Class II – Standard route
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
This is provided by your MRH Send notarized, original or certified copy of the power of attorney in favor of the Legal Representative of the Registration Holder established in Mexico.
5. Manufacturing agreement, if contract manufacturers are involved with the finished product
Simple copy of the document.
6. 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.
7. General Information
Document prepared by the manufacturer, that contains at least the following information: • Commercial name • Generic name • General Description of the Medical Device • List of Presentations, codes and/or models • Intended use • Category and Classification based on sanitary risk level (will be provided to you by the consultant) • List of all the components and accessories (if applicable) • Method of sterilization used (if applicable) • Finished product specifications • Physical or pharmaceutical form and composition or quali-quantitative formula (if 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. Composition, description or diagram of functional parts of the product
10. Document containing statement of the quali-quantitative formulation by unit of measurement, dose or percent (for formulated products) signed by the Health Quality Manager
11. Manufacturing Process Information issued and validated by the Health Quality Manager
An overview of the manufacturing process and flow diagram of the manufacturing process.
12. Sterilization information for products that carry the label "sterile"
Summary of sterilization process, validation report and certificate of sterility.
13. Packaging specifications – Primary and secondary packaging descriptions (photos, materials, measurements)
Leakage or hermeticity test report are required when applicable
14. Storage indications – Any temperature, pressure and/or humidity conditions for storage and transport of the device
This information could be included in the labels or IFU
15. Laboratory testing
Reports of laboratory testing to verify that the specifications, safety and efficacy are met; based on International pharmacopeias, international standards or in-house methods (with its respective method validation).
16. 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.
17. Stability studies for medical devices that have an expiration date given their characteristics and intended use
Summary and conclusions for the Stability Studies on the proposed primary package, supporting the expiration date.
18. Biocompatibility tests and/or pre-clinical studies, if applicable
For every raw material or finished product in contact with the human body.
19. Clinical Studies
Summary and conclusions of clinical studies, including literature for novel medical devices or for recently added indications for use.
20. Performance testing for IVDs (In-Vitro Diagnostic Devices)
Linearity, precision and accuracy, are common reports to cover this request.
21. Technovigilance 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.
22. 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.
23. Representation letter issued by the manufacturer, for any company to act as your Mexican Registration Holder
Original or Certified Copies are required
24. Distribution letter for each distributor that you are appointing to the registration
Original or Certified Copies are required
25. Free Sales Certificate (FSC) or an equivalent document issued to the manufacturer. FSC must be issued by the Health Authority from the Country of origin
Original or Certified Copy.
26. Good Manufacturing Practices Certificate (GMPC) or its equivalent (i.e. ISO 13485, CE Mark)
Original or Certified Copy. Also provide legalized copies of the GMPC for all your contract manufacturers (if applicable).