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Tag: first-in-human

  • 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

  • Brazil Clinical Research Completeness Check: The Ethics Acceptance Handoff for LATAM MedTech Studies

    Brazil Clinical Research Completeness Check: The Ethics Acceptance Handoff for LATAM MedTech Studies

    For a MedTech sponsor, submitting a study in Brazil is not the same as starting the review clock. The practical milestone is acceptance of a complete, internally consistent package by the responsible ethics and regulatory reviewers. Missing translations, mismatched device descriptions, unsigned site documents, or an unresolved import assumption can turn a promising first-in-human or early-feasibility plan into a sequence of avoidable clarification cycles.

    A disciplined completeness check is therefore more than an administrative exercise. It is the handoff that converts product development evidence into a reviewable clinical study, while creating a template that can be adapted for Colombia, Mexico, Peru, and other Latin American markets.

    Why the ethics acceptance handoff deserves its own control

    MedTech submissions often fail operationally at the boundary between functions. Regulatory colleagues may work from the latest technical dossier, clinical teams from a revised protocol, and the study site from an older informed-consent form. Each document can look reasonable on its own while the package tells different stories about intended use, patient eligibility, procedure steps, adverse-event management, or follow-up.

    Reviewers usually encounter those differences before the sponsor does. The result may be a request for clarification, a pause while the site confirms capabilities, or a need to retranslate and reapprove participant materials. In an early-stage study, even a short delay can affect investigator availability, equipment scheduling, import planning, and the sponsor’s evidence-generation sequence.

    The handoff should answer one question: can an independent reviewer understand what will happen to which participant, with which investigational device, at which qualified site, and under which safeguards without asking the sponsor to reconstruct the story?

    Build one source of truth before country tailoring

    Start with a controlled study narrative and a document matrix. The narrative should state the device’s intended use in the study, the target population, the procedure, the learning objectives, the known and foreseeable risks, and the stopping or escalation rules. Every country document should be checked against that narrative before translation or submission.

    The matrix should identify the owner, version, approval status, language, and submission destination for at least:

    • Protocol, synopsis, statistical or analysis plan, and risk-management summary.
    • Investigator brochure or device dossier, including configuration, accessories, software version, labeling, and instructions for use.
    • Informed-consent form, participant information sheet, recruitment materials, and compensation language.
    • Investigator qualifications, site facilities, procedure-room controls, emergency coverage, device accountability, and training records.
    • Insurance, indemnity, local representation, data-protection documents, and safety-reporting procedures.
    • Import, customs, storage, calibration, maintenance, and return or destruction instructions for investigational units.

    The objective is not to submit every possible document. It is to prove that the selected documents are sufficient, current, and mutually consistent for the study risk and the reviewing institution.

    A five-gate completeness check for Brazil and LATAM

    Gate 1: identity and version lock. Confirm that the protocol, device description, risk analysis, consent materials, and investigator-facing documents use the same product name, configuration, intended use, and version identifiers. Record the effective date and archive superseded files.

    Gate 2: participant-facing clarity. Test the local-language consent materials with someone who was not involved in drafting them. The text should explain the investigational nature of the procedure, alternatives, foreseeable risks, follow-up, data use, and withdrawal without introducing promises that are absent from the protocol. Reconcile terminology across Portuguese, Spanish, and English source files where a multi-country program is planned.

    Gate 3: site capability evidence. Do not rely on a general hospital profile. Map each protocol-critical step to a named room, trained role, piece of equipment, emergency pathway, sample or image workflow, and backup plan. If a capability is supplied by a neighboring department or external service, document the handoff and availability window.

    Gate 4: logistics and accountability. A device can be clinically ready and still be operationally unavailable. Check importer-of-record responsibilities, shipping documents, storage conditions, serial-number control, calibration, delivery receipt, quarantine, return, and destruction. The same device identity should appear in the dossier, site log, shipment plan, and accountability form.

    Gate 5: query ownership and acceptance evidence. Before filing, assign an owner and response target to every foreseeable question. Maintain a redline log showing what changed after internal review, who approved it, and whether the change affects the protocol, consent, risk assessment, site training, or country annex. Save the acceptance notice and the exact package that was accepted; do not treat a later working draft as the official baseline.

    Turn completeness into a measurable activation advantage

    Track more than submission date. Useful indicators include first-pass completeness, number of clarification cycles, days from query receipt to coordinated response, percentage of documents translated without terminology rework, and the time from acceptance to site readiness. These measures reveal whether a delay is regulatory, clinical, logistical, or simply caused by version control.

    For a regional program, keep a master package and add country annexes for local ethics language, authority forms, importer arrangements, insurance, and site requirements. That approach preserves a consistent safety story without assuming that one country’s acceptance substitutes for another’s. It also makes lessons from the first submission reusable instead of forcing the sponsor to restart document reconciliation for every market.

    The strongest Brazil submission is not the longest one. It is the one in which reviewers, investigators, and participants can see the same study from their respective perspectives. Treating ethics acceptance as a controlled handoff—rather than a ceremonial checkpoint—helps a leading MedTech startup protect its timeline, reduce rework, and generate evidence that remains credible across Latin America.

    Frequently asked questions

    What does “complete” mean for a Brazil MedTech submission?
    It means the reviewing body has the documents and information needed to begin substantive review, with consistent product, protocol, participant-protection, site, and logistics information. Exact requirements depend on the study and reviewing institutions.

