Latest / Medical Device Global Market Access
Colombian Market Entry: Your Guide to Decree 4725 and INVIMA
This episode provides a comprehensive guide to Colombia's medical device regulations, focusing on the foundational Decree 4725 of 2005 and the role of the regulatory body, INVIMA. We explore the four-tiered risk classification system, the detailed registration process for different device classes, the critical requirement of appointing a local representative, and the importance of post-market surveillance through the Tecnovigilancia program. Key Questions: • What is the foundational law for medical devices in Colombia and which agency enforces it? • How does Colombia's risk classification…
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