Checklists
Checklist for Medical Devices Registration Renewal Class I – Low Risk Devices
Submission requirements
Notes
Supporting Documents
1. Application Form and Payment of Fees
The payment is performed by the Mexican Registration Holder (MRH). 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. Simple copy of the Sanitary Registration
The most updated version. For any pending sanitary registration response in COFEPRIS provide the process receipt as well.
4. Power of Attorney
Issued by the MRH giving the legal representative the authority to apply for renewals before COFEPRIS. An original or Certified copy is required.
5. Labels used for products imported and commercialized in Mexico
Labels currently in use should meet the requirements of the Mexican Labeling Norm NOM-137-SSA1-2008, as devices have already been on the market for five years. Examples of the physical labels stuck/printed on the packages work very well.
6. Instruction for use, Package Insert, Operation Manual, as applicable (in Spanish)
Must match the last IFU submitted to obtain the COFEPRIS Registration.