    Should the sponsor translate every technical document?
    Translate what reviewers, investigators, and participants must read in the required local language, while maintaining controlled source versions for technical review. Confirm language expectations early rather than translating after a deficiency notice.

    Can the same completeness checklist be used in other Latin American countries?
    Yes, as a master control. Keep the core evidence consistent, then add country-specific authority forms, ethics requirements, local representation, import documents, and site controls instead of assuming identical procedures.

  • 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.

  • 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.

  • First-in-Human Trial Readiness in Latin America: The Cross-Functional Gate Before Submission

    First-in-Human Trial Readiness in Latin America: The Cross-Functional Gate Before Submission

    A first-in-human (FIH) study in Latin America can move quickly only when the sponsor’s evidence tells one consistent story. The protocol, risk analysis, investigator brochure or device dossier, informed-consent materials, ethics package, and import plan must describe the same intended use, population, procedure, and safeguards. If those documents drift apart, a fast regulatory pathway can turn into a long clarification cycle.

    Internal experience across early-stage programs shows that readiness is less about producing more pages and more about closing the handoffs between regulatory, clinical, quality, site, and supply-chain teams. This practical gate helps MedTech founders and regulatory directors test whether a study is ready for country submissions without relying on a single calendar estimate.

    1. Start with one study story

    Before country tailoring begins, write a concise study narrative that every contributor can use. State what the investigational device is, who will use it, for which patients, in what setting, and what the FIH study is designed to learn. Separate proof-of-principle or early-feasibility questions from claims that will require a later pivotal study or market authorization.

    Then link each major claim to evidence. A risk control in the technical file should appear in the protocol’s monitoring plan and, where relevant, in the training and consent materials. The primary endpoint should match the feasibility objective. The procedure described for the investigator should match the version assessed by the ethics committee. This simple traceability exercise exposes contradictions before an authority or committee has to ask about them.

    • Intended use: define the population, setting, operator, procedure, and boundaries of use.
    • Risk controls: show foreseeable hazards, mitigations, stopping rules, and escalation contacts.
    • Clinical objective: use a focused endpoint set that answers the early-stage question without promising more than the study can demonstrate.
    • Participant protection: connect eligibility, follow-up, adverse-event handling, and consent language to the risk profile.
    • Version control: maintain one controlled source for device specifications, protocol revisions, and country annexes.

    2. Map the regulatory and ethics lanes before filing

    Latin America is not one regulatory pathway. A country matrix should identify the competent authority, ethics route, submission format, required translations, import documentation, responsible local party, and the definition of a complete submission. It should also distinguish a statutory or published review period from a practical activation forecast that includes clarifications, contracts, training, and shipment.

    Brazil illustrates why this distinction matters. Law No. 14.874/2024 establishes a 30-business-day period for an ethics committee to issue its opinion after accepting a complete document set, and a 90-business-day ceiling for the health analysis of primary clinical-trial petitions covered by the law. Those provisions are useful planning inputs, but they do not eliminate sponsor work before acceptance or operational work after authorization. The official English translation of Law No. 14.874/2024 should be checked for scope and the current implementation context.

    Colombia requires a different document conversation. INVIMA’s clinical-investigation materials identify the technical and ethical information needed for medical-device studies and publish current forms for protocol evaluation, ethics-committee assessment, notifications, and periodic reports. The sponsor should confirm the latest checklist rather than reusing a prior country’s format. The INVIMA clinical-investigation page is the appropriate starting point for current requirements.

    3. Treat site and import readiness as submission evidence

    An approved protocol cannot enroll if the site cannot perform the procedure, protect participants, or receive the investigational product. Site feasibility should therefore be documented before submission, not treated as a post-approval procurement task. Confirm investigator experience, procedure volume, equipment, imaging or laboratory support, emergency coverage, data systems, and the site’s ability to meet the visit schedule.

    For an investigational device, also map the physical journey into the country. Identify the importer of record or other responsible local party, customs broker, shipping documents, product description, packaging, storage conditions, and receipt inspection. The receiving site should know who can release a shipment, where it will be stored, how it will be labeled, and how deviations will be documented. If those answers are missing, the regulatory package is operationally incomplete even when the PDF set looks finished.

    Use an owner-and-dependency map for each handoff. Regulatory owns the submission matrix; clinical owns protocol and endpoint consistency; quality owns controlled versions and deviation pathways; the site owns readiness evidence; and logistics owns import and delivery controls. A single accountable person should resolve conflicts rather than allowing parallel teams to submit different answers.

    4. Run a documented readiness gate

    Two weeks before the planned filing, hold a cross-functional gate with the country team and proposed site. The objective is not to read every page aloud. It is to test the few dependencies that can stop the study.

    • Traceability check: reconcile intended use, device configuration, endpoints, risks, and consent language across all core documents.
    • Completeness check: confirm forms, translations, signatures, fees, certificates, and local representative details for the target country.
    • Site check: verify staff training, equipment, standard operating procedures, safety escalation, and recruitment assumptions.
    • Import check: test the shipment dossier with the broker and receiving site before the first dispatch.
    • Clarification check: prepare an evidence map showing who will answer likely questions and how quickly.

    Record open items with an owner, due date, and submission impact. If a high-risk item is unresolved, move the filing date rather than hiding the issue inside an optimistic timeline. A short, coherent dossier usually creates more speed than a large dossier assembled in parallel without a common source of truth.

