autorización excepcional sin registro sanitario (Art. 99 / D.S. 3/2010 Art. 21, prestación 4111036, SAFIS): https://www.ispch.gob.cl/anamed/medicamentos/autorizacion-excepcional-sin-registro-sanitario/
- ISP, Estudios Clínicos: https://www.ispch.gob.cl/anamed/estudios-clinicos/
- Resolución Exenta N° 173, 29 January 2024, “Guía de consideraciones generales para estudios clínicos” (ISP): https://www.bcn.cl/leychile/navegar?idNorma=1201301
- Resolución Exenta N° 341, 7 April 2026 / Res. Ex. 2.050, “Guía de investigación clínica de dispositivos médicos en humanos. Buenas prácticas clínicas” (ISP): https://www.bcn.cl/leychile/navegar?idNorma=1223885 and https://www.ispch.gob.cl/wp-content/uploads/resoluciones/36444_2050-2026.pdf
- CENABAST, “Ley Ricarte Soto: con nuevas facultades, CENABAST asegura disponibilidad de medicamentos”: https://www.cenabast.cl/ley-ricarte-soto-con-nuevas-facultades-cenabast-asegura-disponibilidad-de-medicamentos/
- Superintendencia de Salud, Ley Ricarte Soto orientation page: https://www.superdesalud.gob.cl/tax-temas-de-orientacion/ley-ricarte-soto-6088/
- ChileAtiende, Ley Ricarte Soto: https://www.chileatiende.gob.cl/fichas/38873-ley-ricarte-soto
- Academia Chilena de Medicina, declaration on Title V of Ley 20.850 and its draft reglamento, Revista Médica de Chile: https://www.scielo.cl/scielo.php?script=sci_arttext&pid=S0034-98872017000300013
September 6, 2026
Post-trial access in Brazil under Lei 14.874/2024 and Decreto 12.651/2025
Brazil is the only Latin American country where free post-trial supply of an investigational product is an explicit, sponsor-funded statutory duty that reaches drugs, medical devices and advanced therapies alike. Brazil’s Ministry of Health puts it plainly: continued treatment after the study “não é uma expectativa, mas um dever legal” — not an expectation, but a legal duty (INAEP FAQ).

The duty has two layers. Lei nº 14.874, de 28 de maio de 2024 — the Marco Legal de Pesquisa Clínica — created it in Chapter VI, Articles 30 to 37, entering into force 90 days after its 29 May 2024 publication under Article 65. Decreto nº 12.651, de 7 de outubro de 2025 supplied the mechanics, taking effect on publication in the Diário Oficial da União of 8 October 2025 under Article 41. Sponsors budgeting a Brazilian trial in 2026 budget against both.

What the statute actually requires

Chapter VI of Lei 14.874/2024 is titled “Da continuidade do tratamento pós-ensaio clínico,” and it front-loads the work. Article 30 requires the sponsor and the investigator, before the trial starts, to submit a plano de acesso pós-estudo to the research ethics committee, justifying whether free post-trial supply will be needed. If it will, Article 30 §1 requires a programa de fornecimento pós-estudo, and §2 requires that program to guarantee continued safety follow-up and receipt of the experimental treatment “por prazo determinado.” Article 30 §3 adds a scheduling constraint sponsors routinely miss: the program may only begin after regulatory approval, and the request must be filed early enough for participants to transition without a treatment gap.

At the end of the trial, Article 31 requires an individual assessment for each participant, performed by the investigator with the sponsor and the participant heard. Under Article 31 §2, free supply is triggered whenever the investigational product is the best therapy for that participant’s condition and shows a more favorable risk-benefit ratio than available alternatives. Article 32 sets the four criteria: disease severity, availability of satisfactory alternatives in the participant’s locality, whether the product addresses an unmet clinical need, and whether evidence of benefit exceeds evidence of risk. Article 31 §3 and Article 34 §2 both provide that the participant “deverá migrar automaticamente” into the post-study program — migration is automatic, not opt-in.

Article 31 of the Decreto: the operative sentence

Decreto 12.651/2025 Article 31 states the duty in the language sponsors should quote in their own SOPs: the sponsor, after the trial ends, “deverá garantir aos participantes da pesquisa o fornecimento gratuito do produto sob investigação sempre que este for considerado pelo pesquisador responsável como a melhor alternativa terapêutica para a condição clínica do participante, com base em evidências disponíveis e em avaliação favorável da relação risco-benefício.”

Two details matter. First, the decree says produto sob investigação — investigational product — not medicamento. Second, Article 31 §1 requires the program to be drafted by the sponsor and submitted to the competent CEP, and to contain the supply strategy for the period after individual participation ends. Article 31 §2 reserves the detailed guidelines to a future norm from the Instância Nacional de Ética em Pesquisa.

Brazil’s Ministry of Health has already closed the obvious loophole. Asked whether the program can simply be notified, the INAEP FAQ answers: “Deve ser submetido para avaliação do CEP competente. Não basta notificar” (INAEP FAQ on submission). Pending the INAEP norm, the same page recommends a minimum submission package: program description, technical and risk-benefit justification, inclusion and maintenance criteria, a participant safety follow-up plan, expected supply duration and termination conditions under Article 33, allocation of sponsor, investigator and institution responsibilities, care-transition strategy, and whether ANVISA authorization is required.

Who pays, and for how long

Cost allocation is unambiguous. Lei 14.874/2024 Article 31 §4 states that where continued treatment with the experimental drug is necessary after trial end, “o fornecimento do medicamento será de responsabilidade do patrocinador.” Article 34 §1 repeats that the sponsor guarantees free post-trial supply, and Decreto 12.651/2025 Article 31 says fornecimento gratuito. ANVISA’s own RDC nº 38, de 12 de agosto de 2013 Article 18 assigns the sponsor complete free treatment (inciso I), product custody and storage (II), a bar on commercializing the product (III), and funding of integral assistance for complications arising from its use (VI). Article 35 §2 of the statute separately makes the sponsor responsible for care needed because of study-caused reactions.

Duration is where Brazil diverges from every other regime in the region. Article 33 permits interruption only on seven grounds, each requiring a justification submitted to the CEP: participant decision, cure or introduction of a satisfactory alternative, absence of continued benefit, a disqualifying adverse reaction, technical or safety impossibility of manufacture (provided the sponsor supplies an equivalent or better marketed alternative), inciso VI “transcurso do prazo de 5 (cinco) anos, contado da disponibilidade comercial do medicamento experimental no País,” and inciso VII availability in the public health network.

Inciso VI carries visible veto history: the Planalto text shows “VI – (VETADO)” immediately followed by the five-year text marked “(Promulgação partes vetadas)” — the vetoed passage was subsequently promulgated. The practical effect is that the five-year clock only starts when the product becomes commercially available in Brazil. A sponsor that never commercializes there, or commercializes late, has no five-year backstop running in its favor. The exposure terminates on clinical or supply events, not on a date fixed at trial close.

Devices and advanced therapies are in scope

Article 37 of Lei 14.874/2024 is one sentence, and it is why MedTech and cell-and-gene sponsors cannot treat this as a pharma-only issue: “Aplicar-se-ão aos produtos e dispositivos médicos e aos produtos de terapias avançadas experimentais, objeto de ensaio clínico, as disposições deste Capítulo, no que couber.” The whole post-trial chapter applies to medical devices and experimental advanced therapy products, insofar as applicable. Decreto 12.651/2025 Article 31 reinforces this by using produto sob investigação.

The caveat is operational, not legal: RDC 38/2013 was written in 2013 and speaks only of medicamento. ANVISA maintains a separate service channel for advanced-therapy product programs, but there is no equivalent device-specific post-study petition. For an implantable or an active device, the statutory duty exists while the import and dispensing pathway has to be built from the trial’s own authorization documents — a problem to solve in the protocol, not at trial close.

CEP, ANVISA and INAEP: three approvals, three functions

Lei 14.874/2024 Article 5 splits Brazil’s Sistema Nacional de Ética em Pesquisa into a national ethics instance and the CEPs. In post-trial access, the division of labor is:
- CEP — approves the pre-trial plan (Art. 30), the post-study program (Decreto Art. 31 §1), and any interruption justification (Art. 33). The INAEP FAQ states this is, as a rule, the coordinating centre’s CEP.
- ANVISA — Article 34 §3 requires that importation and dispensing during the post-study program be previously authorized by the competent sanitary authority.
- INAEP — the Instância Nacional de Ética em Pesquisa issues ethics norms, credentials and accredits CEPs, and acts as appellate instance over CEP decisions (Art. 8). Decreto Article 31 §2 assigns it the post-study guidelines.
INAEP became operational during 2026. It adopted its internal regulation by Resolução nº 1 of 2 April 2026 and transitional CEP accreditation procedures by Resolução RCI nº 2 of 8 May 2026 (INAEP legislation index), and held its first ordinary meeting with full membership in Brasília on 14 August 2026, seating 15 titular and 15 alternate members from the scientific community alongside representatives of ANVISA, the Conselho Nacional de Saúde and three ministries (Ministério da Saúde). No post-study-specific INAEP norm appears in its legislation index yet. Two transitional rules still shape practice: Decreto Article 39 keeps Conselho Nacional de Saúde norms valid until INAEP replaces them, and Article 40 keeps CONEP as the appellate instance until INAEP’s members are seated.

The import mechanism

For medicines, RDC 38/2013 is still the operative instrument — ANVISA’s own programas assistenciais page lists post-study supply as one of three assistance programs under it. The sequence:
1. The sponsor or a contracted organização representativa do patrocinador (ORP) files the anuência request with ANVISA (Art. 4).
2. For post-study supply specifically, ANVISA does not issue a comunicado especial. Article 3 §2 provides that it issues “um ofício autorizando o fornecimento.”
3. The import licence (LI) is filed on the RDC 39/2008 form and, per Article 16 parágrafo único, may be filed together with the anuência process.
4. The dossier per Anexo I §IV is the Anexo IV petition form, the sponsor’s Anexo VI commitment declaration, the physician’s Anexo VII declaration, the physician’s CV, the Anexo VIII import quantity estimate, and the comunicado especial that authorized the trial.
5. Post-anuência, imports follow the trial’s own comunicado especial or import document, and under Orientação de Serviço nº 01/2020 no pre-shipment authorization is required.
6. Reporting continues: annual reports from the date of anuência, a final report within 90 days of program close, discontinuation notice within 60 days, and serious adverse event notification within 15 calendar days, or 7 in case of death (Arts. 17 and 18).
On timing, ANVISA’s service pages state an average of 20 calendar days for the medicines and biologics post-study petition service and 10 calendar days for advanced therapies. Those are service-level averages, not statutory deadlines — RDC 38/2013 sets no analysis period. Treat the CEP submission and the ANVISA filing as parallel critical-path items.

One watch item: ANVISA Consulta Pública nº 1.210/2023 proposed a risk-based revision of RDC 38/2013 allowing the post-study program to proceed by notification. Comments closed 2 January 2024 and the revision has not been finalized. The same notice disclosed that between 2019 and 2023 ANVISA received 256 post-study supply requests, alongside 558 compassionate use and 41 expanded access requests.

What this means for a sponsor’s budget

Brazil converts post-trial access from an ethics-committee expectation into a balance-sheet item with an indeterminate end date. The cost driver is not the product; it is the tail — free supply, cold-chain distribution, pharmacovigilance, ANVISA reporting and CEP maintenance running until one of seven Article 33 events occurs, with the five-year clock not starting until Brazilian commercial availability. Price that tail in the Article 30 pre-trial plan, decide in the protocol how a device or advanced therapy will physically be imported and dispensed post-close, and treat the eventual INAEP norm under Decreto Article 31 §2 as a change-control trigger.

