ANSWERED ON THIS PAGE:

• What is the in-country representation requirement in Mexico?
• What is the role of our Mexico Registration Holder (MRH)?
• Can we select our distributor in Mexico as our representative?

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, and controls your registration. It is important to choose your MRH 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 did 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 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 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.