As the second-largest country in Latin America, with a population exceeding 125 million and major urban centers in Mexico City, Monterrey, and Guadalajara, Mexico represents a significant market for medical devices, with approximately 80% of devices imported. This import reliance highlights the substantial opportunities for foreign medical device manufacturers seeking Mexico medical device registration.
Vietnam’s Ministry of Health has announced a temporary 50% reduction in government fees for medical device registration and licensing, effective from July 1, 2025, to December 31, 2026. The fee cut applies to new applications for circulation numbers, import/export licenses, testing certificates, and declarations of eligibility, offering cost relief for manufacturers entering or expanding in the Vietnamese market.
From navigating the local regulatory landscape to selecting the right registration pathway, manufacturers registering medical devices with COFEPRIS in Mexico face critical decisions that can impact cost, speed, and compliance. In this video, we’ll walk through the fundamentals of the Mexico device market, how COFEPRIS classifies medical devices, and each step required to register a device for sale from dossier preparation to final approval.
This webinar was hosted by Dr. Oliver Eikenberg and featured our Guest Speaker, Ms. Eva Camatini, Notified Body - IMQ.
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