Colombia's INVIMA: Medical Device Registration Pathways and Timelines

Medical Device Global Market Access · Feb 12, 2026 · 2m

This episode provides a comprehensive guide for foreign medical device manufacturers on registering their products in Colombia. We cover the role of the regulatory authority, INVIMA, the risk-based device classification system, and the essential documentation required for a successful submission, including the Certificate of Free Sale (CFS) and ISO 13485 certification. The host details the distinct timelines for low-risk and high-risk devices, explaining the expedited pathway for Class I and IIa products versus the more rigorous review for Class IIb and III devices. - What is INVIMA's role in…