Latest / Medical Device Global Market Access
COFEPRIS & MFDS: A New 30-Day Fast-Track for Korean MedTech in Mexico
This episode explores the transformative Abbreviated Regulatory Pathway being launched by Mexico's COFEPRIS in September 2025. We detail how this new 30-day process specifically benefits Korean medical device manufacturers holding MFDS approval, outlining the immense opportunity for accelerated market entry. The discussion also covers critical challenges, such as proving product equivalency and navigating submission requirements, to help companies leverage this shortcut effectively. - What is Mexico's new Abbreviated Regulatory Pathway for medical devices? - When does the new COFEPRIS 30-day…
The skinny
The skinny isn't ready yet — notes appear once the transcript is processed.