    Frequently asked questions

    What is the most common FIH readiness failure?
    Document inconsistency is a frequent failure: the protocol, device description, risk controls, and consent materials describe different versions of the study. A traceability matrix finds this before submission.

    Can a sponsor use the same dossier in every Latin American country?
    The scientific core can be reused, but country forms, translations, ethics routes, local responsibilities, and import rules require tailored annexes. Reuse controlled content; do not assume identical filing requirements.

    When should import planning begin?
    Begin during site selection and protocol planning. Shipment classification, local responsibility, customs documents, storage, and receipt procedures can affect the activation sequence and should be tested before authorization.

    For sponsors planning an early-stage MedTech study, the practical goal is a submission that regulators, ethics committees, investigators, and logistics partners can all execute from the same study story. That is the readiness gate that turns a promising FIH concept into a controllable Latin America launch plan.

  • INVIMA-Ready MedTech Dossier Checklist for First-in-Human Studies in Colombia

    INVIMA-Ready MedTech Dossier Checklist for First-in-Human Studies in Colombia

    For a leading MedTech startup, Colombia can be an attractive setting for a first-in-human or early-feasibility study. The opportunity, however, is not created by a single form or approval letter. It depends on whether the sponsor presents a coherent story about intended use, risk, clinical need, participant protection, and operational control.

    An INVIMA-ready dossier is therefore more than a document folder. It is a cross-functional quality system that allows the regulator, ethics committee, investigators, and import team to reach the same conclusion from the same evidence. The following checklist is designed for sponsors preparing an early-stage medical device study in Colombia. Requirements can change, so the current INVIMA forms and instructions should always be confirmed before filing.

    1. Start with the intended use and risk story

    The first quality gate is a short, precise statement of what the device is intended to do in the study and what the study is not designed to prove. Define the target population, clinical setting, operator, use procedure, expected benefit, and foreseeable hazards. Then connect each claim to a source of evidence.

    This discipline prevents a common early-stage problem: the protocol describes a feasibility objective, while the technical file reads like a marketing submission. A first-in-human dossier should be candid about uncertainty and show how the investigation will manage it.

    • Define the study purpose: distinguish feasibility, initial safety, usability, and exploratory performance objectives.
    • Map the risk profile: link hazards and mitigations to the risk-management file and to monitoring activities.
    • Clarify the use environment: describe the procedure, training assumptions, accessories, maintenance, and conditions that could affect performance.
    • Identify evidence gaps: explain which questions require clinical data because bench testing, literature, or comparable-device information is insufficient.

    2. Build the Colombia-specific submission core

    INVIMA’s clinical-investigation resources identify the GICASE group and publish current forms and checklists for medical-device studies. The page references Resolution 8430 of 1993 as the general framework for research involving human beings and lists a checklist for technical-concept requests involving prototype medical-device protocols and associated documents. Sponsors should use the current version of that checklist as the filing backbone rather than relying on a generic global template.

    The dossier should be assembled as a controlled set of modules, with an index that makes review easy:

    • Protocol and synopsis: objectives, design, population, eligibility criteria, endpoints, follow-up, stopping rules, statistical rationale, and deviation handling.
    • Device and technical file: description, intended use, design overview, manufacturing controls, verification and validation results, software or electrical documentation where relevant, labeling, instructions for use, and traceability.
    • Risk and clinical justification: risk analysis, residual-risk assessment, literature or comparable-device evidence, known limitations, and a clear explanation of why the proposed study is proportionate to the remaining uncertainty.
    • Participant protection: informed-consent materials, participant information, privacy safeguards, compensation or treatment arrangements, insurance documentation where applicable, and safety-reporting procedures.
    • Site and investigator package: qualifications, facilities, equipment, training, delegation, recruitment plan, monitoring approach, and the ethics committee pathway.

    Use a document matrix to show where each requirement is answered. If a requirement is not applicable, state why and identify the supporting rationale. An unexplained blank looks like an omission; a documented rationale shows control.

    3. Treat ethics, imports, and site readiness as one workstream

    Regulatory submission is only one part of activation. A technically complete dossier can still lose time if the ethics committee receives a different protocol version, the site is not trained on the final instructions, or the investigational shipment cannot be cleared. Sponsors should manage these dependencies in a single readiness plan.

    • Synchronize versions: the protocol, consent form, investigator materials, labels, and training deck should use the same device description, risks, endpoints, and amendment status.
    • Prepare the ethics package early: confirm committee submission windows, local language needs, investigator signatures, participant-facing readability, and the process for reporting serious adverse events.
    • Plan import readiness: confirm the responsible local party, customs documentation, product classification, declared value, packing list, serial or lot traceability, storage conditions, and return or destruction process.
    • Test site execution: rehearse device receipt, quarantine, accountability, calibration or setup, troubleshooting, use, cleaning, and post-procedure documentation before the first participant visit.

    This approach also improves responses to information requests. When a reviewer asks how a risk is controlled, the sponsor can point to the same control in the technical file, protocol, training record, and monitoring plan.

    4. Run a sponsor-side quality-control gate

    Before filing, conduct a structured review that is independent of the person who assembled the first draft. The goal is not to make the dossier longer. It is to eliminate contradictions that create avoidable clarification cycles.

