Mexico
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
As mentioned in our Classification and Grouping Ultimate Guide, there is a set of rules to classify and group medical devices in Mexico. Those rules are
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
Content Update & Historical Note: This article reflects the regulatory framework as it stood in June 2021 and is retained for historical context and tracking
Medical electrical equipment (MEE) has their own requirements for safety and performance due to the nature of the electrical/electronic systems involved. In the case
