Accessing Mexico's Dental Market: A Guide to COFEPRIS Regulatory Approval

Описание: 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 manufacturers?
How are dental devices classified according to Mexican regulations?
Can existing FDA or CE approvals accelerate the registration process in Mexico?
What is the Equivalency Pathway and how does it work?
Are there specific language requirements for device labeling and documentation?
What is Technovigilance and what are my post-market responsibilities?
How long is a device registration valid in Mexico and how is it renewed?

Pure Global offers end-to-end regulatory solutions to get your medical technology to market faster. Our experts act as your local representative in over 30 markets, including Mexico, managing the entire registration process with COFEPRIS. We develop efficient regulatory strategies, leverage existing approvals to accelerate timelines, and use advanced AI to compile and submit your technical dossier. After approval, we ensure ongoing compliance through continuous monitoring and post-market surveillance. To learn how we can become your trusted partner for market access, contact us at [email protected], visit https://pureglobal.com/, or explore our FREE AI tools at https://pureglobal.ai/.