ANSWERED ON THIS PAGE:
- What is the in-country representation requirement in Mexico?
- What is the role of the Mexico Registration Holder (MRH)?
- Can we select our distributor in Mexico as our representative?
Achieving product registration in Mexico
If your company does not have a location in Mexico, you must appoint a Registration Holder as your in-country representative. 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. Your MRH also controls your registration and should be chosen very carefully.
Why you need an independent COFEPRIS registration holder
Some medical device companies entering the Mexican market rely on distributors to coordinate the registration and approval of their devices and act as their Registration Holder. While this seems convenient, changing or adding distributors can be very difficult because your distributor now effectively owns your registration.
If you were to change distributors, the new distributor would need permission from the existing distributor (your Registration Holder) to import your devices. If your previous distributor is uncooperative, you must register the device again if you wish to appoint a different Registration Holder.
Emergo by UL is an experienced, independent medical device registration holder with offices in Mexico City
Emergo is an independent consulting firm, highly experienced in medical device regulatory issues in Mexico. When you work with us, you can appoint or change licensed distributors at any time, increasing your chances of success in Mexico. Here are a few good reasons to choose us:
- Emergo by UL acts as the official in-country regulatory representative for more than 2,000 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 Mexico City office.
- Emergo will fully cooperate with you so you have complete control of the device approval.
Our expertise and local presence position us to help you succeed in Mexico.
Common questions regarding the appointment of a Mexico registration holder for medical devices
How do I control my approval with Emergo as my Mexico registration holder?
COFEPRIS allows the registration holder to add multiple distributors into the registration. Emergo will submit the registration as the primary holder/controller, and add your distributors into the registration. This approach allows them to commercialize your products, but without control or access to your confidential information. You can include as many distributors in your initial registration as you like. Emergo can modify the registration to include new distributors at any time.
Once approved, those distributors can import directly without Emergo's ongoing involvement. In this way you can maintain control of your approval and maintain a direct commercial relationship with your distributors.
Can I transfer my registration to another local registration holder?
Registrations can be transferred in Mexico as long as the original holder agrees and signs a rights transfer contract with the new holder, before a notary, stating they will give up the registration, along with a copy of the Registration Certificate and any modifications made after the approval. The previous registration holder should also provide a full copy of the technical dossier submitted to COFEPRIS. In our experience, most registration transfers are not successful as it is very difficult to obtain all of the required documentation from the original holder. Companies often end up submitting a new application to COFEPRIS.