Working on a LATAM post-trial access program? bioaccess® is a US-headquartered, LATAM-native operator running regulatory, importadora, and 2–8 °C GDP cold-chain functions directly across the region. If you’re evaluating PTA feasibility in Brazil or elsewhere in Latin America, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

Frequently asked questions

Does Brazil require post-trial access?
Yes, as a matter of statute. Lei 14.874/2024 Chapter VI (Arts. 30–37) and Decreto 12.651/2025 Article 31 require the sponsor to guarantee free continued supply of the investigational product to participants whenever the responsible investigator considers it the best therapeutic alternative for that participant’s clinical condition and the risk-benefit assessment is favorable. Brazil’s Ministry of Health describes this as “não é uma expectativa, mas um dever legal.” The obligation begins before the trial does: Article 30 requires a post-study access plan to be filed with the research ethics committee before enrollment starts.

What is Lei 14.874/2024?
Lei nº 14.874 of 28 May 2024 is Brazil’s Marco Legal de Pesquisa Clínica, the statute governing research with human subjects. It created the Sistema Nacional de Ética em Pesquisa com Seres Humanos, split into a national ethics instance and the CEPs, and devoted Chapter VI to continuity of treatment after the clinical trial. It entered into force 90 days after its 29 May 2024 official publication under Article 65. Its post-trial provisions replaced a regime that previously rested largely on Conselho Nacional de Saúde resolutions.

What is Decreto 12.651/2025?
Decreto nº 12.651 of 7 October 2025 is the implementing decree for Lei 14.874/2024. It took effect on publication in the Diário Oficial da União of 8 October 2025 under Article 41. Article 31 restates the sponsor’s free-supply duty using the broader phrase produto sob investigação, requires the sponsor to draft the post-study access program and submit it to the competent CEP with its supply strategy, and reserves detailed elaboration and review guidelines to a future INAEP norm. Articles 39 and 40 set transitional rules preserving CNS norms and CONEP’s appellate role.

Who pays for post-trial supply in Brazil?
The sponsor, exclusively and free of charge to the participant. Lei 14.874/2024 Article 31 §4 provides that supply of the medicine is the sponsor’s responsibility; Article 34 §1 requires the sponsor to guarantee free post-trial supply; and Decreto 12.651/2025 Article 31 uses fornecimento gratuito. RDC 38/2013 Article 18 adds that the sponsor must fund complete free treatment, keep the product properly stored, refrain from commercializing it, and fund integral assistance for complications arising from its use. Article 35 §2 of the statute separately covers care for study-caused reactions.

How long must sponsors provide post-trial access in Brazil?
There is no fixed end date. Lei 14.874/2024 Article 33 allows interruption only on seven grounds, each requiring justification submitted to the CEP: participant decision, cure or a satisfactory alternative, absence of continued benefit, a disqualifying adverse reaction, technical or safety impossibility of manufacture with an equivalent alternative supplied, five years counted from commercial availability in Brazil, or availability in the public health network. Because the five-year clock starts at Brazilian commercial availability rather than trial close, the practical tail is the longest in Latin America.

Does Brazil PTA apply to medical devices?
Yes. Article 37 of Lei 14.874/2024 extends the entire post-trial chapter to produtos e dispositivos médicos used in clinical trials, insofar as applicable, and Decreto 12.651/2025 Article 31 speaks of the investigational product rather than the medicine. The operational gap is that ANVISA’s RDC 38/2013 assistance-program framework addresses medicamento only, so device sponsors have a clear statutory duty but must build the post-close import and dispensing route from the trial’s own authorization documents. Resolve this in the protocol, not at close-out.

Does Brazil PTA apply to advanced therapy medicinal products (ATMPs)?
Yes. Article 37 names produtos de terapias avançadas experimentais alongside devices, so the post-trial chapter applies to cell, gene and tissue-engineered investigational products insofar as applicable. Unlike devices, ATMPs have a dedicated ANVISA service channel for compassionate use, expanded access and post-study supply of advanced therapy products, for which ANVISA states an average service time of 10 calendar days. Lei 14.874/2024 Article 28 §2 separately requires that import and export of experimental advanced therapies be authorized under specific regulation.

What is INAEP and what role does it play?
INAEP is the Instância Nacional de Ética em Pesquisa, the national ethics instance created by Lei 14.874/2024 Article 5 and structured by Decreto 12.651/2025. Under Article 8 of the statute it issues research ethics norms, credentials and accredits CEPs, monitors and inspects them, and serves as appellate instance over CEP decisions. For post-trial access specifically, Decreto Article 31 §2 assigns INAEP the complementary guidelines for preparing, presenting and ethically reviewing the post-study plan and program. INAEP adopted its internal regulation on 2 April 2026 and held its first full-membership ordinary meeting on 14 August 2026.

What is the import mechanism for post-trial supply in Brazil?
For medicines, ANVISA RDC 38/2013. The sponsor or a contracted ORP files an anuência request; for post-study supply ANVISA issues not a comunicado especial but “um ofício autorizando o fornecimento” (Art. 3 §2). The import licence is filed on the RDC 39/2008 form and may be submitted together with the anuência process (Art. 16). The Anexo I §IV dossier comprises the Anexo IV petition, the sponsor’s Anexo VI and physician’s Anexo VII declarations, the physician’s CV, the Anexo VIII quantity estimate, and the trial’s comunicado especial. Lei 14.874/2024 Article 34 §3 makes this prior authorization mandatory.

How does Brazil’s 5-year commercial-availability tail work in practice?
Article 33 inciso VI permits interruption after “transcurso do prazo de 5 (cinco) anos, contado da disponibilidade comercial do medicamento experimental no País.” The trigger is Brazilian commercial availability, not trial completion, marketing authorization elsewhere, or first commercial sale in another market. A sponsor that obtains ANVISA registration but delays Brazilian launch delays the start of its own five-year clock. Sponsors that never commercialize in Brazil cannot rely on inciso VI at all and must exit through one of the other six grounds, each of which requires a CEP-reviewed justification.

Sources
- Lei nº 14.874, de 28 de maio de 2024 (Marco Legal de Pesquisa Clínica), Arts. 5, 8, 28, 30–37, 65 — https://www.planalto.gov.br/ccivil_03/_ato2023-2026/2024/lei/l14874.htm
- Decreto nº 12.651, de 7 de outubro de 2025, Arts. 3, 30–31, 39–41 — https://www2.camara.leg.br/legin/fed/decret/2025/decreto-12651-7-outubro-2025-798105-publicacaooriginal-176652-pe.html
- ANVISA RDC nº 38, de 12 de agosto de 2013, Arts. 1–4, 15–18, 26, Anexo I §IV — https://anvisalegis.datalegis.net/action/ActionDatalegis.php?acao=abrirTextoAto&tipo=RDC&numeroAto=00000038&seqAto=000&valorAno=2013&orgao=RDC/DC/ANVISA/MS&codTipo=&desItem=&desItemFim=&cod_menu=1696&cod_modulo=134&pesquisa=true
- Ministério da Saúde / INAEP FAQ, “O acesso (fornecimento) pós-estudo é opcional? Como a regra funciona?” (20 Feb 2026) — https://www.gov.br/saude/pt-br/composicao/orgaos-colegiados/inaep/faq/faq/acesso-pos-estudo/o-acesso-fornecimento-pos-estudo-e
- Ministério da Saúde / INAEP FAQ, “O programa de acesso pós-estudo deve ser submetido para aprovação ou basta notificar?” (20 Feb 2026) — https://www.gov.br/saude/pt-br/composicao/orgaos-colegiados/inaep/faq/faq/acesso-pos-estudo/o-programa-de-acesso-pos-estudo
- Ministério da Saúde / INAEP, Legislação (Resolução nº 1 of 2 Apr 2026; Resolução RCI nº 2 of 8 May 2026) — https://www.gov.br/saude/pt-br/composicao/orgaos-colegiados/inaep/legislacao
- Ministério da Saúde, “Inaep amplia colegiado com especialistas de diferentes regiões do Brasil” (18 Aug 2026) — https://www.gov.br/saude/pt-br/assuntos/noticias-ms/2026/agosto/inaep-amplia-colegiado-com-especialistas-de-diferentes-regioes-do-brasil
- ANVISA, Programas assistenciais (RDC 38/2013 programs; Orientação de Serviço nº 01/2020) — https://www.gov.br/anvisa/pt-br/assuntos/medicamentos/pesquisaclinica/programas-assistenciais
- gov.br service, “Solicitar autorização para uso compassivo, acesso expandido e fornecimento de medicamentos e produtos biológicos pós-estudo” — https://www.gov.br/pt-br/servicos/solicitar-autorizacao-para-uso-compassivo-acesso-expandido-e-fornecimento-de-medicamentos-e-produtos-biologicos-pos-estudo
- gov.br service, “Solicitar autorização para uso compassivo, acesso expandido e fornecimento de produtos de terapias avançadas” — https://www.gov.br/pt-br/servicos/solicitar-autorizacao-para-uso-compassivo-acesso-expandido-e-fornecimento-de-produtos-de-terapias-avancadas
- ANVISA, “Anvisa abre consulta pública sobre programas assistenciais” (Consulta Pública nº 1.210/2023) — https://www.gov.br/anvisa/pt-br/assuntos/noticias-anvisa/2023/anvisa-abre-consulta-publica-sobre-programas-assistenciais
September 6, 2026
Post-trial access in Argentina under ANMAT Disposición 12792/2016
Argentina obliges sponsors to keep supplying a beneficial investigational product after a trial closes, and it gives that obligation a dedicated import procedure: ANMAT Disposición 12792/2016, the “Procedimiento para la solicitud de importación de la medicación/tratamiento y materiales para el acceso post-estudio.” The filing must be made before the study ends, and it is authorized per investigator and center for twelve months at a time.

Most sponsors discover this instrument late — usually when a site asks who will pay for continued supply after last-patient-last-visit, by which point the filing window has closed. This page sets out what Disposición 12792/2016 requires, what it does not cover, and what changed when Argentina reset its GCP framework on 1 December 2025.

The obligation and the import route live in two different instruments

Argentina splits post-trial access (PTA) across a substantive duty and a procedural route.

The substantive duty is ethical-regulatory. The recitals of Disposición 12792/2016 quote Ministry of Health Resolución 1480/2011, section A9, which states that in industry-sponsored trials where an investigational product has been shown to be beneficial, “el patrocinador deberá continuar su provisión a los participantes hasta que su acceso se garantice por otro medio.” The same recitals cite Código Civil y Comercial Article 58(j), which permits human research only where participants are assured “la disponibilidad y accesibilidad a los tratamientos que la investigación haya demostrado beneficiosos.” That is statutory, not guidance.

The procedural route is Disposición 12792/2016 itself. Article 1 establishes it as the import procedure for post-study medication, treatment and materials for participants in an ANMAT-authorized clinical pharmacology study. Article 8 put it in force the day after its 17 November 2016 publication. It has not been repealed.

What Disposición 12792/2016 covers — and what it excludes

Article 2 is the first thing to read. Authorized extension studies are expressly excluded; they are governed by the trial framework and the terms of their own authorization. If your continuation plan is an open-label extension protocol, you are not filing under 12792/2016.

Scope of goods is broader than “drug.” Article 3(f) covers the products and “los materiales,” and requires that neither differ from what was used in the approved study. The phrase “dispositivo médico” does not appear anywhere in the text, so device sponsors should treat coverage as inferential and confirm it with ANMAT.

The Article 3 dossier: eight documents, filed before study close

Article 3 requires the sponsor to submit, previo a la finalización del estudio:
- (a) A note identifying the participating health centers and a list of candidate patients for continued investigational therapy, with identity kept confidential; the final list of patients actually included is filed later under the same safeguards.
- (b) The general patient informed consent form for post-study access, approved by the CEI of the treating institution.
- (c) A copy of the disposición authorizing the clinical study, plus the approval records for the relevant centers.
- (d) The opinion (dictamen) of the CEI for that center approving the access plan — and that same CEI then follows the plan.
- (e) Authorization from the center’s responsible medical director and a letter of acceptance from the investigator.
- (f) Product detail: lot number, expiry date, and quantities to be authorized to the sponsor for import, plus the materials. Products and materials must not differ from those used in the approved study.
- (g) A sponsor declaration guaranteeing that supply of the medication/treatment and materials will be at no cost to the participant, the treating institution, or the participant’s health coverage.
- (h) Habilitación of the location designated for storage of the product to be imported.
Two of these drive most of the schedule risk. Article 3(d)/(e) are per-center documents — a CEI dictamen, a medical director authorization, and an investigator acceptance letter for every site you intend to keep supplying. Article 3(g) is the cost allocation: the sponsor’s declaration extends free-of-charge supply to three distinct parties, including the obra social or prepaga carrying the participant’s coverage. There is no cost-sharing construction available.

