GRP Mexico can help you obtain COFEPRIS medical device registration and approval to sell your product on the Mexican market.
GRP in Mexico helps your company obtain medical device registration in Mexico. If your company does not have an office in Mexico, you must designate the owner of the registration as the representative of your country. The registrar is responsible for the coordination, submission, and management of the registration of medical devices in COFEPRIS, the Department of Control of Medical Devices of the Mexican Ministry of Health. MRH also checks your registration and should be chosen very carefully.
Importance of Independent COFEPRIS Registration in Mexico:
Medical device companies entering the Mexican market rely on distributors who coordinate the registration and approval of their devices and act as registration holders. Although this seems convenient, changing or adding distributors can be very difficult because your distributor is now actually the owner of your registration.
For a possible change of distributor, the new distributor will need permission from the current distributor (your registrar) to import the equipment. If the previous distributor does not cooperate, you will need to re-register the device if you want to appoint a different registrant.
Clarifications for Medical Device Registration Holders in Mexico:
- COFEPRIS allows the registry holder to add multiple distributors to the registry.
- GRP Mexico will submit the registration as the primary holder/controller and will add your distributors to the registration allowing them to market your products, but without control or access to your confidential information.
- You can include as many distributors as you like in your initial registration. GRP MX can make the necessary changes to the registration to include new distributors at any time.
- Approved distributors can import directly without the ongoing involvement of Global Regulatory Partners, so the holder can maintain control of their approval and maintain a direct business relationship with their distributors.
- Local registration holders can be transferred in Mexico, provided that the original holder agrees and signs a transfer of rights contract with the new holder, before a notary, stating that they will give up the registration, along with a copy of the Registration Certificate and any modifications made after approval.
- The previous registration holder must also provide a complete copy of the technical dossier sent to COFEPRIS.
Time GRP México Services
- GRP Brazil acts as the official regulatory representative in the country.
- We can fully assist in obtaining Mexican approval for medical devices from COFEPRIS.
- Our experienced consultants are dedicated to the medical device sector.
- GRP BR will cooperate fully with you so that you have complete control of device approval.
- Our expertise and local presence will support you and help you succeed in Mexico.
Medical Device Future in Mexico
Global Regulatory Partners Mexico believes that this guidance is intended to align COFEPRIS reviewers and set user expectations. In addition, it seems that truly administrative modifications are intended to be reviewed more quickly. Minor and moderate modifications to the registrations of allopathic, herbal and homeopathic medicines will be approved immediately as of August 28, 2023, so we hope that this represents a step towards immediate approvals for administrative modifications of medical products in the near future, too.
Learn more about Cofepris
We are a global consulting firm Headquartered in Boston Massachusetts USA that provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical and medical device companies worldwide to register their products with the Mexico's Cofepris the local Health Authority (HA)
We are a global consulting firm Headquartered in Boston Massachusetts USA that provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical and medical device companies worldwide to register their product with the Food and Drug Administration (FDA) the local Health Authority (HA)
About Global Regulatory Partners Group
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.