Medical Device Regulatory Overview (Mexico)
Considering Mexico as the second largest medical device market in Latin America, you may find it as a good alternative to expand your business. Nevertheless,
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Considering Mexico as the second largest medical device market in Latin America, you may find it as a good alternative to expand your business. Nevertheless,
In accordance with Mexican laws, importing a medical device in Mexico requires a valid Import Permit, this document is issued by COFEPRIS. There are
A third party reviewer (TPR) is a company authorized by COFEPRIS to review and issue an opinion regarding the compliance of a medical device
Last March the 6th, COFEPRIS updated its Good Manufacturing Practices (GMP) guide. This guide describes the criteria to evaluate the good manufacturing practices certificates
Every controlled medical devices intended to be sold in Mexico must undergo a previous authorization by the Mexican Ministry of Health before its commercialization.