Checklists
Class I – Low Risk
Submission requirements
Notes
Supporting Documents
1. Application Form and Payment of Fees
The mexican registration Holder (MRH) pays. The receipt must be included in the final dossier.
2. Warehouses Notice (Aviso de Funcionamiento) and Health Quality Manager Notice (Aviso de Responsable Sanitario) for the MRH and for all the distributors in Mexico mentioned in the sanitary registration
All Mexican distributors are legally required to have these notices. An electronic copy of the notice(s) is sufficient for the application.
3. Power of Attorney, issuing authority to the legal representative in order to apply for renewals and/or registration submissions to COFEPRIS
An original or certified copy is required.
4. Labels (that will be used for products imported to Mexico) & Label design (Based on the Mexican norm information requirements)
Labels must be in Spanish, and should meet the requirements of the Mexican Labeling Norm NOM-137-SSA1-2008. Whenever Mexican Labels are not yet finalized and compliant, it is necessary to prepare and submit the Label Design.
5. Instructions for use (in Spanish)
The instructions for use can be printed in the label.
6. For any company to act as your Mexican Registration Holder: Original or certified copy of the Representation letter issued by the manufacturer
7. Original or Certified Copy of the Distribution letter for each distributor that you are appointing to the registration