Class I – 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 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 distirbutors 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 Holder. 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
Applicable if contract manufacturers are involved with the finished product. Simple and copy of the documents.
6. Labels 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. General information
Document prepared by the manufacturer that contains at least: commercial name, generic name, general description, list of presentations, codes and/or models, intended use, category and classification based on sanitary risk level, list of the components and accesories, method of sterilization used, finished product specifications, physical or pharmaceutical form and composition or quali-quantitative formula.
8. Instructions for use, leaflet, or operation manual (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, assembly and disassembly instructions, operating and clean up instructions, operation conditions and storing, warnings, cautions, contraindications and adverse events, other as applicable (maintenance, calibration, preparation), 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
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)
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
Report of laboratory testing to verify that the specifications, safety and efficacy are met, based on International pharmacopeias, international standars or in-house methods (including the validation method).
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 porposed primary package, supporting the expiration date.
18. Biocompatibility tests and/or pre-clinical studies, if applicable
For every 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. Performing testing for IVDs (In-Vitro Diagnostic Devices)
Linearity, precision and accuracy, are common resports to cover this request.
21. Technovigilance Reports
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 and 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).