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Navigating COFEPRIS: A Guide to Dental Device Registration and Market Access in Mexico
This episode provides a comprehensive guide to the regulatory landscape for dental devices in Mexico. We delve into the role of the national regulatory body, COFEPRIS, and explore the classification system for dental equipment and supplies. The discussion covers the essential requirements for market entry, including the mandatory appointment of a Mexican Registration Holder (MRH), the different registration pathways available—such as the Standard and Equivalency routes—and the critical importance of post-market technovigilance for maintaining compliance. Key Questions: - What is COFEPRIS and…
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