cms.bioaccessla.com

Clinical trial execution in Colombia: why we recommend it now

Written by

Julio Martinez-Clark

in

,

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

More posts