Checklists
Checklist for Medical Device Registration Renewal – Registrations gotten under equivalency route (FDA or HC) – Applicable to all classes
Submission requirements
Notes
Supporting Documents
1. Application Form and Payment of Fees
The payment is performed by the MRH. The receipt must be included in the final dossier.
2. Warehouses Notice and Health Quality Manager Notice
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. Instructions for use, Package Insert, Operation Manual, as applicable (in Spanish)
Must match the last IFU submitted to obtain the COFEPRIS Registration.
7. Technovigilance Report
Besides the Technovigilance report that covers the last 4 years (for the first renewal) or 5 years (for the subsequent renewals) of operation and any adverse incident, including the response from the CNFV , stating that the submitted report follows the applicable regulation. This report must be maintained by the manufacturer, who will keep it up to date and ensures that the information is complete and accurate.
8. Certificate of Analysis (CoA)
Submit certificates of analysis of recently manufactured devices. It will prove that the devices that are being sold in the country are still meeting the specifications of quality, safety and efficacy. Certificates of Analysis for the raw materials are required in cases where the raw material is in direct contact with the human body. Certificate of Conformance, DHR (Device History Record) test reports are also acceptable to meet this requirement. Your consultant could provide further assistance to prepare this document, if needed.
9. The most recent Establishment Inspection Report (EIR) issued by the FDA to the manufacturing facility or any other, a GMP certificate or The current CAN/CSA-ISO13485:20016 certificate, which incudes CMDCAS
Please also provide legalized copies of the GMPC for all your contract manufacturers. Original or Certified Copy.
10. Representation Letter
Issued by the manufacturer, for any company to act as your Mexican Registration Holder. You will receive the template for the letter from the consultant during the dossier compilation process. Original or Certified Copies are required.
11. Distribution letter
You will receive the template for the letter from the consultant during the dossier compilation process. Original or Certified Copies are required.