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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 medical device oversight. Emergo Mexico is an experienced, independent medical device Registration Holder and consulting firm with offices in Mexico City.
Why select Emergo Group 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 or add distributors because the new distributor would need permission from the existing distributor to import your devices or they 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, 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
- Ongoing service for clients is provided by our Austin, Texas office in close cooperation with the office in Mexico City
- Issuance of registration certificates by COFEPRIS in name of a distributor may limit your control over the device registration. The MRH is viewed by COFEPRIS as the “master distributor/registration holder” and owns the registration, including dictating if other distributors are allowed to import under the approval in their name and allowing the transfer of your registration. If you select Emergo as the MRH, Emergo will be identified on the registration certificate and would fully cooperate with you so that you control the approval of your device on the market.
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.
Commonly Asked Questions:
How do I control my approval with Emergo Group as my Mexico Registration Holder?
COFEPRIS allows for the registration holder to add multiple distributors into the registration. Emergo Group will submit the registration as the primary holder/controller and will then add your other distributors into the registration, giving them “permission” to commercialize your products, but not to have any control or access to information. You can include several distributors in that initial registration and if you would like to add a new distributor later, we can modify the registration to include them. Once approved, those distributors can begin importing directly and Emergo Group does not have to be involved in an ongoing basis. In this way you can maintain control over your approval and your commercial relationship with your distributors will be direct.
Can I transfer my registration to another local registration holder?
Registrations can be transferred in Mexico as long as the original holder will agree, providing a signed, notarized letter stating that they will give up the registration, along with a copy of the Registration Certificate plus any modifications made after the approval. In Emergo Group’s experience, most registration transfers are not successful as it is very difficult to obtain both of these documents from the original holder, and companies often end up having to submit a new application to COFEPRIS.