Colombia's INVIMA Registration: Is FDA or CE Mark Approval a Must?

Medical Device Global Market Access · Feb 17, 2026 · 3m

This episode explores the requirements for medical device registration in Colombia, focusing on whether prior approval from a reference country like the US or EU is mandatory. We detail the role of a Certificate of Free Sale (CFS), the different regulatory pathways defined by INVIMA based on device risk classification (Class I, IIa, IIb, III), and the specific process available for novel devices that have not yet received marketing authorization in any country. - Is a Certificate of Free Sale (CFS) mandatory for medical device registration in Colombia? - Which countries does INVIMA recognize…