Mexico
New Cofepris submission guide
Introduction Last 20 February 2020, COFEPRIS issued the Guide for Submissions with the aim of establishing clear rules in the submission process. This document
Mexico
Mexico
Introduction Last 20 February 2020, COFEPRIS issued the Guide for Submissions with the aim of establishing clear rules in the submission process. This document
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 20th 2025, COFEPRIS updated its Guidelines for submitting documents that guarantee Good Manufacturing Practices (GMP). The agreement published in the Official
Every controlled medical devices intended to be sold in Mexico must undergo a previous authorization by the Mexican Ministry of Health before its commercialization.