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 the Colombian medical device market?

- How does Colombia's risk-based classification system work?

- Why is a local legal representative mandatory for foreign manufacturers?

- What is a Certificate of Free Sale (CFS) and why is it essential?

- Do technical documents and labeling need to be in Spanish?

- What are the typical registration timelines for low-risk devices?

- How long does it take to register high-risk devices in Colombia?

- How long is a medical device registration valid for in Colombia?

Pure Global streamlines global market access for MedTech and IVD companies. Our experts act as your local representative in over 30 markets, including Colombia, managing the entire INVIMA registration process. We develop efficient regulatory strategies and use advanced AI to compile and submit your technical dossiers, minimizing delays and ensuring compliance. Let us help you navigate the requirements for the Certificate of Free Sale, quality system documentation, and local regulations to get your product to market faster. Contact us at [email protected], visit https://pureglobal.com/, or explore our FREE AI tools and database at https://pureglobal.ai.