    • Compare the device name used internally with the generic description used in participant materials and shipment documents.
    • Reconcile every primary and secondary endpoint with the analysis plan, case-report forms, and monitoring metrics.
    • Check that every residual risk has a mitigation, a participant-facing disclosure, and a safety signal or escalation pathway.
    • Verify that investigator responsibilities, sponsor responsibilities, and vendor responsibilities are explicit.
    • Confirm that translations preserve technical meaning and that the controlled English master is traceable.
    • Prepare a response log with an owner, due date, evidence reference, and final approval for each question.

    The best dossier is not the one with the most pages. It is the one a reviewer can navigate quickly, understand without inference, and assess against the study’s actual risk. For a leading MedTech startup, that clarity is a competitive operational advantage: it protects participant safety while reducing rework across regulatory, ethics, clinical, and logistics teams.

    FAQ: INVIMA-ready MedTech dossiers

    Does a global clinical-investigation package need a Colombia-specific adaptation?

    Yes. A global core can reduce duplication, but the sponsor still needs a Colombia-specific regulatory and ethics annex. Adapt the local forms, language, responsible parties, participant materials, import plan, and explanations of how foreign evidence applies to the Colombian setting.

    When should import planning begin?

    Begin during protocol and site planning, not after approval. Classification, local responsibility, documentation, storage, and return or destruction decisions can affect the feasibility of the study and should be reflected in the operational plan.

    What is the most common avoidable dossier weakness?

    Inconsistency. Differences in device description, endpoint definitions, risk language, document versions, or responsibilities create questions that are preventable with a cross-document matrix and an independent quality-control review.

  • A Practical Regulatory Timeline For First-In-Human Medical Device Studies In Latin America (2026)

    A Practical Regulatory Timeline for First-in-Human Medical Device Studies in Latin America (2026)

    For MedTech founders and regulatory directors, Latin America can be the fastest path to a first-in-human (FIH) medical device milestone—if you treat timeline as an operational deliverable, not a hope. The region is not a single market: documentation, ethics review cadence, import steps, and contract mechanics vary by country and by whether your study is observational, non-significant risk (NSR), or significant risk.

    This article provides a practical way to plan an FIH device study timeline across Latin America in 2026: what workstreams to run in parallel, where delays typically occur, and how to de-risk your critical path without compromising compliance or participant safety.

    1) Start with a “workstream map,” not a single Gantt chart

    FIH device studies commonly stall because sponsors build one linear plan when the reality is a set of interdependent workstreams. A useful planning framework separates your launch into seven workstreams, each with its own owners, documents, and review cycles:

    • Protocol package (protocol, IB/IFU, risk analysis, monitoring plan, DSMB plan if needed)
    • Country regulatory submission (device classification/route, authority forms, translations, legalization requirements if any)
    • Ethics approval (central/local IRB/ethics committee workflow, consent language, recruitment materials)
    • Site contracting & budgets (CTA, indemnification, insurance certificates, payment triggers)
    • Import & logistics (shipping lanes, customs broker readiness, temp-control, labeling)
    • Site activation (SIV readiness, staff training, device accountability tools)
    • First patient in (FPI) (screening plan, recruitment levers, backup sites)

    When these workstreams are run deliberately in parallel, many sponsors can compress timelines materially versus the “submit, wait, then do the next thing” approach.

    2) A realistic 2026 timeline template (what to do in each month)

    Every program differs, but for early-feasibility or FIH device studies, a practical timeline template often looks like this:

    • Weeks 0–2: Feasibility + site shortlist. Confirm patient pool, investigator interest, imaging/lab capabilities, and whether your endpoints are standard-of-care in that setting.
    • Weeks 1–4: Submission-ready document set. Build the “country-ready” version of the protocol package: consistent terminology, device description aligned with IFU, and localized consent templates.
    • Weeks 3–8: Parallel ethics + regulatory preparation. Prepare authority-specific forms while the ethics packet is being finalized; do not wait for final contracts to start regulatory readiness.
    • Weeks 6–12: Contracts, budgets, and insurance. In many countries, the slow step is not scientific review but the negotiation of indemnification clauses, invoice rules, and insurance wording.
    • Weeks 8–14: Import and first shipment readiness. Align labeling, airway bills, and broker processes early; confirm whether your device is shipped as commercial goods, samples, or study materials and plan accordingly.
    • Weeks 12–18: SIV + site activation. Execute training, device accountability procedures, and data capture dry runs.
    • Weeks 16–24: FPI window. A strong screening plan and backup sites protect you from “approval achieved, recruitment delayed.”

    Rather than treating “approval” as the finish line, treat it as the midpoint: you still need operational readiness to reach FPI.

    3) Where timelines slip (and how to protect the critical path)

    Across Latin America, recurring delays tend to cluster into a few categories:

    • Translation and document consistency issues. Inconsistencies between protocol, IFU, and consent language trigger rework during ethics review.
    • Contract sequencing mistakes. If you wait for final CTA language before starting budget alignment or insurance certificates, you create avoidable idle time.
    • Import readiness left too late. Even when the device is low-risk, shipments can be rejected if labeling, documentation, or declared values are unclear.
    • Over-reliance on a single site. A single high-performing hospital is not a recruitment strategy; build a backup shortlist early.

    Two simple practices prevent many timeline slips: (1) run a weekly “document control” check to keep all versions synchronized, and (2) hold a pre-import readiness call with your broker and study team before any shipment is booked.

