This episode provides a detailed overview of Colombia's foundational medical device regulation, Decree 4725 of 2005. We explore the critical role of INVIMA, the risk-based classification system, key submission requirements for market approval, and post-market surveillance obligations for MedTech and IVD manufacturers looking to enter the Colombian market.

Key Questions

- What is Decree 4725 and why is it essential for market access in Colombia?

- How does INVIMA classify medical devices based on risk?

- What are the core components of a technical dossier for submission in Colombia?

- Is a local legal representative required to register a medical device in Colombia?

- What are a manufacturer's post-market surveillance responsibilities under Colombian law?

- How does Colombia's regulatory framework compare to others globally?

- What are the first steps to begin the medical device registration process in Colombia?

Pure Global offers end-to-end regulatory consulting solutions for MedTech and IVD companies targeting Latin America. We act as your local representative in Colombia, developing efficient regulatory strategies to navigate INVIMA's requirements under Decree 4725. Our experts and advanced AI tools streamline the compilation and submission of your technical dossier, helping you access the Colombian market faster. Whether you are a startup or a multinational, we ensure your market entry and post-market activities are fully compliant. Contact us at [email protected], visit https://pureglobal.com, or explore our FREE AI tools and database at https://pureglobal.ai.