Sponsors keep asking how to get IRB approval for a medical device study in Colombia as if ethics were a single stamp that also clears INVIMA. It is not. In Colombia the ethics desk is a Comité de Ética en Investigación (CEI) approved by INVIMA, sitting at an IPS that holds a current Buenas Prácticas Clínicas (BPC) certificate. The investigation opinion and the import authorization are separate desks. Mixing them is how first patient slips a cycle.
I am Julio Martinez-Clark, CEO of bioaccess®. This is the Colombia ethics walkthrough for medical-device studies, grounded in the live Colombia clinical-trial execution pillar, the INVIMA clinical-trial submission checklist, and the universal LATAM FIH submission package. It is not a quote and not legal advice. Confirm every form against INVIMA’s current Investigación Clínica — Dispositivos page before you file.
What “IRB” means in Colombia
US sponsors say IRB. In Colombia the working term is CEI — an INVIMA-approved research ethics committee. The CEI reviews the protocol, informed consent, and investigator packet under the human-subjects rules in Resolución 8430 de 1993. The CEI letter is not an INVIMA investigation opinion, and it is not a Registro Sanitario.
Write three owners before you open a Spanish translation folder:
- CEI / ethics. INVIMA-approved committee; initial study evaluation on form ASS-RSA-FM169.
- INVIMA investigation opinion. For devices, the Sala Especializada de Dispositivos Médicos y Reactivos de Diagnóstico In Vitro (SEDMRDIV), supported since 20 September 2022 by the GICASE group under Resolución 2022035262. Forms ASS-RSA-FM085 / ASS-RSA-FM172.
- Import of the investigational article. Exceptional importation under Decreto 4725 de 2005 Article 48(b), against a prior specialized-chamber opinion — not a commercial registro number on the airway bill.
If your Gantt has one bar labeled “Colombia IRB,” you do not have an ethics plan. You have a hope.
Site prerequisites the CEI will not waive
A Colombian interventional device study needs more than a friendly PI:
- A CEI approved by INVIMA.
- A site (IPS) with a current BPC certificate. INVIMA issues that certificate after verifying compliance with Resolución 2378 de 2008 through inspection visits. The certificate runs five years.
- Evidence that the institution is registered under the Sistema Único de Habilitación with authorized pharmaceutical service, clinical laboratory, and sample-collection services inside the same habilitación. Contracting those services outside the habilitación adds documentation to every BPC modification.
INVIMA’s register of approved research ethics committees places them in Bogotá, Medellín, Cali, Floridablanca, and Montería, attached to established IPS and medical foundations. Bogotá, Medellín, and Cali remain the tier-1 clusters for most device programs. Replacing a site’s ethics committee is a formal BPC modification: a new-conditions verification visit and a written transfer plan agreed with sponsor, CRO, and both committees. Treat CEI selection as a critical-path item, not an afterthought.
Step-by-step: ethics before (or beside) the INVIMA file
Colombia is not Panama’s parallel Type II + MINSA corridor. Plan CEI, INVIMA concept, and import as sequential critical-path items unless your operator has a documented reason to overlap them. The measured INVIMA average footed on the Colombia execution pillar is 5.1 months to a definitive concept (approve or reject). There is no statutory day-count for that concept. Do not paste a fast-corridor ethics band onto Bogotá.
- Freeze the protocol version that every desk will see. The universal FIH core already names protocol, investigator’s brochure, informed consent, case report form, insurance, and preclinical testing. Colombia’s country add-on is a procedure-risk matrix — procedural risk, not FDA-style design verification.
- Pick the IPS and confirm BPC + CEI status on INVIMA’s published registers before contracting. Do not discover a lapsed BPC certificate after the consent is translated.
- Draft Colombian informed consent for that CEI — regulatory Spanish adapted for the committee, not a U.S. IRB form with a machine translation stapled on.
- File the CEI package with ASS-RSA-FM169 (initial study evaluation completed by the ethics committee) and the reconciled Spanish + English pack: protocol, IB/preclinical, risk management (ISO 14971) appropriate to class, IFU and investigator training, clinical-trial insurance covering Colombian subjects, investigator CVs and GCP certificates, site budgets and contracts running in parallel so activation is not the bottleneck after the opinion lands.
- Keep the CEI letter and the SEDMRDIV file on the same investigation story. Stopping rules, device description, and the article you will import must match. Prototype authorization under Decreto 4725 de 2005 Article 36 is research and experimentation only — not health care use, not a commercial registro number.
