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Accessing Mexico's Dental Market: A Guide to COFEPRIS Regulatory Approval
This episode provides a detailed guide for dental device manufacturers on navigating the regulatory landscape in Mexico. We cover the role of the national authority, COFEPRIS, the critical process of appointing a Mexico Registration Holder (MRH), device classification, and the strategic advantages of using the Equivalency Pathway for faster market approval. We also discuss essential post-market obligations, including Technovigilance and registration renewal. - What is the role of COFEPRIS in regulating dental devices in Mexico? - Why is a Mexico Registration Holder (MRH) essential for foreign…
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