Article 3(h) and the habilitación question

Article 3(h) requires habilitación evidence for “el lugar designado para el almacenamiento del producto a importar.” The text names one designated storage location, singular, and does not itself resolve which location that is. In practice two architectures are used, and the choice should be made before the dossier is assembled rather than after:
- Central depósito. Cohort product is imported into a single ANMAT-habilitada depósito and released to sites against per-patient prescriptions. One habilitación certificate satisfies Article 3(h) for the whole cohort; site-level storage becomes a distribution-and-temperature-control question rather than a filing question.
- Per-site storage. Product is imported to each investigator pharmacy. Each of those locations then needs its own habilitación evidence, and every one of them is a document that can hold up the submission.
For a cohort of 40 to 60 participants across three to five centers, the central-depósito architecture is usually the shorter path, because it decouples the Article 3(h) evidence from site-by-site pharmacy documentation that sponsors do not control.

Article 4: twelve months, per investigator and center

Article 4 assigns the review to ANMAT’s Dirección de Evaluación y Registro de Medicamentos (DERM), which verifies the submitted documentation and either authorizes or rejects the import request “en el/los centros a cargo del investigador respectivo,” stating that the authorization “tendrá vigencia por doce meses a partir de la fecha de aprobación del trámite.”

Three consequences follow. The authorization is scoped to the investigator and center, so adding a site later is a new filing rather than an amendment note. It expires twelve months from approval, so any PTA program expected to run longer than a year needs a continuation submission calendar built from day one, with each center’s clock tracked separately. And because Article 3(a) requires the final list of included patients to be filed “oportunamente,” the cohort list itself is a living document.

Article 6 sits alongside this: the sponsor must report every serious and unexpected adverse drug reaction (RAM-SI) related to product imported under this procedure, by separate expediente, cross-referencing both the study authorization and the post-study supply authorization.

Article 5: how the product physically enters

Article 5 routes physical importation of the Article 3(f) products through the Departamento de Comercio Exterior del INAME. Article 7 makes Resolución Conjunta 942/2001 and 426/2001 applicable.

The importer of record matters. ANMAT’s expanded-access instrument, Disposición 828/2017, establishes that laboratories habilitadas by ANMAT as importers and/or manufacturers of especialidades medicinales are the entities that may request expanded-access program authorization, and Article 4(a) requires a copy of that habilitación in the dossier. The same logic governs PTA operations: a foreign sponsor without an Argentine habilitación cannot be the importer. That role is filled by an ANMAT-habilitada operating partner engaged directly by bioaccess® acting as importadora and depósito, with the sponsor retaining the regulatory filing.

What this route is not: RAEM and expanded access

Sponsors are routinely pointed at Disposición 4616/2019, the Régimen de Accesibilidad de Excepción a Medicamentos (RAEM). It is not a post-trial access instrument and contains no reference to clinical trials. It is an individual-patient exceptional import regime, and three of its features make it unusable for a cohort:
- Article 2(a) applies to medicines not registered with ANMAT but registered in a country listed in Anexo I of Decreto 150/92, “destinados a tratar un paciente en particular.” An unapproved investigational product has no such registration.
- Article 4(a) makes the patient (or a family member or legal representative) the responsible filer, on a treating physician’s prescription, and expressly prohibits “la participación de cualquier tipo de gestor o intermediario.” A sponsor cannot file.
- Article 12 gives the authorization 90 days of validity before Customs (AFIP-DGA); Article 5 caps quantities at 90 days of treatment for short courses and all oncology, 180 days otherwise.
RAEM is fast — Article 10 promises a decision within 10 business days for first-time filings and 3 for continuity — but it is a per-patient instrument for registered-elsewhere products. Disposición 12792/2016 is the sponsor-filed cohort route.

What changed on 1 December 2025

Disposición 7516/2025 rebuilt Argentina’s GCP base. Article 3 adopts ICH E6(R3) for registration-purpose clinical trials, to be complemented by local requirements in Anexo II. Article 7 is a completed repeal: “Deróganse las Disposiciones ANMAT Nros. 6677/10, 4008/17, 9929/19 y 2172/25 y las Circulares Nros. 0001/11 y 004/18 y la Circular del 10 de junio de 2024.” Article 8 set entry into force at 1 December 2025 and provided that filings pending on that date are resolved under the repealed norms.

Two points sponsors keep getting wrong. First, Disposición 12792/2016 is not in the Article 7 repeal list and remains the operative cohort import route; the substantive PTA duty formerly at Disp. 6677/10 numeral 6.8 was carried into the Anexo II local-requirements annex, which is the part of 7516/2025 published only in the BORA web edition and which we have so far read in secondary reproduction rather than from the official annex file. Second, Article 5 of 7516/2025 assigns clinical-study authorization and oversight competences to the Dirección de Investigación Clínica y Gestión del Registro de Medicamentos, including, at 5(e), intervening “a través de Comercio Exterior” to authorize entry or exit of study materials. Disposición 12792/2016 Article 4 still names DERM. Sponsors filing today should expect to confirm the receiving unit with ANMAT rather than rely on the 2016 article text.

Data protection for the follow-up data

PTA generates follow-up safety and dispensing records that usually flow to a sponsor or vendor outside Argentina. That is governed by Ley 25.326 Article 12 and its Decreto 1558/01. Disposición 60-E/2016 Article 1 approves model international transfer clauses — Anexo I for data assignment, Anexo II for service provision — for transfers destined to countries without adequate legislation. Article 3 lists the adequate jurisdictions: EU and EEA members, Switzerland, Guernsey, Jersey, Isle of Man, Faroe Islands, Canada (private sector only), Andorra, New Zealand, Uruguay, and Israel (automated processing only). The United States is not on that list. Article 2 requires that contracts departing from the approved models be submitted for approval within 30 calendar days of signature. An Argentina-to-US PTA data flow therefore needs the model clauses executed, not asserted.

Timeline reality

The Article 3 dossier is not hard to write; it is hard to assemble, because most of the eight items originate outside the sponsor’s organization — CEI dictámenes, medical director authorizations, investigator acceptance letters, and the habilitación certificate. Our planning assumption is four to six weeks from a complete evidence pack to a first ANMAT submission, which is an operator estimate, not a regulatory deadline. The binding constraint is Article 3’s requirement to file before the study ends, so site-document collection has to start while the trial is still running.

Frequently asked questions

Does Argentina require post-trial access?
Yes. The duty is grounded in Código Civil y Comercial Article 58(j), which allows human research only where participants are assured availability of and access to treatments the research has shown beneficial, and it is elaborated in Ministry of Health Resolución 1480/2011 section A9, both quoted in the recitals of ANMAT Disposición 12792/2016. Argentina also gives the duty an operating procedure — a dedicated post-study import authorization — which distinguishes it from jurisdictions that state an obligation without providing a route to fulfil it.

What is ANMAT Disposición 12792/2016?
It is the procedure for requesting import of post-study medication, treatment and materials for participants in an ANMAT-authorized clinical pharmacology study, published 17 November 2016 and in force since the following day. Article 1 establishes the procedure, Article 3 lists the eight documents the sponsor must file before the study ends, Article 4 gives DERM the authorization decision with twelve-month validity per investigator and center, and Article 5 routes physical importation through the Departamento de Comercio Exterior del INAME.

What is the difference between Disp. 12792/2016 and Disp. 4616/2019 (RAEM)?
Disposición 12792/2016 is a sponsor-filed cohort route for post-study continuation of an investigational product. Disposición 4616/2019 approves the Régimen de Accesibilidad de Excepción a Medicamentos, an individual-patient exceptional import regime that makes no reference to clinical trials. RAEM Article 2(a) requires the product to be registered in an Anexo I country under Decreto 150/92, Article 4(a) makes the patient the filer and prohibits any gestor or intermediary, and Article 12 limits authorization validity to 90 days before Customs. RAEM cannot carry a sponsor cohort.

Who must file the Article 3 dossier?
Article 3 places the obligation on “el patrocinador” — the sponsor. The filing is the sponsor’s, not the site’s and not the CEI’s, although Article 3(d) and (e) mean the dossier cannot be completed without the center’s ethics committee dictamen, the medical director’s authorization, and the investigator’s letter of acceptance. Article 6 likewise puts the RAM-SI reporting duty for imported post-study product on the sponsor, by separate expediente.

What are the eight documents required under Article 3?
(a) a note naming participating centers plus a confidentiality-preserving candidate patient list, with the final included-patient list filed later; (b) the CEI-approved general informed consent form; (c) a copy of the study authorization disposición and center approval records; (d) the center CEI’s dictamen approving the access plan; (e) the medical director’s authorization and the investigator’s acceptance letter; (f) product and materials detail with lot, expiry and quantities, not differing from the approved study; (g) the sponsor’s free-of-charge declaration; (h) habilitación of the designated storage location.

How long does ANMAT authorization last per center?
Twelve months. Article 4 states the authorization “tendrá vigencia por doce meses a partir de la fecha de aprobación del trámite,” and it is granted for the centers under the respective investigator’s charge. A program running longer than a year needs a continuation submission per center, tracked on that center’s own approval date rather than on a single program-wide clock. Adding a center mid-program is a fresh authorization, not an administrative note.

Does the sponsor pay for post-trial supply in Argentina?
Yes, and the declaration is part of the dossier. Article 3(g) requires the sponsor to guarantee that provision of the medication, treatment and materials will be “sin costo alguno para el participante, el establecimiento asistencial o su cobertura de salud.” That covers three parties: the participant, the treating institution, and the participant’s health coverage entity. There is no mechanism in the disposición for splitting cost with a site, an obra social, or a prepaga.

How did Disp. 7516/2025 affect the PTA framework?
Disposición 7516/2025 took effect 1 December 2025, adopted ICH E6(R3) at Article 3, and at Article 7 repealed Disposiciones 6677/10, 4008/17, 9929/19 and 2172/25 together with Circulares 0001/11 and 004/18 and the 10 June 2024 Circular. Disposición 12792/2016 is not in that repeal list and remains the cohort import route. The substantive post-trial duty previously at Disp. 6677/10 numeral 6.8 moved into the Anexo II local-requirements annex. Article 8 provides that filings pending on 1 December 2025 are resolved under the repealed norms.

Can a foreign sponsor file directly, or must a local regulatory agent file?
The Article 3 filing is the sponsor’s, and Disposición 12792/2016 does not require a local filer. Physical importation is the constraint. Article 5 routes it through the Departamento de Comercio Exterior del INAME, and ANMAT’s expanded-access instrument Disposición 828/2017 Article 1 confirms that the entities able to act as importers of especialidades medicinales are laboratories habilitadas by ANMAT, with Article 4(a) requiring the habilitación certificate in the dossier. A foreign sponsor therefore needs an ANMAT-habilitada importer and depósito even where it holds the filing itself.