    4) Country selection: choose based on constraints, not hype

    Latin America offers multiple attractive options, but the best country for your FIH study depends on constraints:

    • Need speed? Prioritize clear ethics pathways, experienced investigators, and predictable import lanes for study materials.
    • Need specific patient phenotypes? Choose where that patient population is concentrated and where endpoints align with standard clinical practice.
    • Need imaging or specialized procedures? Ensure site infrastructure and maintenance/QA standards can support your device and endpoints.

    A practical rule: pick the country where your operational bottleneck is easiest to solve. If your bottleneck is import complexity, choose the market where your logistics and broker experience is strongest. If your bottleneck is investigator capability, choose the market with the deepest specialty network.

    FAQ

    • How long does an FIH device study typically take to reach first patient in (FPI) in Latin America?
      Many sponsors plan a 4–6 month window from kick-off to FPI when workstreams run in parallel, but timelines depend on device risk, required reviews, contracting speed, and import readiness.
    • What is the most common avoidable delay?
      Contracting and insurance language misalignment, followed closely by late import readiness and inconsistent translated documents.
    • How can sponsors reduce timeline risk without cutting corners?
      Use a workstream map, keep document versions synchronized, and build redundancy (backup sites, backup shipping lanes, and a recruitment contingency plan).

    Bottom line: In 2026, sponsors that treat Latin America FIH timelines as an integrated regulatory-and-operations program—rather than a single “submission” event—can reach FPI faster and with fewer surprises.

  • Brazil’s 90 Day Clinical Trial Review Cap: What Medtech Sponsors Should Do Before Submitting

    Brazil’s 90-Day Clinical Trial Review Cap: What MedTech Sponsors Should Do Before Submitting

    Brazil has moved from being a “high-potential but unpredictable” country for early-stage MedTech studies to a jurisdiction with a defined statutory review clock. For sponsors, that shift is not just a speed story — it is a planning story. When review timelines become shorter and more predictable, the relative impact of preventable sponsor-side errors gets larger.

    This article is written for MedTech founders, clinical operations leaders, and regulatory directors who want to run first-in-human (FIH) or early feasibility work in Brazil without losing weeks to rework. We focus on what you can control before submission: dossier readiness, ethics strategy, local operational prerequisites, and vendor orchestration.

    Why a faster regulatory clock changes the sponsor playbook

    Short timelines compress decision-making. If you used to “fix it after ANVISA feedback,” you may no longer have that luxury — because site contracts, import permits, radiology workflows, and ethics committee coordination can become the rate-limiting steps. A faster clock also forces clearer internal governance: who owns the final protocol, the risk assessment, the device technical file, and the country-specific annexes?

    Practically, the sponsor question becomes: How do we arrive at Day 0 with no missing pieces? The goal is to avoid pauses caused by translation gaps, document format mismatches, incomplete investigator packages, or unaligned device documentation.

    Pre-submission checklist: what to lock down before Day 0

    • Protocol version control: Confirm the final protocol, synopsis, schedule of assessments, and statistical plan are aligned — and that the same versions appear in every submission component.
    • Risk classification and device description: Ensure the device description, intended use, instructions for use, and risk analysis are consistent across documents. Inconsistency is one of the most common sources of questions.
    • Investigator and site packages: Collect CVs, training evidence, GCP documentation, and site capabilities early. In Brazil, the operational readiness of sites can become as important as the regulatory dossier.
    • Translations and local formatting: Build time for Portuguese localization and formatting checks. A strong translation is not only linguistic — it must preserve clinical meaning and match annex references.
    • Informed consent strategy: Prepare consent language that is clear, compliant, and aligned to local norms. If your device includes software, connectivity, or data transfer, incorporate that into consent and data handling text.
    • Import and logistics planning: Map the path for device shipment, labeling, and storage. Even for non-radioactive devices, customs, temperature needs, and distribution responsibilities can derail timelines.

    Parallel ethics + regulatory review: how to operationalize it

    When a system allows parallel tracks, the bottleneck often shifts to coordination. Sponsors should treat ethics submission as a project with its own critical path, not as an administrative afterthought. Build a unified submission calendar and align on:

    • Sequence of internal approvals: Decide who signs off on ethics content and who owns final responses.
    • Site-by-site variance: Even with a national framework, each site can introduce operational nuance. Standardize as much as possible, but plan for local adjustments.
    • Response management: Pre-write response templates for common questions (risk/benefit, recruitment strategy, device safety, data management) so you can move quickly.

    For FIH and early-stage work, ethics committees will often focus on patient protection and feasibility: training, emergency procedures, follow-up, and the practical ability of the site to manage adverse events. Your dossier should show readiness, not just compliance.

    What MedTech sponsors often underestimate in Brazil

    Speed-friendly frameworks do not eliminate complexity; they amplify the cost of under-planning. The most common underestimates include:

    • Data and privacy workflows: If your study uses digital endpoints or remote monitoring, align data flows, storage, and access controls early.
    • Device accountability: Plan how devices will be tracked, stored, returned, and reconciled. Accountability gaps create audit risk and can slow activation.
    • Training: Documented training is not optional in early-stage device studies. Build training into your timeline and capture evidence systematically.
    • Vendor interdependencies: CRO, imaging core lab, shipping/logistics, and local regulatory support must operate from the same timeline assumptions and document set.

    FAQ

    1) Does a statutory review cap guarantee approval in 90 days?
    No. A cap can improve predictability, but the practical timeline still depends on dossier quality, completeness, and how quickly questions are resolved.

