COFEPRIS Uncovered: Comparing Mexico's Device Classification to FDA and EU Rules

Medical Device Global Market Access · Jan 24, 2026 · 3m

This episode provides a detailed overview of Mexico's three-tiered medical device classification system managed by COFEPRIS. We explore how Class I, Class II, and Class III devices are defined by risk and highlight the key differences between Mexico's framework and the systems used by the US FDA and the European Union. Understanding these nuances is the critical first step for successful market entry. - How does Mexico's COFEPRIS classify medical devices? - What are the three risk-based classes for medical devices in Mexico? - Is there a special category for low-risk Class I devices in…