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Latest / Medical Device Global Market Access

Mexico's Orthopedic Implants Market: Navigating COFEPRIS Regulations & Trauma Sector Growth

This episode explores Mexico's dynamic orthopedic and trauma device market, detailing its significant growth drivers, including medical tourism and an expanding private healthcare sector. We provide a clear overview of the regulatory landscape managed by COFEPRIS, including device classification, the crucial role of a Mexican Registration Holder (MRH), and the equivalency pathway for faster market access. We also highlight the indispensable role of experienced local distributors, using the 40-year history of OHISA as a case study in providing essential products and in-OR technical support. -…

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