Working on a LATAM post-trial access program? bioaccess® is a US-headquartered, LATAM-native operator running regulatory, importadora, and 2–8 °C GDP cold-chain functions directly across the region. If you’re evaluating PTA feasibility in Argentina, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

Sources
- ANMAT Disposición 12792/2016, Boletín Oficial, published 17 November 2016 — https://www.boletinoficial.gob.ar/detalleAviso/primera/154162/20161117
- ANMAT Disposición 7516/2025, Boletín Oficial, published 9 October 2025, in force 1 December 2025 — https://www.boletinoficial.gob.ar/detalleAviso/primera/332695/20251009
- ANMAT Disposición 4616/2019 (RAEM), Boletín Oficial, published 4 June 2019 — https://www.boletinoficial.gob.ar/detalleAviso/primera/208794/20190604
- ANMAT Disposición 828/2017 (Programas de Acceso Expandido), Boletín Oficial, published 26 January 2017 — https://www.boletinoficial.gob.ar/detalleAviso/primera/158296/20170126
- DNPDP Disposición 60-E/2016 (model international data-transfer clauses under Ley 25.326 Art. 12), InfoLEG — https://servicios.infoleg.gob.ar/infolegInternet/anexos/265000-269999/267922/norma.htm
- ANMAT, “Acceso al producto de investigación postensayo clínico” (institutional communication) — https://www.anmat.gob.ar/comunicados/Acceso_al_Producto_Post_Ensayo_Clinico.pdf
- ANMAT, “Preguntas y Respuestas — Disposición 7516/25,” version 1 December 2025 — https://www.argentina.gob.ar/sites/default/files/preguntas_y_respuestas_-disposicion_7516_25_version_1-1-12-25.pdf
- Ministerio de Justicia, normativa record for Disposición 12792/2016 (modifying and complementary norms) — https://www.argentina.gob.ar/normativa/nacional/disposici%C3%B3n-12792-2016-267853/normas-modifican
September 6, 2026
Post-trial access in Panama under Decreto Ejecutivo 21/2026 Article 68
Panama now imposes a binding post-trial access obligation. Article 68 of Decreto Ejecutivo No. 21 de 23 de abril de 2026 requires investigators and sponsors to ensure that every participant who demonstrated clinical or public-health benefit keeps access to the investigational product until that product is commercialized in Panama.

The instrument is four months old. It was published in Gaceta Oficial Digital No. 30510-C on 23 April 2026 and entered into force on promulgation under Article 105. Most post-trial access (PTA) guidance in circulation still describes Panama as having an import mechanism but no obligation, or cites instruments that no longer govern health research. Sponsors closing studies in Panama in 2026 and 2027 are exposed to a requirement their vendors have not read.

What Decreto Ejecutivo 21/2026 actually is

Decreto 21/2026 is the implementing regulation for Titles III and IV of Ley 84 de 14 de mayo de 2019, the statute that regulates and promotes health research in Panama and establishes its governance. Per the Infojurídica record for the decree, Title III of Ley 84/2019 covers the Comité Nacional de Bioética de la Investigación (CNBI) and Title IV covers the management of health research projects. Ley 84/2019 was published in Gaceta Oficial 28775-A on 16 May 2019.

The decree runs 105 articles across fifteen chapters, is signed by President José Raúl Mulino Quintero and Minister of Health Fernando Boyd Galindo, and rests on the Constitution, Ley 66 de 10 de noviembre de 1947 (Código Sanitario) and Ley 84 de 2019. The CNBI hosts its own copy, a practical signal that the bioethics system treats it as the operative reference.

Article 68 verbatim

Article 68 is titled “Acceso a productos por parte de los participantes.” The operative first paragraph reads:

“Los investigadores y patrocinadores deben asegurar a todos los participantes el acceso al producto, siempre que se haya comprobado el beneficio clínico o de salud pública de la intervención durante el estudio; hasta su comercialización en el país, de conformidad con criterios especificados en la reglamentación y en cumplimiento de la normativa correspondiente a la importación de estos productos. Para tales efectos, solicitará ante la autoridad competente, una extensión del permiso de importación del producto utilizado durante la investigación para uso exclusivo de los participantes de dicho estudio hasta cumplir la fase post investigación.”

Our English translation: “Investigators and sponsors must ensure access to the product for all participants, provided the clinical or public-health benefit of the intervention was demonstrated during the study; until its commercialization in the country, in accordance with criteria specified in the regulations and in compliance with the rules governing importation of these products. For such purposes, they shall request from the competent authority an extension of the import permit for the product used during the research, for the exclusive use of the participants in that study, until the post-research phase is complete.”

The second paragraph assigns exceptional cases to the research bioethics committee. The third requires “acuerdos, convenios u otras figuras” reflecting the sponsor’s intent to commercialize the product in Panama, modelled on the CIOMS guidelines, so the sponsor can offer access once study participation ends — expressly “a fin de evitar que la descontinuación de una intervención prive a los participantes de la investigación de capacidades básicas o reduzca considerablemente la calidad de vida que habían logrado durante el estudio.”

Investigators and sponsors are co-obligated

The subject of Article 68 is plural: “los investigadores y patrocinadores.” That is unusual in the region, where most PTA provisions name the sponsor alone. Panama makes the local principal investigator jointly responsible.

The investigator therefore carries a personal regulatory duty to escalate if the sponsor does not fund continued supply, and Article 69 requires the sponsor to secure at least one principal investigator resident in Panama answering scientific, ethical and legal questions — so there is always an identifiable domestic co-obligor the CNBI and the accredited Comité de Bioética de la Investigación (CBI) can hold to account.

Article 68 does not use the word gratuito, so cost allocation is not stated verbatim. It is reached indirectly: Article 71 num. 2 makes the CIOMS international ethical guidelines for health-related research involving humans a fundamental document governing approval, execution and follow-up of research, and Article 66 requires the CBI to apply CIOMS in vulnerability analysis. CIOMS Guideline 6 states that “the obligation to care for participants’ health needs rests with the researcher and the sponsor” and requires plans for “providing continued access to study interventions that have demonstrated significant benefit.” Read with Article 61, under which participants “no deben incurrir en ningún gasto por participar en un estudio de investigación,” the practical outcome is sponsor-funded supply — inferred from Articles 61, 66 and 71, not quoted from Article 68.

Duration: until commercialization in Panama

The end point in Article 68 is “hasta su comercialización en el país” — until the product is commercialized in Panama. There is no fixed month count and no cap. For a device or drug with no Panamanian registration plan that phrasing is open-ended, which is why the third paragraph of Article 68 demands agreements documenting the sponsor’s commercialization intent. A sponsor not planning to commercialize must either negotiate a defined exit with the CBI under the exceptional-cases paragraph or plan for a long tail.

CIOMS supplies the standard the CBI will most likely apply: provision “may end as soon as the study intervention is made available through the local public health-care system or after a predetermined period of time that the sponsors, researchers and community members have agreed before the start of a trial.” A sponsor that has not defined the PTA exit at protocol stage has weaker footing at study close.

The extension of the import permit

Article 68 names a specific filing: an extensión del permiso de importación covering the investigational product for the exclusive use of that study’s participants, through the post-research phase. It is not a compassionate-use application — it is an extension of the existing research import permit, scoped to a closed cohort.

The surrounding machinery sits in Chapter XIII. Under Article 95, where a high-risk study uses medicines or products for human health, product evaluation before the trial starts belongs to the Dirección Nacional de Farmacia y Drogas (DNFD), filed through the RESEGIS platform of the Dirección General de Salud Pública with GMP certification, certificate of analysis, investigator’s brochure and product manuals; the DNFD answers within fifteen working days. Article 99 states plainly that “la importación de los productos de investigación se hará en base al registro del proyecto de investigación en la plataforma RESEGIS, la aprobación ética y su autorización por la Dirección Nacional de Farmacia y Drogas.” Article 100 makes the investigator or tramitante responsible for evidencing all approval and importation documentation in RESEGIS.

Three approvals therefore gate every post-trial shipment: an active RESEGIS project record, CBI ethical approval covering the post-trial phase, and DNFD authorization. Article 97 adds labelling minimums — identification or code, lot, expiry, storage conditions, special warnings — with Spanish required except where the DNFD accepts English on prior justification. For a 2–8 °C product that chain must hold through a supply period that may run years past the last patient visit.

RESEGIS, the DNFD and the CBI

RESEGIS is the Registro y Seguimiento de la Investigación para la Salud, established under Article 79 in the Dirección General de Salud Pública. The MINSA introductory guide confirms that the principal investigator registers the project and that a third party or tramitante may file on the investigator’s behalf provided the investigator is already enrolled. That tramitante route is how a sponsor without a Panamanian legal entity gets filings made locally.

The CBI’s role in PTA is decision-making, not advisory. Article 68 paragraph 2 gives the accredited committee authority over exceptional cases and requires it to determine the applicable mechanisms against previously defined criteria; Article 66 requires the CNBI and accredited CBIs to hold a standard operating procedure for these situations. The CBI that approved the protocol is the body that will approve, condition or reject a proposed PTA arrangement, and Article 91 requires the investigator to load approval certifications into RESEGIS.

What Article 104 repealed — and what it did not

Article 104 repeals Decreto Ejecutivo No. 1843 de 16 de diciembre de 2014, Decreto Ejecutivo No. 6 de 3 de febrero de 2015 (the prior bioethics regulation) and Resolución No. 390 de 6 de noviembre de 2003. Any PTA position built on the pre-2026 bioethics-committee framework rests on repealed instruments.

Article 104 does not repeal Decreto Ejecutivo No. 27 de 10 de mayo de 2024, published in Gaceta 30028-C. That decree implements Ley 419 de 1 de febrero de 2024, the commercial medicines and public-procurement statute, and defines “acceso a medicamento post-estudio clínico” in Article 2 num. 3 as a pharmaceutical product used in a clinical study in Panama, supplied on the treating investigator’s justification of continued benefit “hasta que este esté comercialmente disponible en el país o según lo determine el Comité de Bioética en Investigación.” It stays part of the medicines regime. What changed on 23 April 2026 is that the obligation now lives in Article 68 of the health-research decree. Decreto 27/2024 describes an available route; Article 68 imposes a must.

Misconceptions worth correcting

“Panama has a mechanism but no mandate.” Accurate before 23 April 2026, wrong now. Article 68 uses deben asegurar.

“Ley 419/2023 is the Panamanian PTA law.” The number is right, the year is wrong, and the statute is the wrong one. It is Ley 419 of 1 February 2024, and it regulates commercial medicines and public procurement, not health research. The health-research statute is Ley 84 de 14 de mayo de 2019.

“Decreto Ejecutivo 27/2024 is the operative PTA instrument.” It is the operative instrument for the medicines regime and it still contains the definition, but the binding continued-supply obligation for study participants now sits in Decreto 21/2026 Article 68.

“PTA in Panama is a compassionate-use filing.” Article 68 instead routes it through an extension of the research import permit for a defined cohort, evidenced in RESEGIS under Articles 99 and 100.

What sponsors should do before database lock

Define the PTA exit in the protocol and informed consent, not at close-out. Get the CBI to approve the arrangement and the acuerdos o convenios required by Article 68 paragraph 3 while the study is still open. Keep the RESEGIS record live through the post-research phase. Budget the import-permit extension, DNFD interaction and Spanish labelling as a workstream distinct from the trial, with a named local filer able to act as tramitante. And confirm which accredited CBI holds the file — that committee, not MINSA centrally, decides the exceptional-case mechanism.

Working on a LATAM post-trial access program? bioaccess® is a US-headquartered, LATAM-native operator running regulatory, importadora, and 2–8 °C GDP cold-chain functions directly across the region. If you’re evaluating PTA feasibility in Panama or elsewhere in Latin America, contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.

Frequently asked questions

What does Panama require for post-trial access?
Panama requires investigators and sponsors to ensure that every trial participant who demonstrated clinical or public-health benefit continues to receive the investigational product until it is commercialized in Panama. The requirement is Article 68 of Decreto Ejecutivo No. 21 de 23 de abril de 2026. Operationally the sponsor must request an extension of the research import permit covering only that study’s participants, keep the project record active in the RESEGIS platform, obtain Dirección Nacional de Farmacia y Drogas authorization for importation under Article 99, and document the arrangement with the accredited research bioethics committee that approved the protocol.

Is post-trial access mandatory in Panama?
Yes, since 23 April 2026. Article 68 of Decreto Ejecutivo 21/2026 uses the mandatory verb deben asegurar (“must ensure”) and names both investigators and sponsors as obligors. The decree entered into force on promulgation under Article 105 and was published in Gaceta Oficial Digital No. 30510-C. Before that date, Panama had a definitional and import route for post-study medicine access under Decreto Ejecutivo 27/2024 but no clearly worded affirmative duty on the sponsor. Guidance describing Panama as a mechanism-only jurisdiction is out of date.

