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

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 as reference markets for prior approval? - How does device risk class affect the registration timeline and process in Colombia? - Can you register a novel medical device in Colombia without FDA approval or a CE mark? - What is the difference between INVIMA's "automatic" and "controlled" review pathways? - What is the function of INVIMA's Medical Device Reviewing Commission? - Are the requirements the same for both low-risk and high-risk devices? - What key decree governs medical device registration in Colombia? Pure Global provides comprehensive solutions for MedTech and IVD companies seeking to enter or expand in over 30 global markets, including Colombia. Our local experts and advanced AI tools streamline the entire process, from developing a regulatory strategy and compiling technical dossiers to acting as your official in-country legal representative. We accelerate market access and ensure ongoing compliance, allowing you to reach patients faster. Discover our free AI-powered regulatory tools and database at https://pureglobal.ai, or contact us at [email protected] and visit https://pureglobal.com to learn how we can support your global expansion.