    2) Should we treat Brazil as a first-choice country for FIH studies?
    Brazil can be compelling when the patient population, investigator expertise, and activation path fit the product. Sponsors should evaluate Brazil alongside other Latin American jurisdictions based on feasibility, ethics speed, and operational readiness.

    3) What’s the biggest sponsor-side mistake?
    Submitting with misaligned documents (protocol vs. device description vs. risk file) and assuming issues can be fixed “during review.” In faster systems, that approach often costs more time, not less.

    Bottom line: If your goal is to capture the benefit of a faster review framework, your work starts well before Day 0. A sponsor-side checklist — executed early — is often the difference between a fast approval and a slow cycle of preventable questions.

  • $8 Billion Of Pharma Capital Just Pointed At Argentina. What Medtech Founders Should Take From The May 29 CAEME Announcement.

    On May 29, 2026, the Cámara Argentina de Especialidades Medicinales (CAEME) announced jointly with President Javier Milei a six-year clinical research investment commitment from seven multinational pharmaceutical companies: Pfizer, Merck, Roche, Novartis, BMS, GSK, and Sanofi. The total commitment is USD 8 billion through 2032. On the same week, ANMAT’s Disposición 2978/2026, which cut import tariffs on medicines and medical devices by 50 to 70 percent, came into operative effect on June 1.

    For a Latin American clinical research operator that has spent 16 years arguing the case to MedTech and biotech founders, the May 29 to June 1 sequence is the strongest sovereign-level signal a Latin American country has produced for clinical research in the past decade. The data and the policy arrived in the same week. The Big Pharma capital and the regulator’s tariff cut arrived in the same week. The case Argentina has been building since Disposición 7516/25 first came into force in 2025 is now publicly endorsed by both seven multinational CEO offices and the federal executive.

    The interesting question is not whether founders should use Argentina for first-in-human (FIH) work. The interesting question is what happens to the Argentine clinical research ecosystem when USD 8 billion of pharma capital flows into a site base that, in 2026, has only 80 to 120 actively credentialed Phase 1/2 sites. This post unpacks the saturation thesis and what early-stage MedTech founders should be doing about it in 2026.

    The Site Saturation Math

    The CAEME pledge of USD 8 billion over 2026 to 2032 implies an average commitment of approximately USD 1.33 billion per year. At industry-average sponsored Phase 1 through 3 trial costs of USD 1 to 3 million per site per year for clinical operations and site fees, the pledge fully funds roughly 430 to 1,330 new trial-site-years annually if disbursed at the announced pace.

    Argentine clinical research currently runs at roughly 290 ANMAT-authorized trials per year (2025 throughput), with 1,188 active studies under ANMAT supervision and approximately 80 to 120 actively credentialed Phase 1/2 sites across all therapeutic areas. The pledge contemplates a 2.5x step-up in trial inflows against approximately the same site base.

    The implication is straightforward. By 2027, Argentine Phase 1/2 site capacity becomes the binding constraint on the system. Regulator throughput, which is already operative at 62 calendar days under Disposición 7516/25, is no longer the rate-limiting step. Site availability is. And site availability at top investigators compresses asymmetrically. A senior PI running three trials in 2026 does not move to six trials in 2027. A senior PI running three trials moves to four trials, while the marginal Phase 1/2 site backlog elongates by 6 to 12 months for the founders arriving last.

    Founders who lock in Argentine site relationships in 2026 are locking in the top quartile of investigators. Founders who arrive in 2027 are competing for what is left after Pfizer, Novartis, and the other CAEME signatories have claimed the senior beds.

    Why the Argentine Government Did This Now

    Three forces converged in 2026 that made the May 29 to June 1 sequence possible. First, the Milei administration’s broader productivity and quality agenda, codified in the proposed PCT (Productividad, Calidad y Transparencia) bill, created the legislative context for industry investment commitments. Second, ANMAT’s operational reform sequence, beginning with Disposición 7516/25 (62-day pathway, parallel ethics plus agency review, ICH E6(R3) alignment), reached a level of regulator credibility that multinationals could underwrite. Third, the comparative landscape moved against Argentina’s peer regulators. Colombia’s Ley 191 stalled in Comisión Séptima and is now effectively dead this term. Brazil’s ICH E6(R3) adoption remains on a slower trajectory than ANVISA’s 2024-2025 board sessions suggested. Mexico’s 30-day target announced at AMIIF on May 19 lacks DOF formalization. Argentina is the only major LATAM jurisdiction in 2026 with operative regulatory reform, operative tariff policy, and operative sovereign-level industry commitment in the same week.

    The PCT bill is the only caveat that matters. The CAEME pledge is contingent on PCT passage. As of June 1, the bill remains stalled. Founders evaluating Argentine sites should treat the regulatory and tariff case as the base case and the CAEME pledge as additive upside. Disposición 7516/25 and Disposición 2978/2026 are in force regardless.

    How to Sequence Argentina in 2026

    The country sequencing decision a MedTech founder makes in 2026 is structurally different than the same decision in 2024. Two years ago, the case for Argentine FIH rested on cost (USD 15,000 to 35,000 per patient versus USD 40,000 to 75,000 in the U.S. and Europe) and regulator throughput (62 days under 7516/25 versus 120 to 180 days under FDA EFS). Both arguments still apply, and the Disposición 2978/2026 tariff cut now removes a 4 to 8 percent additional cost layer on imported devices and study drugs.

