This episode explores the lucrative Mexican market for interventional cardiology and radiology devices, detailing the COFEPRIS registration process. We cover the mandatory appointment of a Mexico Registration Holder (MRH), device classification, and the critical differences between the standard and expedited Equivalency Pathways. Learn how leveraging prior approvals from the US, Canada, or Japan can fast-track your market entry and what key regulatory changes are coming in 2025.

- What is COFEPRIS and what is its role in Mexico?

- Why is a Mexico Registration Holder (MRH) essential for foreign manufacturers?

- How does Mexico classify medical devices based on risk?

- What is the Equivalency Pathway and how can it speed up registration?

- Can my existing FDA or Health Canada approval help me enter the Mexican market?

- What are the documentation and language requirements for a COFEPRIS submission?

- What significant regulatory update is happening on September 1, 2025?

- How long is a medical device registration valid in Mexico?

Pure Global offers end-to-end regulatory consulting for MedTech and IVD companies, acting as your local representative in over 30 markets, including Mexico. We develop efficient pathways for COFEPRIS approval by leveraging your existing registrations and using advanced AI to compile and submit your technical dossier. Our team of local experts provides continuous regulatory monitoring to ensure your market presence is maintained. To learn how we can help your company access the global market faster, visit us at https://pureglobal.com/, contact [email protected], or explore our FREE AI tools and database at https://pureglobal.ai.