Mexico medical device market 101

Our Emerging market series continues! In previous Emerging markets articles, we looked in detail at some of the largest medical device markets, specifically Asia Pacific, Middle East, and Latin America and further analysed a selection of the markets in each region.

Now, we are looking into those territories once again to offer a more succinct look at some of the other potential access markets in those regions.

While it may not typically appear on a list of leading emerging markets in recent years, Mexico is the second largest medical device market and leading importer in the Latin America region.

Medical devices imported or distributed within Mexico must first be registered with the Ministry of Health (COFEPRIS). Medical devices are grouped according to their purpose such as dental supplies, medical equipment, surgical and Software (SaMD), which was just recently added. There are four risk classes (Low risk class and Class I to III). The classification of your device should be determined according to the Ministry of Health’s classification rules within the Mexican Pharmacopoeia.?

Foreign Manufacturers with no legal office in Mexico will need to appoint a Mexico Registration Holder to serve as your in-country authorised representative and manage your device registration process with COFEPRIS.

Read more on the two main regulatory pathways to enter the medical device market in Mexico in the final instalment of our second series dedicated to emerging markets: https://imedconsultancy.com/mexico-medical-device-market-101/