    What is new in 2026 is the time pressure. The CAEME pledge does not change the operational case. It changes the urgency of the operational case. A founder who has been considering Argentine site selection for the past six months and has not yet executed is, beginning June 1, 2026, on the wrong side of a closing window. By Q4 2026, the same site relationships will be visibly competitive. By Q2 2027, the top-quartile PI list will be substantively claimed.

    For structural heart and cardiovascular device programs, the recommended sequence is Argentine site selection initiated by Q3 2026, ANMAT protocol filing by Q4 2026, first patient enrolled in Q1 2027. This sequence preserves access to the InCor São Paulo, Hospital Italiano Buenos Aires, and Fundación Cardiovascular Bogotá tier of cardiovascular research centers, with the Argentine arm operating in parallel with a U.S. EFS submission.

    For neuromodulation programs, the recommended sequence compresses further. Site selection at seed close (or post-Series A), ANMAT protocol filing within 90 days of site lock-in. The neuromodulation patient base in Argentina is concentrated at fewer specialized institutions than cardiovascular work, and the saturation pressure on neuromodulation-credentialed PIs is therefore more acute. Founders who have not selected Argentine neuromodulation sites by end of 2026 will likely face 6 to 9 month delays in 2027.

    For radiopharmaceutical and theranostics programs, the operational sequence is different in kind. Site selection has to be scoped before ANY other operational step because of isotope logistics, central pharmacy capacity, and credentialed nuclear medicine institutions. Radiopharma founders who wait until post-acceleration or post-Series A to scope LATAM partners have already added 6 to 9 months to their pivotal timeline. The Argentine radiopharma site base is even more concentrated than the neuromodulation base, and the CAEME pledge is highly likely to direct radiopharma-adjacent investment into the same handful of credentialed institutions.

    What This Means for the Colombia Case

    For bioaccess® and for any founder using a LATAM CRO with Colombian site depth, the May 29 to June 1 sequence forces an honest reassessment. Colombia in 2026 holds the following: established U.S.-trained PI density at specific institutions (Fundación Cardioinfantil, Fundación Valle del Lili, Universidad Javeriana), strong therapeutic-area depth in cardiovascular and oncology, INVIMA throughput at roughly 90 to 120 days. Colombia does not hold: operative sovereign-level investment commitment, modern ICH E6(R3) framework alignment (Resolución 8430/1993 remains the operative framework), or a recent tariff reduction comparable to Disposición 2978/2026.

    The Colombia case for 2026 is no longer “cheaper and faster.” The Colombia case is “specific therapeutic-area depth, U.S.-trained PI networks, and complementarity to an Argentine arm.” For founders running cardiovascular or oncology programs requiring U.S. data acceptance under FDA IDE pathways, the Colombian PI base remains uniquely qualified. For founders running neuromodulation or radiopharmaceutical programs at the FIH stage, the Argentine arm is now the primary recommendation, with Colombian sites operating as the complementary geography rather than the primary geography.

    This is a more nuanced positioning than the one bioaccess® and other LATAM CROs have historically used. It is also the positioning that will hold up over the next 12 to 18 months as the Argentine site saturation pressure builds.

    What Founders Should Do Before End of Q3 2026

    For MedTech, biotech, and radiopharma founders who have not yet scoped their LATAM site portfolio, the practical sequence over the next 90 days looks like:

    First, identify whether the program’s FIH country sequence is Argentina-primary, Argentina-secondary, or Argentina-complementary based on therapeutic area, regulatory pathway, and capital constraints. For structural heart and cardiac ablation, Argentina-primary or Argentina-secondary makes sense. For neuromodulation, Argentina-primary. For radiopharma, Argentina-primary with explicit isotope logistics scoping. For oncology devices with U.S. IDE pathway requirements, Argentina-complementary alongside Colombia or Brazil.

    Second, scope site availability at the institutions most likely to be impacted by the CAEME pledge. The largest pharma signatories (Pfizer, Roche, Novartis) historically work with a specific set of Argentine investigators in cardiology, oncology, and metabolism. Site availability at those investigators will compress first.

    Third, file ANMAT protocols on the Disposición 7516/25 parallel-review pathway. The 62-day timeline allows a 2026 Q3 site selection to produce first-patient-in by year-end. Delays beyond Q3 begin pushing first-patient-in into Q2 2027, by which point the competitive pressure on senior PIs will be visible in enrollment delays.

    Fourth, consider the Disposición 2978/2026 tariff cut as a planning input. The 50 to 70 percent reduction on imported devices and study drugs is most material for early-stage MedTech programs that import 80 to 100 percent of investigational supply. Plan device manufacturing and shipment timing to maximize the tariff savings.

    The Bottom Line

    Argentina did not become a clinical research hub on May 29, 2026. Argentina has been a clinical research hub for 30 years. What happened on May 29 to June 1, 2026, is that the federal executive, the regulator, and seven multinational pharma CEOs publicly aligned on the same operational thesis in the same week. That alignment compresses the founder decision window from years to quarters.

    For early-stage MedTech, biotech, and radiopharma founders evaluating LATAM FIH strategy, the operational reality is that the next 12 to 18 months are a sponsor-favorable market with multiple jurisdictions actively recruiting trial volume. Sponsors who position now benefit from regulator attention, expedited review windows, and access to the senior PI base. Sponsors who delay lose that window.