Who pays for post-trial access in Panama?
In practice the sponsor. Article 68 does not use the word gratuito, so cost allocation is not stated verbatim in that article. It arrives through three linked provisions: Article 61 states that participants must not incur any expense for participating in a research study; Article 71 num. 2 makes the CIOMS international ethical guidelines a fundamental governing document; and CIOMS Guideline 6 places the obligation to meet participants’ health needs on the researcher and the sponsor. Sponsors should budget product, importation, labelling, cold-chain and local filing costs.

How long must sponsors provide post-trial access in Panama?
Until the product is commercialized in Panama — “hasta su comercialización en el país” in Article 68. There is no fixed duration and no statutory cap. Where the sponsor does not intend to register and commercialize in Panama, the obligation is open-ended on its face, and the exit must be negotiated with the research bioethics committee under the exceptional-cases paragraph of Article 68. CIOMS Guideline 6 supports ending provision once the intervention is available through the local public health system or after a period agreed before the trial started, which is why the exit should be defined in the protocol.

What is Decreto Ejecutivo 21/2026?
Decreto Ejecutivo No. 21 de 23 de abril de 2026 is the Panamanian regulation implementing Titles III and IV of Ley 84 de 14 de mayo de 2019 on health research. It has 105 articles across fifteen chapters covering the CNBI, accredited bioethics committees, participant rights, the RESEGIS registration platform, the administrative review procedure, and Chapter XIII on research using medicines and other products for human health. It was published in Gaceta Oficial Digital No. 30510-C and entered into force on promulgation.

What happened to Decreto Ejecutivo 27/2024?
It is still in force as the implementing regulation for Ley 419 de 1 de febrero de 2024, the commercial medicines and public-procurement statute, and it still defines acceso a medicamento post-estudio clínico in Article 2 num. 3. Article 104 of Decreto 21/2026 repeals Decreto Ejecutivo 1843/2014, Decreto Ejecutivo 6/2015 and Resolución 390/2003 — not Decreto 27/2024. What changed is authority: the binding post-trial obligation on investigators and sponsors now comes from Article 68 of Decreto 21/2026, so citing Decreto 27/2024 as the whole picture understates the duty.

Does Panama post-trial access apply to medical devices?
Article 68 refers to “el producto” without limiting it to medicines, and Chapter XIII is titled “De la investigación para la salud donde se utilizan medicamentos y otros productos para la salud humana.” Article 95 covers “medicamentos o productos para la salud humana,” and the glossary in Article 2 num. 8 defines high-risk intervention technology as a medical or health technology used to intervene in diagnosis, treatment, prevention or rehabilitation. On that reading device studies are within scope. Sponsors of device trials should confirm the specific import pathway with the Dirección Nacional de Farmacia y Drogas rather than assume the medicine route applies unchanged.

What is the difference between Ley 84/2019 and Ley 419/2024?
Ley 84 de 14 de mayo de 2019 regulates and promotes health research and establishes its governance; its Title III creates the Comité Nacional de Bioética de la Investigación and its Title IV governs management of health research projects. Ley 419 de 1 de febrero de 2024 regulates medicines and other products for human health and their public procurement. Post-trial access as an obligation flows from Ley 84/2019 through Decreto 21/2026 Article 68. Note also that the frequently seen citation “Ley 419/2023” is wrong on the year.

Who reviews and approves post-trial access requests in Panama?
Three bodies, in sequence. The accredited Comité de Bioética de la Investigación that approved the protocol reviews the post-trial arrangement and, under Article 68 paragraph 2, decides exceptional cases against previously defined criteria. The Dirección Nacional de Farmacia y Drogas evaluates the product and authorizes importation under Articles 95 and 99. The Dirección General de Salud Pública operates the RESEGIS platform under Article 79, where the investigator or tramitante must evidence all approval and importation documentation under Article 100.

Sources
September 6, 2026
Understanding Regulatory Requirements for Class 2b Medical Devices
Introduction

Navigating the complex landscape of medical device regulation is crucial for ensuring the safety and efficacy of products within the European Union. The EU Medical Device Regulation (MDR) categorizes devices based on their risk, with Class 2b devices requiring stringent regulatory scrutiny due to their moderate to high-risk profile. This article delves into the intricacies of the EU MDR classification system, focusing on the key regulatory requirements, conformity assessment procedures, and the importance of post-market surveillance for Class 2b medical devices.

It also highlights the critical role of a robust Quality Management System (QMS) in maintaining compliance and explores best practices for achieving regulatory success. As the regulatory environment continues to evolve, staying informed and proactive is essential for manufacturers to ensure their devices meet the highest standards of safety and performance.

EU MDR Classification System Overview

‘The EU Regulation for Healthcare Instruments (MDR) establishes a classification system for based on their risk to patients and users.’. , identified as moderate to high-risk, undergo a more rigorous assessment process compared to lower-class items. This classification is crucial to guaranteeing the protection and effectiveness of prior to their sale in the European Union. Key criteria for classification include intended use, duration of contact, and invasiveness, which dictate the .

Recent data indicates a significant number of (IVDs), particularly high-risk Class D instruments, have not yet transitioned to the new rules. This includes critical tests for infections in blood transfusions and organ donations. To address this, the to give manufacturers and notified bodies more time to complete the necessary conformity assessments. This extension aims to safeguard the high standards of safety and public health set by the MDR. Furthermore, actions to expedite the deployment of EUDAMED, a comprehensive database of all and IVDs in the EU market, are suggested to improve transparency and assist in the execution of the regulatory framework.

Key Regulatory Requirements for Class 2b Medical Devices

Producers of Class 2b medical equipment must comply with strict regulatory standards as detailed in the . Foremost among these is the implementation of a comprehensive , essential for maintaining high standards in security and performance. A meticulous risk assessment process is imperative, identifying potential hazards and mitigating risks effectively. Clinical information plays an essential part, as it must clearly show the product’s reliability and effectiveness, aligning with the strict standards outlined in the EU MDR.

Additionally, manufacturers are required to compile extensive . This documentation must provide robust evidence of compliance with applicable regulations, including detailed evaluation reports (CERs). The CER is especially important, acting as a thorough evaluation of the safety and performance based on gathered from multiple sources. This is an essential element for acquiring the CE marking, which is required for promoting health products within the European Union.

Staying updated with is paramount. The EUDAMED database improves clarity, offering a thorough summary of all healthcare products accessible in the European market. This initiative intends to enhance the traceability and supervision of medical instruments, ensuring that they meet the highest standards of security and effectiveness. ‘Recent proposals by the European Commission seek to expedite the mandatory launch of EUDAMED components and evaluate the impact of current legislation on availability, particularly for specialized equipment like those for pediatric or orphan diseases.’.

In this evolving regulatory landscape, is essential. It entails ongoing observation of equipment in practical environments, utilizing techniques such as unplanned reporting, registries, and electronic health records to collect information on long-term reliability and efficacy. This ongoing vigilance helps identify and mitigate potential risks, thereby .

Ensuring compliance requires a proactive approach. As regulations and guidelines are subject to change, manufacturers must be prepared to adapt their processes and documentation accordingly. This dynamic environment necessitates vigilance and flexibility, underscoring the importance of staying informed and compliant to maintain market access and uphold patient well-being.

Clinical Evidence and Performance Standards

For Class 2b instruments, medical proof is essential to show safety and effectiveness. This evidence generally includes medical investigations, literature reviews, and . Producers must create a clear assessment plan aligned with the device’s intended use and . Following set and benchmarks improves the credibility of the . Moreover, interacting with regulatory agencies early in the development process can offer insights into the essential data requirements.

Essential elements of consist of information from research carried out for the product being assessed and from research for previously sold comparable products. A state-of-the-art report, which includes a literature review of medical texts, guidelines, and peer-reviewed literature, is essential to demonstrate what is currently accepted as good practice. This aids in demonstrating that an apparatus is comparable to similar products available and poses minimal risk.

A thorough is essential, including negative occurrences, equipment failures, and possible concerns from the medical assessment. A summary of , including a meta-summary of overall supporting the reliability and performance of the instrument, is necessary to conclude its ability to meet the intended clinical purpose. Once these reports are assembled, manufacturers must submit a to indicate the product complies with MDR stipulations. This declaration must be kept up to date and available upon request to any competent authority.

Post-market reports mandated by the FDA provide information on a product and enable manufacturers to address concerns raised through passive and active monitoring systems. These encompass 522 Studies, which assess specific features of or overall performance of the product once it is accessible in the marketplace, and Post-Approval Studies (PAS), which collect further information on the product’s long-term reliability, performance, and effectiveness, providing interim results to the FDA as research is conducted. Recalls must also be reported, detailing any action by manufacturers to recall, withdraw, or correct a product.

Conformity Assessment Procedures for Class 2b Devices

The procedure for Class 2b medical instruments involves a comprehensive evaluation to ensure adherence to protection and performance criteria. ‘Producers must involve a Notified Body to carry out this assessment, which encompasses audits of the , review of technical documentation, and evaluation of .’. The is especially vital, as it entails a thorough appraisal of the equipment’s safety and performance based on gathered clinical data. The Report (CER), a key component of the technical documentation, plays a pivotal role in this process by demonstrating compliance with EU regulations.

The result of the Notified Body’s evaluation decides if the product can carry the , indicating compliance with EU regulations. Maintaining open communication with the Notified Body throughout the process is essential to address any concerns or additional requirements.

The European Commission’s recent proposal to extend the application period for the In Vitro Diagnostic Medical Devices Regulation (IVDR) underlines the importance of ensuring patient care while improving the availability of essential healthcare products. This action seeks to improve clarity and accelerate the introduction of components in the European Database on Medical Devices (EUDAMED), thus offering a complete summary of all items accessible in the European market.

In summary, the conformity evaluation for Class 2b healthcare instruments is an essential procedure that guarantees the security and effectiveness of these instruments through thorough assessment and compliance with regulatory criteria.

Post-Market Surveillance and Reporting Obligations

(PMS) is a critical component of the lifecycle management of . This stage is essential for recognizing and tackling possible concerns and enhancing equipment performance over time. Manufacturers are required to monitor the performance of their products after they are on the market, collecting data on any , incidents, or trends that may arise. Various methods are employed to collect this crucial data, including passive surveillance systems like spontaneous reporting by healthcare professionals and patients, active surveillance through registries or studies, and the utilization of electronic health records and administrative databases. These methods allow for the ongoing observation of equipment in practical environments, offering important information about their long-term reliability and efficacy.

The significance of PMS cannot be overstated. It serves a crucial function in , assisting in identifying and reducing possible hazards related to . For instance, more than 1.7 million injuries and 83,000 deaths over a recent 10-year period in the U.S. have been potentially connected to . Swift action based on PMS findings can prevent harm and contribute to the long-term well-being of patients. The FDA has started developing a monitoring system to search for possible concerns regarding these products, beginning with a small number and growing gradually, despite difficulties in financing and patient recognition.

Reporting duties to , including incident documentation and periodic update reports (PSURs), must be followed, ensuring transparency and adherence. New regulatory structures are being created to improve and guarantee prompt access to essential equipment. For instance, the UK’s new regulations aim to provide greater international harmonization and patient-centered requirements, reflecting the rapid advancements in healthcare technology. Dr. Laura Squire, Med Tech Regulatory Reform Lead, emphasized that these regulations will strengthen the MHRA’s ability to keep patients safe while fostering an environment that encourages the launch of innovative healthcare products.

Despite its importance, effective PMS faces challenges such as underreporting of , limited resources for monitoring, and the absence of standardized reporting processes. Tackling these issues is essential to guaranteeing the ongoing security and efficacy of healthcare tools in practical environments. Manufacturers must remain vigilant and proactive in their PMS efforts to safeguard patient health and comply with regulatory standards.

Quality Management System (QMS) Requirements

A strong is essential for the compliance of Class 2b healthcare products. Manufacturers must establish and maintain a QMS that adheres to , which provide a for quality management. This standard is specifically designed to help manufacturers develop strong systems from the ground up, ensuring that they meet regulations, assess and improve supply bases, and maintain “best-in-class” management standards. Key components of the QMS include processes for , document management, supplier evaluation, and .

