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.