Dec 10, 2010

Medical devices and IVD products able to pass muster with the US FDA and Health Canada may now enjoy de facto access to Mexico as well thanks to recent regulatory reforms. The Mexican Health Authority’s Federal Commission for Protection against Sanitary Risks (COFEPRIS) has put into effect new rules recognizing medical device authorizations for Class I, II and III commercialized products in the US, as well as for Class II, III and IV commercialized products in Canada. A new eJournal article from Emergo Group explains the specifics of the new rule that COFEPRIS has made available, but many details remain forthcoming. Suffice it to say that going forward, it appears as though medical device and IVD manufacturers already authorized to sell their products in the US or Canada will enjoy a two-for-one (or three-for-two) deal when it comes to achieving regulatory approval in all three major North American markets. Bottom line: Depending on the classification of their products, medical device and IVD manufacturers already authorized by either the FDA or Health Canada can extend their marketing to Mexico without any significant new regulatory hurdles.


  • Stewart Eisenhart