The ISO 13485 standard specifies that management must ensure customer requirements are met and maintain the integrity of the QMS when changes are implemented. Regular audits and reviews of the QMS ensure its effectiveness and compliance with . Additionally, the competence, awareness, and training of personnel are crucial, particularly in roles that impact product quality. By following this quality system, manufacturers gain a competitive edge in quality, reliability, delivery, and service, fostering enhanced trust with customers.

Furthermore, the QMS must include dynamic forms for quality event management, as highlighted by the innovative Advanced QEM platform, which allows for more efficient and adaptable quality event management processes. This advanced approach has been recognized as one of the most innovative products in the industry, significantly improving the approach to quality event management.

By adhering to these standards and continuously enhancing , manufacturers can proactively identify and mitigate potential risks. This results in the creation of high-quality instruments that meet regulatory standards and offer optimal patient results, aiding in the overall progress of the healthcare equipment sector.

Best Practices for Compliance and Regulatory Success

To attain adherence and , producers of Class 2b healthcare instruments should embrace a proactive strategy. This involves staying informed about changes in regulations and engaging with stakeholders early in the development process. Utilizing a is essential. Establishing strong relationships with Notified Bodies and can facilitate smoother interactions and enhance understanding of compliance requirements.

Putting resources into training for personnel engaged in regulatory matters guarantees that the group is adequately prepared to handle the intricacies of . ‘The importance of cannot be emphasized enough, as it plays a crucial role in patient well-being by identifying and reducing potential hazards linked to healthcare tools.’. Different approaches, such as passive and active monitoring systems, are used to gather important information concerning the reliability and performance of medical devices.

Furthermore, distinguishing and accurately representing health benefits and claims is critical. The EU MDR and MDCG emphasize that claims about a product’s intended purpose, safety, and performance must be supported by factual evidence and data. This necessitates close collaboration between regulatory teams and marketing departments to align the product’s market expectations with its actual clinical benefits.

A certificate of competence in can further enhance a professional’s ability to establish and maintain a compliant risk management system for healthcare products. This is a very adaptable skill throughout the healthcare equipment sector and is in great demand. Understanding how software is regulated as a medical device is also essential, as the Same market is poised for significant growth. Navigating this complex terrain requires a firm grasp of regional nuances, documentation requirements, and compliance processes.

Conclusion

Navigating the complexities of the EU Medical Device Regulation (MDR) is essential for ensuring the safety and efficacy of Class 2b medical devices. The classification system, which categorizes devices based on their risk profile, underscores the importance of adhering to stringent regulatory requirements. Manufacturers must implement a robust Quality Management System (QMS) and engage in thorough conformity assessment procedures to demonstrate compliance with safety standards.

The significance of clinical evidence and a comprehensive risk assessment cannot be overstated, as they are pivotal in establishing a device’s safety and performance.

Post-market surveillance (PMS) plays a critical role in the lifecycle management of Class 2b devices. Continuous monitoring allows manufacturers to identify and address potential safety issues, thereby safeguarding patient health. The obligation to maintain transparent reporting practices further reinforces the commitment to quality and compliance.

As the regulatory landscape evolves, manufacturers must remain vigilant, adapting to changes and ensuring that their devices not only meet current standards but also anticipate future requirements.

In summary, achieving regulatory success in the medical device sector requires a proactive approach, characterized by strong stakeholder engagement, ongoing education, and a commitment to quality. By fostering a culture of compliance and innovation, manufacturers can enhance patient safety while navigating the challenges posed by the evolving regulatory environment. The importance of aligning clinical claims with factual evidence and maintaining effective communication with regulatory bodies will be critical for sustained market access and the overall advancement of the medical device industry.

Ready to navigate the complexities of medical device regulations with confidence? Contact bioaccess™ today to learn how our expert CRO services can support your compliance and innovation efforts.

Frequently Asked Questions

What is the EU Regulation for Healthcare Instruments (MDR)?

The MDR establishes a classification system for healthcare products based on their risk to patients and users, ensuring the safety and effectiveness of medical instruments before they are sold in the European Union.

How are Class 2b items classified under MDR?

Class 2b items are identified as moderate to high-risk products that undergo a more rigorous assessment process compared to lower-class items, based on criteria such as intended use, duration of contact, and invasiveness.

What is the significance of the recent proposals from the European Commission regarding high-risk instruments?

The proposals aim to extend transition periods for high-risk Class D in vitro diagnostic instruments, allowing manufacturers and notified bodies more time to complete conformity assessments. This is to ensure safety and public health standards are maintained.

What is required from manufacturers of Class 2b medical equipment?

Manufacturers must implement a comprehensive Quality Management System (QMS), conduct a meticulous risk assessment, compile extensive technical documentation, and provide clinical evidence demonstrating the product’s reliability and effectiveness.

What is the Clinical Evaluation Report (CER)?

The CER is a key component of the technical documentation that evaluates the safety and performance of the medical device based on clinical data. It is essential for obtaining the CE marking, which is required for marketing within the EU.

How does post-market surveillance (PMS) function for Class 2b medical products?

PMS involves ongoing monitoring of products in practical environments to collect data on any adverse events or performance issues. This process helps identify potential risks and contributes to patient safety.

What is the importance of the EUDAMED database?

EUDAMED is a comprehensive database of all healthcare products and in vitro diagnostics in the EU market. It improves transparency, traceability, and assists in the execution of the regulatory framework.

What challenges do manufacturers face in maintaining compliance?

Manufacturers must stay updated with changing regulations, adapt their processes and documentation, and ensure effective post-market surveillance while addressing issues like underreporting of adverse events.

What is the role of a Notified Body in the conformity assessment procedure?

A Notified Body is involved in evaluating compliance with EU regulations, conducting audits of the QMS, reviewing technical documentation, and assessing clinical data to determine if the product can carry the CE mark.

What is the significance of a strong Quality Management System (QMS)?

A robust QMS ensures compliance with ISO 13485 standards, helping manufacturers maintain high quality and reliability in their products, thus fostering trust with customers and enhancing overall patient safety.

How can manufacturers proactively ensure adherence to regulations?

Manufacturers should engage with stakeholders early in the development process, maintain strong relationships with regulatory authorities, invest in staff training, and ensure that all claims made about their products are supported by factual evidence and data.

What methods are employed for post-market surveillance?

Methods include passive surveillance (such as spontaneous reporting), active surveillance (through registries or studies), and utilizing electronic health records to gather essential data on product performance and safety.

Why is it critical to have accurate risk-benefit evaluations for Class 2b instruments?

Conducting thorough risk-benefit evaluations helps ensure that potential hazards are identified and mitigated, thus protecting patient health and ensuring the effectiveness of the medical instruments in use.

List of Sources
1. EU MDR Classification System Overview
  - ec.europa.eu (https://ec.europa.eu/commission/presscorner/detail/en/QANDA_24_347)
  - alirahealth.com (https://alirahealth.com/our-services/medical-device-regulation-mdr)
  - med-technews.com (https://med-technews.com/news/Medtech-Regulatory-News/european-commission-proposes-extended-ivdr-transition)
  - medicaldevice-network.com (https://medicaldevice-network.com/news/how-is-europes-medtech-industry-navigating-the-eu-mdr)
  - easymedicaldevice.com (https://easymedicaldevice.com/how-to-register-medical-device-saudi-arabia?utm_source=rss&utm_medium=rss&utm_campaign=how-to-register-medical-device-saudi-arabia)
  - ec.europa.eu (https://ec.europa.eu/commission/presscorner/detail/en/QANDA_24_347)
  - fda.gov (https://fda.gov/medical-devices/neurological-devices/regulatory-overview-neurological-devices)
2. Key Regulatory Requirements for Class 2b Medical Devices
  - schlafenderhase.com (https://schlafenderhase.com/ebooks/medical-device-report-how-are-compliance-strategies-evolving)
  - ec.europa.eu (https://ec.europa.eu/commission/presscorner/detail/en/QANDA_24_347)
  - medtechintelligence.com (https://medtechintelligence.com/feature_article/role-of-clinical-evaluation-report-consultants)
  - starfishmedical.com (https://starfishmedical.com/blog/how-post-market-surveillance-enhances-medical-device-safety)
  - medicaldevice-network.com (https://medicaldevice-network.com/news/high-risk-devices-can-be-exempted-from-mandatory-trials-under-eu-mdr)
  - starfishmedical.com (https://starfishmedical.com/blog/esg-medical-device-impact)
  - greenlight.guru (https://greenlight.guru/blog/navigating-clinical-evaluations-and-investigations-in-medtech)
  - med-technews.com (https://med-technews.com/news/Medtech-Regulatory-News/european-commission-proposes-extended-ivdr-transition)
  - medicalplasticsnews.com (https://medicalplasticsnews.com/news/medical-plastics-regulatory-policy-news/european-commission-proposes-extended-timeline-for-ivd-compl)
  - greenlight.guru (https://greenlight.guru/blog/post-market-surveillance-medical-devices-ivds)
  - medtechintelligence.com (https://medtechintelligence.com/feature_article/role-of-clinical-evaluation-report-consultants)
  - alirahealth.com (https://alirahealth.com/our-services/medical-device-regulation-mdr)
3. Clinical Evidence and Performance Standards
  - raps.org (https://raps.org/products/medical-device-standards-specifications-and-testing?utm_campaign=online_u_device_standards&utm_source=twitter&utm_medium=social)
  - elsevier.com (https://elsevier.com/industry/medical-device-regulation?dgcid=RN_CM_Sourced_400006591#2-mdr-webinars)
  - schlafenderhase.com (https://schlafenderhase.com/ebooks/medical-device-report-how-are-compliance-strategies-evolving)
  - gov.uk (https://gov.uk/government/publications/equity-in-medical-devices-independent-review-final-report)
  - gao.gov (https://gao.gov/products/gao-24-106699?utm_medium=social&utm_source=twitter&utm_campaign=usgao)
  - fda.gov (https://fda.gov/news-events/press-announcements/fda-roundup-january-19-2024)
  - fda.gov (https://fda.gov/news-events/press-announcements/fda-roundup-november-21-2023)
  - greenlight.guru (https://greenlight.guru/blog/navigating-clinical-evaluations-and-investigations-in-medtech)
  - fda.gov (https://fda.gov/about-fda/cdrh-innovation/medical-device-coverage-initiatives-connecting-payors-payor-communication-task-force)
4. Conformity Assessment Procedures for Class 2b Devices
  - wcedmisten.fyi (https://wcedmisten.fyi/post/medical-device-analysis)
  - fda.gov (https://fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/division-standards-and-conformity-assessment)
  - schlafenderhase.com (https://schlafenderhase.com/ebooks/medical-device-report-how-are-compliance-strategies-evolving)
  - celegence.com (https://celegence.com/eu-mdr-ivdr-conformity-assessment)
  - greenlight.guru (https://greenlight.guru/blog/recent-fda-draft-guidances)
  - medtechintelligence.com (https://medtechintelligence.com/feature_article/role-of-clinical-evaluation-report-consultants)
  - starfishmedical.com (https://starfishmedical.com/blog/risk-management-fda-guidance-iso-10993-1)
  - med-technews.com (https://med-technews.com/news/Medtech-Regulatory-News/european-commission-proposes-extended-ivdr-transition)
  - medtechintelligence.com (https://medtechintelligence.com/feature_article/role-of-clinical-evaluation-report-consultants)
  - fda.gov (https://fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/division-standards-and-conformity-assessment)
  - ec.europa.eu (https://ec.europa.eu/commission/presscorner/detail/en/QANDA_24_347)
  - gov.uk (https://gov.uk/government/publications/implementation-of-the-future-regulation-of-medical-devices/statement-of-policy-intent-international-recognition-of-medical-devices)
5. Post-Market Surveillance and Reporting Obligations
  - starfishmedical.com (https://starfishmedical.com/blog/how-post-market-surveillance-enhances-medical-device-safety)
  - fda.gov (https://fda.gov/medical-devices/coronavirus-covid-19-and-medical-devices/adverse-event-reporting-medical-devices-under-emergency-use-authorization-eua)
  - schlafenderhase.com (https://schlafenderhase.com/ebooks/medical-device-report-how-are-compliance-strategies-evolving)
  - gao.gov (https://gao.gov/products/gao-24-106699?utm_medium=social&utm_source=twitter&utm_campaign=usgao)
  - medtechintelligence.com (https://medtechintelligence.com/news_article/mhra-releases-roadmap-of-future-uk-medical-device-regulation)
  - greenlight.guru (https://greenlight.guru/blog/class-iii-medical-device)
  - starfishmedical.com (https://starfishmedical.com/blog/how-post-market-surveillance-enhances-medical-device-safety)
6. Quality Management System (QMS) Requirements
  - celegence.com (https://celegence.com/harmonizing-iso-149712019-fda-qmsr-medical-device-safety)
  - fda.gov (https://fda.gov/medical-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp/quality-management-system-regulation-final-rule-amending-quality-system-regulation-frequently-asked)
  - cmtc.com (https://cmtc.com/blog/iso-13485-for-medical-device-and-equipment-manufacturing)
  - qualitydigest.com (https://qualitydigest.com/inside/fda-compliance-news/mastercontrol-launches-advanced-quality-event-management-software-020824?utm_source=dlvr.it&utm_medium=twitter)
  - schlafenderhase.com (https://schlafenderhase.com/ebooks/medical-device-report-how-are-compliance-strategies-evolving)
  - fda.gov (https://fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/division-standards-and-conformity-assessment)
  - fda.gov (https://fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp)
  - fda.gov (https://fda.gov/medical-devices/postmarket-requirements-devices/quality-system-qs-regulationmedical-device-current-good-manufacturing-practices-cgmp)
  - greenlight.guru (https://greenlight.guru/blog/plm-qms-solutions-medtech)
7. Best Practices for Compliance and Regulatory Success
  - starfishmedical.com (https://starfishmedical.com/blog/5-regulatory-considerations-for-developing-a-combination-device)
  - greenlight.guru (https://greenlight.guru/blog/navigating-clinical-evaluations-and-investigations-in-medtech)
  - starfishmedical.com (https://starfishmedical.com/blog/how-post-market-surveillance-enhances-medical-device-safety)
  - medtechintelligence.com (https://medtechintelligence.com/column/navigating-global-regulations-for-samd)
  - schlafenderhase.com (https://schlafenderhase.com/ebooks/medical-device-report-how-are-compliance-strategies-evolving)
  - achievexl.com (https://achievexl.com/iso-14971-certification-training)
  - medicaldevice-network.com (https://medicaldevice-network.com/features/regulatory-changes-in-the-us-and-uk-to-watch-in-2024)
  - med-technews.com (https://med-technews.com/medtech-insights/medtech-regulatory-insights/simplifying-samd-regulatory-compliance-with-ai-driven-expert)
  - agencyiq.com (https://agencyiq.com/blog/the-fda-is-in-dire-need-of-some-regulatory-design-thinking?cid=aiq_23q4_fda_blog-articles)
  - jamanetwork.com (https://jamanetwork.com/journals/jama-health-forum/fullarticle/2813650?utm_source=jps&utm_medium=email&utm_campaign=author_alert-jamanetwork&utm_content=author-author_engagement&utm_term=1m)
September 3, 2026
Adverse event and SUSAR reporting to ANVISA during a FIH trial in Brazil
Device FIH safety reporting in Brazil is not drug pharmacovigilance with the logo swapped. The clocks are different, the form is different, and “SUSAR” is a useful overlapping idea — not the name of the ANVISA device channel.

