Mexico's COFEPRIS Approval: Fast-Tracking Cardiology & Radiology Devices

Medical Device Global Market Access · Dec 24, 2025 · 3m

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…