Episode Details

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 system for medical devices compare to the EU's? • Is a local representative in Colombia required to register a medical device? • Can approval in the EU or US help speed up registration with INVIMA? • For how long is a medical device registration valid in Colombia? • Who should be the legal owner of the registration – the manufacturer or the distributor? • What are the post-market surveillance requirements, known as Tecnovigilancia? • In what language must all registration documents be submitted to INVIMA? • Have there been any recent updates to the original 2005 decree? Ready to turn these insights into your competitive edge? Pure Global’s regulatory experts guide MedTech companies through every step of 30+ markets worldwide. Explore how we can accelerate your market entry at https://pureglobal.com or email info@pureglobal.com for tailored support.