Korean Devices in Mexico: Mastering COFEPRIS Classification and Grouping

Medical Device Global Market Access · Jan 22, 2026 · 2m

This episode focuses on the critical regulatory hurdles Korean medical device companies face when entering the Mexican market. We delve into the specifics of COFEPRIS's three-tier classification system, highlighting its key differences from Korea's four-class MFDS framework. Listeners will learn why misclassification is a primary cause of submission rejections and how a strategic approach to device grouping can significantly reduce registration costs and timelines, ensuring a smoother and more efficient market entry into Mexico. Key Questions: - How does Mexico's COFEPRIS device…