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Manufacturing or Selling Medical Devices in Mexico: A Regulatory Conundrum

As indicated, to be imported into Mexico, all medical devices must be registered through the Sanitary Registration process with the Mexican Ministry of Health. To start the registration process, an application is required along with the proper fees according to the risk assessment classification and according to the Mexican Federal Law on Fee Payment. The following documents at a minimum are required to start the ball rolling:

- Scientific and technical information that describes the characteristics of the device and demonstrates its safety and efficacy
- A copy of the label, in Spanish, with information as required by Official Mexican Norms
- Instructions for the device’s use or operation manual, also in Spanish
- Description of manufacturing process
- Certificate of Good Manufacturing Practices (GMP), i.e. Declaration of Conformance. Certificate of GMP must be issued by the health authority of your country of origin or an equivalent document issued by the body authorized by the country of origin.
- Laboratory test results that verify the product’s specifications
- Bibliographic reference
- Certificate of Free Sale (or Certificate for Foreign Government) issued by the authority of the country of origin
- Original or certified copy of the original letter of representation issued by the manufacturer

Instructions for Use and Stability Testing
User instructions are required for those medical devices needing unambiguous instructions for proper use or operation and which do not require a more detailed operating manual. Classes II and III implantable devices must be accompanied by a list of materials used in the medical device, including the names and composition of materials and their role. For medical devices that require an expiration date, the registrant must present a stability study, reviewed and signed by the manufacturer’s quality control officer. The manufacturer shall establish the methodology and test conditions to ensure that original features are retained during the product life cycle. Registrants must present available information on adverse events that have arisen during marketing or use wherever the product is used. Sterility reports where applicable are also required.

Import Documentation
What follows is a list of documents that must be translated into Spanish and presented in order for medical devices to receive a Sanitary Authorization and for the imported product to be released from Mexican Customs.

    • Import Declaration
    • Commercial invoice
    • Bill of lading or airway bill
    • NAFTA certificate of origin, as applicable in order to obtain NAFTA tariff benefits.

What I have done with U.S. exporters/manufacturers is to have them send the required export documentation to their customs’ broker for review in advance of preparing their goods for shipment. After checking all of the documents, Mexican customs’ services may conduct an arbitrary shipment inspection before yielding final clearance. Quality System Requirements: COFEPRIS customarily doesn’t come on-site, but under new draft guidance, that may change. Presently, to meet the GMP, a manufacturer can use ISO 13485.

In conclusion, these are the steps to be taken to register and then conduct business in Mexico:

    1. Determine the device’s class.
    2. Appoint a local registration holder.
    3. Acquire cGMP Certificates.
    4. Assemble documents to attach to the application for the device.
    5. Submit all requisite documents to COFEPRIS.
    6. Approval of dertificates. Once COFEPRIS approves the certificates, it will post the confirmation and registration number on the Ministry of Health’s website. If COFEPRIS has any issues with the registration, it will inform the manufacturer. The original time limits for approval are revised, and moving forward, it then may take an inordinate amount of time to approve a registration.
    7. Follow label requirements.
    8. Approval of dossier. No matter the device class, if the dossier is approved, then a certificate is issued by COFEPRIS and confirmed/posted.
    9. Designate a distributor and begin marketing your device.

The certificates issued by COFEPRIS are valid for five years. … y le deseo la mejor de las suertes! Paciencia Práctica (and I wish you the best of luck! Practice patience.)

This article was accompanied by two other articles as part of our emerging markets feature in the October issue of BONEZONE. They are: International and Domestic Manufacturers Compete to Serve Growing Asian Population and Brazil Remains Among Top Ten Markets, Despite Economic Downturn.
 

John Gagliardi has had success over the past 45 years in the medical device and pharmaceutical industries because of his practical approach to process-orientation and business. He has been actively involved in research and development, quality assurance, training, operations, process architecture, FDA inspections and regulatory affairs. Mr. Gagliardi specializes in building systems in a compliant and business-ready manner. Mr. Gagliardi can be reached at This email address is being protected from spambots. You need JavaScript enabled to view it..

MidWest Process Innovation, LLC
www.midwestprocessinnovation.com

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