Pure Global's Guide to Mexico's MedTech Market: The Critical Role of the COFEPRIS Registration Holder (MRH)

Mexico presents a golden opportunity for MedTech companies, but its regulatory body, COFEPRIS, has a critical requirement: all foreign manufacturers must appoint a local Mexico Registration Holder (MRH). This entity doesn't just submit your paperwork; they legally own your product registration, a detail that can make or break your business in the region. This episode of LATAM MedTech Insights dives deep into the strategic importance of this decision. We explore the significant risks of appointing a distributor as your MRH and how this can lead to a loss of market control, and we outline the powerful advantages of partnering with an independent, professional registration holder to secure your investment and ensure long-term business flexibility. Here is a real-world example. A promising diagnostics company spent nearly two years achieving COFEPRIS approval, only to realize their underperforming distributor, who they appointed as their MRH, legally owned their market access. When they tried to switch to a better commercial partner, the distributor refused to transfer the registration, effectively holding their multi-million dollar market entry hostage. Key Questions from this Episode: 1. Who legally owns your MedTech registration in Mexico? 2. What are the hidden risks of appointing your distributor as your COFEPRIS Registration Holder? 3. How can you change commercial partners in Mexico without losing your registration and starting over? 4. What is the difference between a Registration Holder and a local distributor? 5. Why is an independent MRH considered the gold standard for market entry? 6. What clauses must be in your MRH agreement to protect your company? 7. How does the MRH role impact your post-market surveillance obligations? At Pure Global, we specialize in securing your market access. We act as your independent, professional Registration Holder in Mexico and over 30 markets worldwide, ensuring you always remain in control of your valuable registrations. Our end-to-end regulatory solutions, powered by local expertise and advanced AI, are designed to protect your assets and streamline your global expansion. Contact us at [email protected] or visit https://pureglobal.com/ to learn more.