Navigating Mexico's IVD Market: COFEPRIS Compliance and the Distributor Gateway

Medical Device Global Market Access · Jan 4, 2026 · 3m

This episode explores the strategic necessity for In-Vitro Diagnostic (IVD) manufacturers to partner with specialized, full-service distributors when entering the Mexican market. We discuss the regulatory landscape governed by COFEPRIS, the critical role of the Mexican Registration Holder (MRH), and how an integrated distributor model not only facilitates market entry but also provides essential post-market support, including installation, maintenance, and navigating recent regulatory updates like those from July 2023. Key Questions: - What is COFEPRIS and what is its role in regulating IVD…