Mexico
Low risk and non-regulated medical devices
Considering the wide range of products within the medical device sector, it is necessary to differentiate them based on their risk level. In Mexico, the
Mexico
Mexico
Considering the wide range of products within the medical device sector, it is necessary to differentiate them based on their risk level. In Mexico, the
Based on our databases, Mexico has more than 2,000 distributors with at least one Sanitary Registration (including Holding companies) and over 100 distributors managing more
In a previous article, we talked about the Good Manufacturing Practices (GMPs) certificates that can be used in Mexico. This certificate is broadly used in
As mentioned in our Classification and Grouping Guide, there are a series of rules to consider when classifying and grouping medical devices. The above-mentioned rules
In a previous article, we explained what a Certificate of Free Sale (CFS) is, and the requirements of COFEPRIS for this document when issued abroad.
Last August 13th 2021, COFEPRIS announced a new version of the so called ECAR program. This is basically an initiative from the authority to minimize