Mexico's IVD Market: Mastering COFEPRIS & Distributor Strategy

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

This episode explores the process of entering Mexico's In-Vitro Diagnostics (IVD) market. We examine the regulatory landscape managed by COFEPRIS, the critical role of a Mexico Registration Holder (MRH), and the strategic implications of choosing a local partner. Using the prominent distributor DIAC as an example, we differentiate between the regulatory and commercial functions essential for success in this major Latin American market. - What is COFEPRIS and how does it regulate IVD devices in Mexico? - Why is a Mexico Registration Holder (MRH) mandatory for foreign manufacturers? - What are…