Checklists
Class I, II, III – Equivalency route (products approved in the USA, Canada or Japan)
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. Distributor list in Mexico, if known at this time
If distributors will not be added to the registration at this time, they must be added later through a modification process.
3. Warehouses Notice (Aviso de Funcionamiento) and Health Quality Manager Notice (Aviso de Responsable Sanitario) for the MRH, and for any distributors in Mexico that will be added to the sanitary registration at this time
All Mexican distributors are legally required to have these notices. An electronic copy of the notices is sufficient for the registration.
4. 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.
5. Manufacturing agreement, if contract manufacturers are involved with the finished product
Simple copy of the document,
6. Label and Label design
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.
7. Technical monography. Summary prepared and signed by the manufacturer, that contains at least the following information: • Commercial name • Generic name • Description of the Medical Device (Structure, properties, operation principle) • Full scheme of the devices, including: Modules, parts or components and its description, function and materials • Finished product specifications • Overview of the manufacturing process • Overview of the sterilization process (if applicable) • Overview of the biocompatibility tests (if applicable) • Overview of the shelf life testing (if applicable) • Description of the primary and secondary packaging (if applicable) • List of all the presentations, codes and/or models • Intended use • List of all components and accessories (if applicable) • Overview of the clinical tests • Bibliographic references
This document must describe the device perfectly. Besides, this monography must provide evidency that the medical device is compliant within specifications and has approved tests and applicable standards. The devices included in this document must match the other submitted documents, such as EIR (Establishment Inspection Report), CFG (Certificate to Foreign Government), MDL (Medical Device License), etc. For the overviews to be acceptable, they must be specific about the product, including the lot number, device names, test conditions, acceptance criteria, results and conclusions, as applicable.
8. Instructions for use, leaflet or operation manual, as applicable (in Spanish)
At least the following information must be provided: • Name • Description of the product • Intended Use and directions of use • List of product components or parts (if applicable) • Assembly and disassembly instructions (if applicable) • Operation and clean up instructions (if applicable) • Operation conditions and storing • Precautions, warnings,cautions, contraindications and adverse events (if applicable) • Other as applicable (Maintenance, calibration, preparation,, etc.) • For contrast media, indicate route of administration, pharmaceutical form and content of active ingredient per dose unit.
9. Certificate of Analysis (CoA) The certificates that the manufacturer provides to demonstrate that the finished product (or raw material) meets the established acceptance criteria in order to be released for sale. The document must include: tests performed on the finished product prior to release, acceptance criteria and results. The CoA must be on the letterhead of the product manufacturer, must include the manufacturer’s name and address, must have information to identify the product (e.g. name, lot number) and must be signed by the Qualtiry Control responsible person
Certificates of Analysis for the finished product are mandatory by COFEPRIS for the submission. Certificates of Analysis for the raw materials are required in cases where the raw material comes into contact with the human body. Certificate of Conformance or the 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.
10. Tecnovigilance Report
Report summarizing latest post marketing surveillance of the product. It includes all adverse events recorded since the product was first made available on the market (if applicable). It also includes the corrective and preventive actions taken.
11. Risk analysis Issued in the design/development and development of the medical device, demonstrating foreseen adverse incidents which should be included in the labels, IFU and/or Operating Manual
This doesn’t need to be submitted to COFEPRIS, but it needs to be kept on file by the Mexican Registration Holder.
12. Representation letter issued by the manufacturer, for any company to act as your Mexican Registration Holder
Original or Certified Copies are required
13. Distribution letter for each distributor that you are appointing to the registration
Original or Certified Copies are required
14. **Legal documents - only applicable for FDA approved products**
This is applicable for those products considered Medical Devices or IVDs by the FDA and were considered by the FDA as Class I, II or III
15. Certificate to Foreign Government (CFG)
Original or Certified Copy. The CFG must include the medical device to be registered in Mexico. It should include all the codes or presentations listed in the Mexican dossier It must be valid upon the dossier submission
16. Establishment Inspection Report (EIR)
Original or Certified Copy. The EIR correspond to the last audit performed by the FDA to the manufacturing facility to confirm GMPs. MDSAP or ISO13485 is also accepted.
17. Approval document by the FDA
Original or Certified Copy. The document that proves that the device to be registered in Mexico is in compliance with the directives in USA. For class I devices, it may apply the premarket notification 510(k) or the 510(k) exemption list.
18. **Legal documents - only applicable for Health Canada approved products**
This is applicable for those products considered Medical Devices or IVDs by Health Canada and were considered by Health Canada as Class II, III or IV. Products considered Class I by Health Canada are not eligible for the Equivalency Route.
19. Medical Devices License (MDL)
Original or Certified Copy. License issued by Health Canada that proves the device to be registered in Mexico has been approved in Canada. It must match the product and its presentations to be registered before COFEPRIS.
20. CAN/CSA ISO 13485 : 2016 certificate
Original or Certified Copy. The certificate must include the SCC seal, that demonstrates that the registrar has been recognized by the Canadian MoH
21. ISO 17021 certificate
Simple copy. Certificate of the Management Systems Accreditation Program issued by the SCC that shows the scope of the registrar who performed the audit and issued the ISO 13485 certificate.
22. Certificate of Accreditation
Original or Certified Copy. Issued by the SCC for the registrar that issued the ISO 13485 certificate. Must be valid at the moment of the submission to COFEPRIS
23. **Legal documents - only applicable for MHLW Japan approved products**
This is applicable for those products considered Medical Devices or IVDs by the MHLW in Japan and were considered by the MHLW in Japan as Class II, III or IV. Products considered Class I by the MHLW in Japan are not eligible for the Equivalency Route. If you use the documents approved by the MHLW in Japan, the Technical summary is not required.
24. Free Sale Certificate
Original or certified copy. Coded certificate issued within the last year, including the device to be registered before COFEPRIS.
25. Export Notification
Original or certified copy. It must include: - Description - Intended of use - Codes or presentations - Formula and/or compositions, when applicable - Shelf life, when applicable - Sterility period, if applibable - Primary and secondary packaging description
26. Certificate issued by the Registered Certification Body
Original or certified copy. It must include: - Description - Intended of use - Codes or presentations - Formula and/or compositions, when applicable - Shelf life, when applicable - Sterility period, if applibable - Primary and secondary packaging description