If your FIH data are meant to support a later FDA investigational or marketing file, you still report to ANVISA under device rules. You then keep a narrative and causality trail that an IDE medical officer can read without asking why Brazil used a drug module.

The statute you actually report under

Current device clinical-investigation procedure is RDC 837/2023, announced by ANVISA in its December 2023 update. It replaced RDC 548/2021, which had already revoked RDC 10/2015. Chapter VII is the safety-monitoring chapter. Do not write SOPs against RDC 10/2015 clocks, and do not paste RDC 945/2024 drug-trial SUSAR text into a device FIH plan.

Law 14.874/2024 still applies to the ethics layer. Article 26 requires the sponsor to notify investigators, the institution, ethics bodies, and the sanitary authority of findings that may adversely affect participant safety. Article 55 makes serious adverse events reportable to the CEP that approved the research, and, for clinical trials intended to support sanitary registration, also to the sanitary authority. The law does not replace RDC 837/2023’s device form or day counts.

NotivisaEC is the device channel; VigiMed is not

ANVISA’s manual for adverse-event notification and safety monitoring in clinical trials involving investigational medical devices is the operational text. It tells sponsors to notify unexpected serious adverse events to ANVISA on the electronic NotivisaEC form:

https://pesquisa.anvisa.gov.br/index.php/847543?lang=pt-BR

The manual is explicit that those notifications go exclusively through that form, and that login is not required to notify. It also states that a SUSAR (suspected unexpected serious adverse reaction) sits inside the criteria for a notifiable serious event — but the RDC criteria are not limited to the drug-style SUSAR definition. If your safety database only flags “SUSAR = yes,” you will miss device cases that are unexpected, serious, and causally possible even when a medical monitor refuses the drug label.

VigiMed-Pesquisa Clínica is ANVISA’s channel for SUSARs in drug and biologic trials, under the drug clinical-trial framework (currently discussed by the Agency against RDC 945/2024). ANVISA’s own clinical-trial notification page describes VigiMed in that medicine context and requires a study-specific VigiMed registration, including the DEEC expediente. That is not the device DICD file. Do not open a VigiMed-Pesquisa Clínica account as a substitute for NotivisaEC on an implant FIH.

Post-market technovigilance (commercial devices after registro or notification) is a different duty and a different system generation. Keep investigational NotivisaEC cases out of the commercial technovigilance queue until the unit is actually on the market.

What is notifiable, in device language

RDC 837/2023 defines an adverse event as any unfavorable medical occurrence in a participant that is not necessarily causal. A serious adverse event includes death; a life-threatening event; persistent or significant disability; hospitalization or prolongation of hospitalization; congenital anomaly; suspected transmission of an infectious agent via a medical device; or a clinically significant event.

An event is unexpected when it is not described as an adverse reaction in the investigator brochure or in the instructions for use / operator manual of the investigational device. That is why the brochure is a reporting instrument, not a marketing appendix.

The sponsor must notify ANVISA of unexpected serious events that occurred in Brazil and whose causality versus the investigational product is possible, probable, or definite. Expected serious events, unrelated events, and non-serious events still belong in the sponsor’s file and in the annual tabulated report. They are not the 7- and 15-day electronic cases.

Causality is not a hallway opinion. The device manual points sponsors to the WHO-UMC causality scale (possible / probable / certain, plus the lower categories) when classifying every event, including non-serious ones. Train Brazilian investigators on that scale before site initiation. A PI who only knows “related / not related” will force you to re-code under the clock.

The clocks — investigator, sponsor, ANVISA

RDC 837/2023 is blunt on time. Count from knowledge, not from “when safety closed the query.”
- Investigator → sponsor: serious adverse events or death within 24 hours of the investigator becoming aware.
- Sponsor → ANVISA, fatal or life-threatening, unexpected, causality possible/probable/definite, Brazil: document and notify on the electronic form within 7 calendar days of sponsor awareness. Complementary follow-up goes on the same form within 8 calendar days after that initial notification.
- Sponsor → ANVISA, all other unexpected serious events meeting the same causality and territory tests: 15 calendar days from sponsor awareness.
Immediate protective measures are not optional. On a notifiable serious event, the form expects the measures already taken, the plan if the same event recurs, the care location, and identifiers that can trace the event and the participant. Notification is due even if you are in the middle of a brochure update, a protocol amendment, an annual report, or an early termination.

Temporary safety suspensions of the investigation must be notified to ANVISA within 7 calendar days of the suspension, with reasons, scope, treatment interruption, risk-minimization measures, and recruitment status. Restart waits for ANVISA approval published in the Official Gazette. That is a calendar item, not a medical-monitor footnote.

DSUR / ICH E2F is not a substitute for the device annual report

ANVISA publishes the ICH E2F Development Safety Update Report in its medicines clinical-trial library. E2F is a drug-development periodic-safety standard. It is a sensible internal template if the same legal entity also runs an IND. It is not the device annual report that RDC 837/2023 requires.

For a DICD, the sponsor files an annual follow-up report as a secondary petition to the DICD, covering Brazilian centers only, in tabulated form: title, reference number, recruitment status, amendment history, enrollment by site, deviations and violations by site, and a description of all adverse events in the period, with the case-report-form participant codes. The anniversary is the date of the Brazil start-of-investigation notification. The petition is due within 60 calendar days of that anniversary. Missing the report can cancel the investigation.

The final report is a different secondary petition, due within 12 months of the investigation’s end date, with demographics, statistical analysis, all events with causality, endpoint results, and any design changes. If you already produce a DSUR for a companion drug or combination product, map the Brazilian device tables into an annex. Do not file the DSUR and assume ANVISA has been served.

Pivotal high-risk (Class III/IV) designs are expected to constitute a data-monitoring committee. Recommendations go to ANVISA as a DICD addendum within 30 calendar days of the sponsor receiving them. An FIH that is not labeled “pivotal” can still justify a DMC on risk. Write that justification in the plan before first patient, including why you did not constitute one.

What must stay aligned if the FIH will later support FDA

FDA device investigations do not use the IND SUSAR clock. They use unanticipated adverse device effect (UADE) rules under 21 CFR 812.150. An investigator reports a UADE to the sponsor and reviewing IRB as soon as possible, and no later than 10 working days after first learning of it. The sponsor evaluates immediately and reports the evaluation to FDA, all reviewing IRBs, and participating investigators within 10 working days of first notice. If the UADE presents an unreasonable risk, termination clocks in 21 CFR 812.46 are 5 working days from that determination and 15 working days from first notice. FDA’s IDE FAQs repeat the same 10-working-day sponsor evaluation report.

Those clocks will not match Brazil’s 24-hour / 7-calendar / 15-calendar structure. Alignment is not “pick the longer one and hope.” Alignment is a single source narrative:
- One event identifier from the Brazilian CRF code through NotivisaEC and, if an IDE exists or will exist, through the UADE file.
- One expectedness baseline — the same brochure version cited in the DICD and in the IDE investigational plan. If Brazil updates the brochure after an unexpected event (RDC 837/2023 requires investigators to be informed and the brochure to be updated), send that version into the FDA file in the same week.
- One causality sentence that a device reviewer recognizes (device, procedure, disease, concomitant product). Do not let the Brazilian form say “possible” and the IDE memo say “unrelated” without a dated reconciliation.
- Device identifiers — lot, serial, software version, accessory — on every case. Import traceability under the DICD DOU number is the same data FDA will ask for when the unit later supports a 510(k), De Novo, or PMA.
- Quality-system evidence that the investigational unit was built under a system you can defend as you move toward the QMSR. A NotivisaEC case that cannot find the device history record is already a future FDA inspection finding.
If there is no U.S. IDE yet, still write Brazilian cases as if 812.150 will apply later. Reconstructing UADEs from a drug-safety database two years on is how FIH datasets lose credibility.

Where programs actually break

The bottleneck is rarely the web form. It is the weekend between the PI’s 24-hour email and a U.S. medical monitor who is still arguing expectedness against an old brochure. Build a Brazil on-call roster that can file NotivisaEC without waiting for California business hours. Give the Brazilian authorized representative and the ORPC (if one is the DICD face) read-only access to the safety tracker. Import holds, ethics queries, and ANVISA inspections all ask for the same case list.

Second break: treating CEP notification and ANVISA notification as the same send. Law 14.874/2024 sends serious events to the CEP. RDC 837/2023 sends a narrower unexpected-and-related set to ANVISA on NotivisaEC. Your SOP should have two lines, two clocks, two receipts.

