Medically reviewed by Dr. Pedro Martinez-Clark, MD and Dr. William O'Neill, MD. Last reviewed: July 2026.
bioaccess® has run first-in-human medical device studies in Colombia since 2010. Because INVIMA clinical-trial approval timelines have become unpredictable, we do not currently recommend Colombia for new first-in-human trial execution. Colombia remains central to our INVIMA commercial market-access work, and we help sponsors select a currently recommended jurisdiction for new studies.
Colombia's regulatory authority, INVIMA (Instituto Nacional de Vigilancia de Medicamentos y Alimentos), holds PAHO/WHO Level 4 status — the highest designation in Latin America — which historically made device approvals credible with the FDA and EMA. bioaccess® built its earliest first-in-human capability in Colombia and completed 30+ device studies there across structural heart, vascular, neurotechnology, orthopedics, ophthalmology, and gene therapy.
Today, however, INVIMA clinical-trial approval timelines have become unpredictable. Because a first-in-human program depends on a reliable start date, bioaccess® does not currently recommend Colombia for new trial execution. We help sponsors choose among the jurisdictions we operate in across Latin America and the Caribbean, matching the country to the device, target FDA pathway, and timeline.
Colombia remains a core market for bioaccess® in a different capacity: INVIMA commercial medical-device registration and market access. If your goal is to register and commercialize a device in Colombia — rather than run a new clinical trial there — INVIMA registration is a service we actively deliver.
bioaccess® supports INVIMA sanitary registration (Registro Sanitario) for medical devices intended for the Colombian commercial market, including device classification, dossier preparation, local legal representation, and post-market obligations. This commercial registration work is distinct from clinical-trial permitting and remains a core bioaccess® service in Colombia.
For clinical investigations, INVIMA issues a Clinical Trial Permit (Permiso Ético y Científico). While bioaccess® historically achieved fast concurrent ethics and INVIMA review, approval timelines have since become difficult to forecast. Because a first-in-human study needs a dependable start date, bioaccess® currently steers new trial execution toward more predictable jurisdictions.
bioaccess® operates at pre-qualified sites across 19 Latin American and Caribbean countries, including Mexico (COFEPRIS), Brazil (ANVISA), Argentina (ANMAT), Panama, Chile, and the Dominican Republic. We recommend the country that best matches your device, target FDA pathway, evidence needs, and timeline.
Foreign first-in-human data is eligible for FDA submission and review when studies comply with ISO 14155 guidelines under proper ethics-committee and regulatory oversight. bioaccess® designs every study — in whichever jurisdiction it runs — with FDA submission in mind, including electronic data capture, structured adverse-event reporting, and core-lab integration when required. Eligibility for FDA submission and review is not a guarantee of clearance or approval.
| Consideration | New clinical trial | INVIMA commercial registration |
|---|---|---|
| bioaccess® current recommendation | Not recommended — use another jurisdiction | Actively delivered core service |
| Primary reason | Unpredictable INVIMA trial-approval timelines | Established, well-defined registration pathway |
| Regulatory instrument | Clinical Trial Permit (Permiso Ético y Científico) | Sanitary registration (Registro Sanitario) |
| bioaccess® experience | 30+ FIH studies completed historically | Ongoing regulatory and market-access support |
| Where to go next | See recommended jurisdictions | See the INVIMA regulatory guide |
bioaccess® has deep first-in-human history in Colombia, but currently recommends more predictable jurisdictions for new trial execution. INVIMA commercial market access remains a core service.
Not currently. bioaccess® has extensive first-in-human experience in Colombia, but INVIMA clinical-trial approval timelines have become unpredictable. Because a first-in-human program depends on a dependable start date, we do not recommend Colombia for new trial execution and instead help sponsors select a more predictable jurisdiction among the 19 countries we operate in.
Yes. INVIMA commercial medical-device registration (Registro Sanitario) and market access remain core bioaccess® services in Colombia. This is distinct from clinical-trial permitting. If your goal is to register and commercialize a device in Colombia, bioaccess® actively delivers that work.
bioaccess® operates at pre-qualified sites across 19 Latin American and Caribbean countries, including Mexico (COFEPRIS), Brazil (ANVISA), Argentina (ANMAT), Panama, Chile, and the Dominican Republic. We recommend the country that best fits your device, target FDA pathway, evidence needs, and timeline rather than a single default destination.
Foreign clinical data is eligible for FDA submission and review under 21 CFR 812.28 when studies are conducted in compliance with ISO 14155 guidelines with proper ethics-committee and regulatory oversight. bioaccess® designs every study with FDA submission in mind. Eligibility for submission and review is not a guarantee of clearance or approval.
bioaccess® has maintained a presence in Colombia since 2010 and completed 30+ first-in-human device studies there across structural heart, vascular, neurotechnology, orthopedics, ophthalmology, and gene therapy, working with ISO 14155 sites in Bogotá, Cali, Medellín, and Barranquilla.
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