Mexico Registration Holder Service for Imported Medical Devices

If your company does not have a sales office or location within Mexico, you will need to appoint a Registration Holder as your in-country representative within Mexico. The registration holder is responsible for coordinating, submitting and maintaining your medical device registration with COFEPRIS, the division within the Mexican Ministry of Health responsible for device oversight. Emergo Mexico is an experienced, independent medical device Registration Holder and consulting firm with offices in Mexico City and Austin, Texas USA.

Why select Emergo Mexico as your COFEPRIS Registration Holder?

Most medical device companies entering the Mexican market have relied upon distributors to coordinate the registration and approval of their devices. While convenient, the problem with having a distributor obtain your device approval is that they control your device registration. This makes it difficult for you to change distributors because the new distributor would need permission from the existing distributor to import your devices or would need to register the device again.

Emergo Mexico is an independent consulting firm, highly experienced in medical device regulatory issues in Mexico. By working with us you will be able to appoint or change distributors at any time, increasing your chances of success in Mexico. Here are a few good reasons to work with us: 

• Emergo Mexico is a division of Emergo Group Inc. which acts as the official in-country regulatory representative for hundreds of medical device and IVD companies worldwide
• We are one of the most respected consultants and Registration Holders for medical device and IVD companies in Mexico
• We can fully assist in obtaining Mexican medical device approval from COFEPRIS
• Our experienced consultants are 100% dedicated to the medical device industry
• We maintain a close working relationship with officials at COFEPRIS and the Secretaria de Salud
• Ongoing service for clients is provided by our Austin, Texas office in close cooperation with the office in Mexico City 

Please contact us for more information or a proposal for having us coordinate approval of your medical device with COFEPRIS and act as your Registration Holder in Mexico.