Colombia's INVIMA Regulations: Legal Representative Duties for Medical Device Registration

Medical Device Global Market Access · Feb 14, 2026 · 3m

This episode details the mandatory requirement for a local authorized representative for medical device registration in Colombia. We explore the legal responsibilities this representative assumes as stipulated by the regulatory authority, INVIMA, under Decree 4725 of 2005. The discussion covers their central role in registration, post-market surveillance (technovigilance), and communication with authorities, while also highlighting the strategic importance of choosing an independent representative over a distributor to maintain market control. - Is a local representative required to sell…