This episode of LATAM MedTech Insights offers a detailed guide to registering your medical device in Colombia, focusing on the foundational regulation, Decree 4725 of 2005. We break down the essential requirements set by Colombia's regulatory authority, INVIMA, providing manufacturers with a clear roadmap for successful market entry into one of Latin America's most dynamic healthcare markets. Imagine your company has developed an innovative Class IIb diagnostic device. You are ready to tap into the Colombian market, but your submission is rejected by INVIMA. The reason is a failure to properly appoint a local legal representative and your Instructions for Use (IFU) were not translated into Spanish according to specific regulatory standards. This single oversight delays your launch by over six months, allowing competitors to establish their footprint. This episode provides the details to avoid such costly mistakes. Key Takeaways: 1. What are the four distinct risk classifications for medical devices under Decree 4725 of 2005? 2. Does your product qualify for the faster "automatic registration" pathway in Colombia? 3. Why is a Certificate of Free Sale (CFS) from your device's country of origin an absolute must-have for your INVIMA submission? 4. What are the legal responsibilities of the mandatory in-country representative in Colombia? 5. What are the specific Spanish-language labeling requirements that can lead to an application's rejection? 6. How long is a medical device registration valid in Colombia, and what should you know about the renewal process? 7. What key technical documents are required by INVIMA for a Class IIb or Class III device submission? At Pure Global, we specialize in navigating these complex regulatory landscapes. We offer end-to-end solutions, from market strategy and local representation to AI-powered technical dossier preparation, ensuring your path to the Colombian market is efficient and successful. For expert guidance, contact us at [email protected] or visit us at https://pureglobal.com/.