- Only then treat import as its own authorization under Article 48(b). The CEI stamp does not clear customs.
What the CEI packet must prove
| Packet item | What it proves | Common stall |
|---|---|---|
| Protocol + stopping rules | Same investigation the SEDMRDIV will see | Version drift vs the INVIMA file |
| IB / preclinical | Risk profile for first human use | Thin bench package, hoping ethics will “fill gaps” |
| Colombian ICF | Subjects informed in local regulatory language | US IRB text with Spanish overlay |
| Insurance | Coverage for Colombian subjects | Policy that does not name the territory or runoff the CEI expects |
| Investigator docs | Qualified team at a BPC site | PI CV without current GCP evidence |
| Procedure-risk matrix | Colombia add-on on procedural risk | Treating it as a product design-verification dump |
Timelines you can put on a board slide
- CEI cadence — committee-specific. Confirm meeting frequency during site selection. This page does not invent a national CEI day-count.
- INVIMA concept — measured average 5.1 months to a definitive concept; no statutory clock. Published approval and non-approval registers exist for device studies — read the non-approval register before you invent a “Colombia is unpredictable” narrative.
- Import — after the specialized-chamber path that Article 48(b) requires. Plan it as its own bar.
- Not law yet — the clinical-research framework bill filed in the Cámara in August 2025 would introduce tacit approval (7 calendar days common-risk / 30 high-risk, with FIH and novel implantables as high-risk). Do not put that clock in a diligence deck as if it were current INVIMA practice.
Common mistakes that burn ethics weeks
- Treating CEI approval as if it were the INVIMA investigation opinion or Registro Sanitario.
- Skipping BPC / habilitación checks, then losing weeks on a BPC modification mid-startup.
- Filing a drug Protocolos en Línea path (tariffs 4070 / 4083) for a device SEDMRDIV file — wrong desk.
- Assuming post-trial access is mandatory in Colombia. It is not. Resolución 2378 de 2008 and Resolución 8430 de 1993 contain no statutory post-trial supply duty; see the LATAM PTA operator map.
- One workstream for FIH evidence and later commercial registro. Article 18(k) of Decreto 4725 de 2005 is why class IIb and III evidence and registration strategy belong in the same plan — not why they share one ethics form.
Related reading on bioaccessla.com
- Clinical trial execution in Colombia
- INVIMA clinical-trial submission checklist
- How to run a first-in-human medical device trial in Colombia
- Ethics committees in Latin America: parallel vs sequential
- Universal LATAM FIH submission package
- CRO in Colombia · Colombia regulatory guide
Planning CEI plus INVIMA sequencing for a device study in Bogotá, Medellín, or Cali? bioaccess® is a US-headquartered, LATAM-native operator running regulatory submissions, importadora functions, and 2–8 °C GDP cold chain across the region. Contact Julio Martinez-Clark, Co-Founder & CEO, at jmclark@bioaccessla.com or +1 (954) 903-7210. More at bioaccessla.com/roadmap.
Frequently asked questions
How do I get IRB approval for a medical device study in Colombia?
Engage an INVIMA-approved CEI at an IPS with a current BPC certificate, file the ethics package (including ASS-RSA-FM169), and keep that packet aligned with the separate SEDMRDIV investigation file and Article 48(b) import path. The CEI letter alone does not authorize the study or the investigational shipment.
Is Colombia’s CEI the same as INVIMA authorization?
No. Ethics (CEI), INVIMA investigation opinion (SEDMRDIV / GICASE), and exceptional import are three desks under Decreto 4725 de 2005, Resolución 8430 de 1993, and the BPC regime in Resolución 2378 de 2008.
Which cities have INVIMA-approved ethics committees?
INVIMA’s published register places approved committees in Bogotá, Medellín, Cali, Floridablanca, and Montería. Tier-1 device work usually concentrates in Bogotá, Medellín, and Cali.
How long does Colombia ethics plus INVIMA take?
CEI timing is committee-specific. INVIMA’s measured average to a definitive concept is 5.1 months with no statutory day-count. Plan sequential desks unless you have a documented overlap plan.
Does every Colombian site need a BPC certificate?
Yes in practice for institutions running interventional research under INVIMA oversight. The certificate runs five years and depends on habilitación services inside the same institution.