The Federal Commission for Protection of Sanitary Risks (COFEPRIS) is in charge of registering any healthcare product. The regulatory system consists of mandatory standards known as NOMs and voluntary standards known as NMXs. Medical devices are classified according to a catalogue that consists of three areas; instrumental, medical equipment and material for prosthesis and or thesis.
 
To be able to market a product in Mexico the manufacturer must have an office or a distributor in Mexico. The local representative is responsible for the registration and must submit all required product information to the authority. A new law passed enables devices that have been approved by the USFDA or Health Canada to only have to submit a Certificate to Foreign Government (CFG) or HC license of their products. Those applications are reviewed and approved in 30 day unless something significant is found, which should normally not be the case. For HC license there are a couple of additional forms in the application that are required. Our country specific (*) regulatory services in Mexico include:
 
Medical Device specific regulation strategy reports, Medical Device Registration with COFEPRIS, COFEPRIS Technical documents Preparation, Mexico license holder and local Authorize Representative and Arazy Group’s unique line of GlobaR - Global Regulatory Hub™ products.

GlobaR Dossier™
GlobaR - One World Process™
GlobaR Submission Center ™
Universal Authorized Representative™
 
Please fill the following form, submit your inquiry or discuss it with one of our online specialists. Let's get your products registered in Mexico!

(*) Mexican Regulatory Affairs services are part of the diverse professional consulting services provided by Arazy Group and can be found thorough this web site and inquired on through our form or online chat services.