Third break: annual-report amnesia. The 60-day secondary petition is how ANVISA sees aggregate harm. If your data-management lock cannot produce site-level AE tables from Brazilian CRF codes, you will miss a petition that can cancel the DICD — after first patients are already in.

A practical next step

Before site initiation, run one tabletop: a fatal unexpected device-related event at 18:00 Brasília on a Friday. Walk the 24-hour investigator notice, the 7-calendar-day NotivisaEC filing, the 8-day follow-up, the CEP notice under Law 14.874/2024, the brochure update, and — if an IDE is live or planned — the 10-working-day UADE evaluation to FDA. If any of those hands is “we’ll figure it out,” rewrite the safety SOP and name the NotivisaEC filer. First-patient week is the wrong time to discover that VigiMed was the only account anyone opened.
August 22, 2026
ANVISA medical device classification rules for FIH studies in Brazil
Most first-in-human (FIH) delays I see in Brazil do not start on the ANVISA clock. They start earlier, when regulatory affairs treats class as a registration afterthought instead of the decision that decides whether you even file a clinical investigation dossier, what the import petition can carry, and what the investigator brochure must treat as expected.

This is not another walkthrough of Brazil’s 90-day ANVISA review window, and it is not a recap of Law 14.874/2024. Those calendars matter, but they sit on top of a classification call. If that call is wrong, the clock you are watching is the wrong clock.

RDC 751/2022 is the class rule, not a slogan

Collegiate Board Resolution RDC No. 751 of 15 September 2022 is ANVISA’s current framework for medical-device risk classification, labeling and instructions for use, and the notification versus marketing-authorization (registro) regimes. Article 5 places devices in four intrinsic-risk classes:
- Class I — low risk
- Class II — medium risk
- Class III — high risk
- Class IV — maximum risk
Articles 6 and 7 then split the premarket path: Classes I and II are subject to notification; Classes III and IV are subject to marketing authorization. ANVISA’s English overview of the same split is on the Agency’s medical devices page.

Classification is not a marketing preference. It is a rules exercise against the manufacturer’s intended purpose. Annex I of RDC 751/2022 sets the classification rules (duration of use, invasiveness, active energy, implants, special rules). The most stringent applicable rule wins. Software as a medical device is classified on its own intended purpose when it is standalone. In vitro diagnostic devices sit on a separate IVD classification track; do not force an IVD into the same clinical-investigation box as an implant.

For an FIH program, lock three statements in the same document: intended purpose in Portuguese that will appear on the DICD and later on the registro file; the Annex I rule (or rules) you applied; and the resulting Class I–IV. If clinical, quality, and the Brazilian authorized representative cannot repeat those three lines without hedging, you are not ready to talk about first-patient dates.

RDC 10/2015 is not the current FIH filing rule

Sponsors still arrive with “RDC 10/2015” in the regulatory plan. That resolution existed. It is not the current device-investigation statute.

RDC No. 548 of 30 August 2021 revoked RDC No. 10 of 20 February 2015 (Article 84 of RDC 548/2021). RDC No. 837 of 13 December 2023 then replaced that 2021 text. ANVISA announced the update and the alignment with international practice in its 18 December 2023 notice (in force early January 2024). Article 80 of RDC 837/2023 revokes RDC 548/2021.

Current device clinical-investigation procedure is RDC 837/2023. Use RDC 10/2015 only as history. Do not cite it as the filing basis for a 2026 FIH.

How class drives whether you file a DICD

RDC 837/2023 is explicit about scope. A Dossiê de Investigação Clínica de Dispositivo Médico (DICD) is required for clinical investigations involving Class III or Class IV devices that are not yet registered in Brazil. A registered device studied for an indication different from the indication in the sanitary registration also goes in as a DICD.

The same resolution carves out investigations that do not go to ANVISA as a DICD, including:
- clinical performance studies of IVDs;
- usability/human-factors-only studies (unless the clinical investigation also includes those endpoints among others);
- investigations of devices already registered in Brazil for the same approved indications;
- clinical investigations of Class I or Class II devices.
Class I and II investigations are still expected to follow good clinical practice. RDC 837/2023 points to the Document of the Americas and ISO 14155 as the GCP standard. They still need ethics approval. They do not get a free pass on import controls or on manufacturing quality of investigational units. What they do not get is a DICD as the ANVISA on-ramp.

That is the classification bottleneck. A U.S. significant-risk implant that an RA lead quietly “simplifies” to Class II to avoid a dossier is not a timeline win. It is a first-patient hold when import, ethics, or a later registro reviewer asks why the intended purpose looks like Rule 8 (long-term surgically invasive / implant) and the file says Class II. The opposite error is also expensive: forcing a true Class II tool through a DICD because someone copied a Class III playbook wastes petition fees and a review cycle you did not owe.

What the DICD actually has to carry

When class puts you in DICD scope, RDC 837/2023 consolidates the old two-dossier habit into one submission. The petition typically includes the DICD form, the sanitary-surveillance fee (GRU) or exemption, the investigator brochure, a safety-experience summary (prior human use and any foreign post-market experience), the investigational-device dossier, the clinical investigation plan under GCP, and proof of registration in a WHO ICTRP or ICMJE-recognized trial registry (or that proof at start-date notification if it is not ready at first protocolization).

ANVISA’s petition checklist for DICD subject 80104 is published in the Agency’s SAT instruction list. Use that list, not a recycled IND table of contents.

Two operational rules from the same resolution save weeks if you lock them before translators start:
- The party who files the DICD owns every later secondary petition. Do not let a consultant file “just this once.”
- An organização representativa de pesquisa clínica (ORPC) may file only when the sponsor has no headquarters or branch in Brazil. If you already have a Brazilian legal presence, that presence is the face of the file.
RDC 837/2023 gives ANVISA 90 calendar days (dias corridos) to issue a manifestation on the DICD, with a tacit-start path after ethics approval if the Agency is silent. Law 14.874/2024 Article 58 speaks of 90 business days (dias úteis) for primary sanitary analysis of clinical-trial petitions intended to support registration. Those are not the same unit of time. Treat the mismatch as a planning flag; do not invent a hierarchy in a slide. The clock posts already cover activation math. Classification decides whether that math applies to you at all.

Import, IOR/AR, and QMSR sit on the same class decision

Investigational units do not enter Brazil on a commercial registro. RDC 837/2023 Chapter IX puts exclusive clinical-use import under sanitary inspection and SISCOMEX release. The importer must cite the Diário Oficial da União resolution number for the DICD grant. Outer packaging must carry that DOU number, storage conditions, and a lot, identification, or serial code that can trace the unit. Quantities are limited to what the investigation needs. Commercialization of those units is prohibited.

If someone other than the DICD holder imports, both parties sign a delegation-of-import-responsibility document. That is your import authorized representative problem, not a freight problem. The same legal person who will later hold notification or registro as authorized representative should see the investigational import list now. A first-patient kit that is not on the DICD product list will sit on the dock.

On quality: RDC 837/2023 requires investigational devices, and any placebo or sham, to be manufactured to good manufacturing practice and labeled so they are identifiable as investigational. ANVISA may inspect the manufacturing site against the technical, production, and quality-control story in the DICD. If the same design will later support an FDA marketing file, build those units under the quality system you intend to defend — including the United States Quality Management System Regulation transition — not under a “prototype exception” that you cannot reconstruct.

What the RA lead must lock before first patient

Write these eight items as a one-page gate. Do not open the site until each line has an owner and a document ID.
1. Intended purpose. The Portuguese indication that will classify the device under RDC 751/2022 Annex I and that will appear in the investigator brochure. Changing “long-term implant” to “intraoperative aid” after ethics approval is a new class, not a wording tweak.
2. Class and rule. Class I–IV plus the governing Annex I rule. Record why neighboring rules were rejected.
3. DICD yes/no. Apply RDC 837/2023 Articles 2 and 4. Class I/II, same-indication post-market, IVD performance, and usability-only studies are out of DICD scope. Class III/IV unregistered, and new indications on a registered device, are in.
4. Filing face. Sponsor legal entity in Brazil versus ORPC. Name the person who will own secondary petitions: start/end dates, amendments, annual report.
5. Import list. Every investigational SKU, spare, and accessory that will clear SISCOMEX, mapped to the DICD form. No “we’ll add the introducer later.”
6. Expectedness language. The brochure and operator manual define “unexpected” for later safety notification. If the FIH protocol lists risks the brochure omits, you have built a 7- and 15-day reporting trap.
7. Ethics path. CEP submission under Law 14.874/2024 in parallel with, not after, the sanitary file when a DICD is in scope. Single-CEP review for multicenter protocols is a legal design, not a courtesy.
8. Start-date discipline. RDC 837/2023 requires start- and end-date forms as secondary petitions within 30 calendar days of each Brazil date. First patient is a regulatory event, not only a clinical one.
Amendments after that gate are expensive. Substantial changes to the brochure or device dossier that can affect quality or safety wait for ANVISA manifestation (again, 90 calendar days in RDC 837/2023). Substantial protocol amendments that affect participant safety or scientific value wait the same way, except amendments that remove an immediate risk, which you implement and notify. Classification mistakes tend to surface as those amendments.

A practical next step

This week, run a 90-minute classification huddle with RA, clinical, quality, and the Brazilian representative. Put the intended-purpose sentence, the Annex I rule, the Class I–IV result, and a yes/no DICD decision on one page. Attach the RDC 751/2022 English text and the RDC 837/2023 scope articles. If those four people cannot sign the page, do not book first-patient week. The calendar you save is not ANVISA’s — it is the month you would have spent unscrewing a class you never locked.
August 22, 2026

Tag: regulatory strategy

What changed since 2022

The device pathway: prototype authorization through pivotal

The drug pathway

Timelines, and what the misconception gets wrong

Sites: Bogotá, Medellín, Cali

Ethics committees

Post-trial access in Colombia

What is coming, and why it favours moving now

Registro Sanitario sits at the far end of the same pathway

Frequently asked questions

Sources

Why the paperwork carries more weight than the filing

Pillar 1: the Safety Data Exchange Agreement

Pillar 2: the Data Processing Agreement — country by country

The Argentina adequacy mistake

Pillar 3: product liability sits with the sponsor

Pillar 4: sponsor accession as a condition precedent

Five architectural mistakes we see repeatedly

Governing law, dispute resolution, and pre-send gates

Frequently asked questions

Sources

The obligation: Article 115 and Article 40(p)

Who pays

Devices are in scope

Two authorization routes under Article 116

Article 117: the seven-document set

Import, dispensing and product handling

Timelines that are actually in the regulation

Pharmacovigilance after access begins

Stability of the pathway

Frequently asked questions

Sources

What Ley 20.850 actually did

What Article 111 C requires

Devices are expressly in scope

The obligation follows the registration, not the sponsor

Where the ISP fits

CENABAST and the exceptional-import backstop

The Ricarte Soto Fund as the exit ramp, and its limits

What the statute leaves open

Frequently Asked Questions

Sources

What the statute actually requires

Article 31 of the Decreto: the operative sentence

Who pays, and for how long

Devices and advanced therapies are in scope

CEP, ANVISA and INAEP: three approvals, three functions

The import mechanism

What this means for a sponsor’s budget

Frequently asked questions

Sources

The obligation and the import route live in two different instruments

What Disposición 12792/2016 covers — and what it excludes

The Article 3 dossier: eight documents, filed before study close

Article 3(h) and the habilitación question

Article 4: twelve months, per investigator and center

Article 5: how the product physically enters

What this route is not: RAEM and expanded access

What changed on 1 December 2025

Data protection for the follow-up data

Timeline reality

Frequently asked questions

Sources

What Decreto Ejecutivo 21/2026 actually is

Article 68 verbatim

Investigators and sponsors are co-obligated

Duration: until commercialization in Panama

The extension of the import permit

RESEGIS, the DNFD and the CBI

What Article 104 repealed — and what it did not

Misconceptions worth correcting

What sponsors should do before database lock

Frequently asked questions

Sources

Introduction

EU MDR Classification System Overview

Key Regulatory Requirements for Class 2b Medical Devices

Clinical Evidence and Performance Standards

Conformity Assessment Procedures for Class 2b Devices