    The most expensive FIH decision a founder makes is not the per-patient cost of a single study. It is the calendar cost of choosing the wrong country sequence for their specific program. Argentina’s May 29 to June 1 sequence makes the calendar argument harder to ignore.

    If you are evaluating a 2026 LATAM FIH country sequencing decision and want a tailored proposal that incorporates the new ANMAT regulatory and tariff environment alongside Colombian and Brazilian complementary site options, the team at bioaccess® can produce a country-level model within two weeks. We have run FIH trials across Argentina, Colombia, Brazil, and Mexico since 2010, and our U.S. EFS plus LATAM FIH practice is the only one in Latin America structured to deliver both pathways under a single operational team.

    Citations:

  • Law 14.874/2024 Explained: How Brazil’s 90‑Business‑Day Review Window Changes Early‑Stage Clinical Trial Planning

    Law 14.874/2024 Explained: How Brazil’s 90‑Business‑Day Review Window Changes Early‑Stage Clinical Trial Planning

    For MedTech and Biopharma teams considering Latin America, Brazil has historically been seen as a high-potential but hard-to-predict jurisdiction for early-stage clinical trials. That uncertainty can inflate budgets and push teams toward smaller, single-country feasibility strategies.

    Brazil’s Law No. 14.874/2024 introduced a clear constraint: for primary petitions for clinical trials with humans (for marketing authorization purposes), the health analysis may not exceed 90 business days. The law also describes how additional information requests affect the clock.

    This article explains what the 90-business-day window means in practical terms, how sponsors can build a sponsor-ready activation timeline around it, and what pitfalls still cause delays even in a more predictable regime.

    What the law changed (and what it did not)

    The most sponsor-relevant shift is that a defined review window reduces planning ambiguity. A predictable maximum review duration enables better parallelization: ethics preparation, site contracting, and supply chain setup can be scheduled against a more reliable regulatory milestone.

    However, a legal review window does not automatically eliminate operational delays. Sponsors still need to manage:

    • Dossier completeness and consistent technical documentation
    • Ethics sequencing across institutions and committees
    • Import readiness for investigational product shipments
    • Site activation capacity (training, contracting, scheduling)

    In other words, the “clock” helps the regulatory portion of the critical path—but the rest of the program still needs a plan.

    Translating “90 business days” into an activation timeline

    Sponsors often underestimate how different business days can be from calendar days when building a global timeline. A pragmatic approach is to create three layers:

    • Regulatory layer: submission, review window, and potential information request handling
    • Ethics layer: committee submissions and approvals (often overlapping but not identical to regulatory steps)
    • Operations layer: contracts, budget approvals, training, and supply chain readiness

    A sponsor-ready planning template for Brazil should include:

    • Week 0–2: lock document ownership, finalize submission-ready dossier, confirm translation requirements, and run an internal quality check.
    • Week 2–4: submit to the relevant bodies; initiate site contracting and budget cycles in parallel.
    • During review window: implement a weekly “readiness review” covering import documentation, device labeling alignment (if applicable), training scheduling, and monitoring plans.
    • Upon clearance + ethics alignment: initiate first shipment, conduct site initiation, and begin enrollment.

    The objective is to avoid a common failure mode: regulatory clearance arrives, but operations are not ready—so the team loses the predictability advantage that the defined window provides.

    How information requests can still create delays

    Even with a defined maximum window, sponsors should plan for information requests. The practical lesson is to assume that the first submission must be as complete as possible, and that the team must be ready to respond quickly.

    To reduce the chance of delays:

    • Assign a single submission owner responsible for consistency across protocol, investigator brochure (if applicable), device dossier, and administrative documents.
    • Create a rapid-response package before submission: technical specs, risk management summaries, labeling variants, and manufacturing documentation.
    • Pre-brief sites on likely follow-up questions so responses do not stall waiting for institutional input.

    Speed matters because information requests often pause progress until the sponsor responds, and slow responses can negate the benefits of the defined review period.

    Why Brazil’s predictability matters for LATAM multi-country strategy

    For some early-stage teams, Brazil may now be easier to include in a multi-country Latin America strategy when paired with other jurisdictions. The strategic value is not only speed—it is credibility of planning. When leadership teams can explain why the timeline is realistic, financing, vendor contracting, and site commitments become easier.

    To maximize the benefit, sponsors should treat Brazil as one component of a LATAM activation architecture:

    • Define a country sequencing strategy (which country starts first and why)
    • Standardize document templates across countries (with country annexes)
    • Build a supply chain plan that can support staggered activations without stockouts

    When done well, the result is not just a faster first patient in; it is a trial program that is easier to scale.

    FAQ

    Does the 90-business-day window guarantee approval?

    No. A defined window is about timing, not outcome. Sponsors still need a complete, well-justified dossier and an operational plan that supports ethics and site readiness.

    Should early-stage sponsors wait for Brazil before activating other LATAM countries?

    Not necessarily. Many sponsors can run activities in parallel across countries. The right choice depends on device complexity, supply chain constraints, and how quickly the sponsor can support multiple site activations.

    What is the single biggest mistake sponsors make with “faster” regulatory timelines?

    Assuming that regulatory speed automatically creates operational speed. The winning approach is to use predictability to parallelize work—contracts, training, and import readiness—so the program is ready when clearance arrives.

    Bottom line: Brazil’s Law 14.874/2024 gives sponsors a more predictable planning horizon. The teams that benefit most will be the ones that treat the regulatory window as a scheduling tool—and execute the operational readiness plan in parallel.