Go-to-market strategy
Mexico is a medical device market with explosive growth, and the possibilities are almost endless for device manufacturers, especially for those who have already obtained registration in Japan, the USA, and Canada.
COFEPRIS slowly aligns the regulation to EU regulation which opens opportunities for CE-marked devices to enter the market faster.
Free introductory call
Mexico vs EU/US Medical Device Regulations
- Appoint of Mexico Registration Holder
- Labelling must be in Spanish
- Import permits required for Class III implantable devices
- All documents included in the registration dossier shall be translated into Spanish
- Although, translation to Spanish is no longer mandatory for technical documents that are provided in English (e.g., for class III implantable devices).
Qserve services for Mexico
- Global Regulatory Strategy
- Registration support in Mexico
- Cofepris certification
- Review process technical documentation
- QMS ISO 13485 support
- Translation label and IFUs based on requirements
- Conformity Assessment route support
Services
Representation for foreign manufacturers
Mexican Registration Holder (MRH)
Foreign manufacturers require a local Authorised Representative, also known as a Mexico Registration Holder (MRH), to interact on their behalf with COFEPRIS and own the registration. The Mexican Registration Holder (MRH) must also be a Mexican legal entity.
Main responsibilities of the holder:
- To be the main point of contact in Mexico with COFEPRIS.
- Apply for any process with COFEPRIS related to the registrations or any product.
- Report any incidence in terms of Technovigilance
Benefits of having a holder as a commercial partner:
- Assign or remove local distributors, avoiding dependence on them.
- Have a localally, with a local presence to oversee your sanitary authorizations.
Standard (class I)/Standard+Third-Party Review process
Time:
Generally, 12 months or in case of Third Party Reviewer: around 3 to 6 months upon submission.
Third-Party Reviewer:
$2,000-4,000 USD depending on the reviewer and the device class.
COFEPRIS fee: $500-1,100USD depending the device class.
Equivalency agreement (class II and III)
The equivalence route is applicable for products approved by US FDA, Health Canada (only for Class II-IV) and Japan (only for Class II-IV). For these types of devices, there is an expedited review process, allowing for faster review and approval.
- Time: 8-11 months for FDA and HC approved products and 5-8 months for Japan (Equivalence Agreement of 2012).
- The option for Third Party Reviewers is not applicable for this route.
- COFEPRIS fee: $500-1,100 USD depending the device class.
If your product only has European CE Marking or other national approval, it is possible to leverage information from your existing Technical File or registration dossier to prepare your submission to COFEPRIS.
Contact us to see to what extent your existing documentation can be suitable for achieving regulatory compliance in Mexico
Important links and guidance