Manufacturing or Selling Medical Devices in Mexico: A Regulatory Conundrum

John-Gagliardi WEBEmerging Technologies
Mexico is the second largest medical device market in Latin America behind Brazil, and can prove to be a profitable focus for U.S. medical device manufacturers. Mexico is making significant steps on in-roads into the medical device industry and is ready for success. Industry analysts predict that the fabrication and selling of medical devices and related technologies will increase 75 percent over the next decade. This represents growth from $8.5 billion in 2011 to a forecasted $14.9 billion in 2020 for all medical devices.


On the Flip Side, the Registration Process is Perplexing

I’m going to be a bit negative before I discuss this provokingly worthwhile topic. I have been around the block on this subject far too many times. Registering a medical device in Mexico is very difficult and can be unpredictable. In fact, unless you have multiple influential contacts and plenty of idle time, this task sometimes seems impossible to finalize during the so-called registration process. 

 
 Definitions 

Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS):

Regulatory body in the division of the Mexican Ministry of Health (Secretaría de Salud)

North American Free Trade Agreement (NAFTA):

Under NAFTA, certain products, including most medical devices, that originate in Canada, Mexico or the U.S. can realize low or zero tariff rates when traded between these countries.
 

              

If you don’t have a local presence in Mexico, you will need to appoint a Mexico Registration Holder to serve as your in-country representative. Some Mexican distributors want to be your representative (obviously, for business reasons) but, in the long run and from my experience, give up far too early and leave your company in a place just left of limbo. Remember, a good local representative must be familiar with the import documentation and must be capable of applying for the necessary import permits. As in any export market, U.S. exporters of medical devices must do the homework before appointing a representative and, more importantly, before signing any type of agreement or contract. This has amplified importance in the case of pursuing Mexican government procurement. It has been reported in Mexico that individuals will proactively approach inexperienced U.S. companies with the false promise of knowing high-ranking officials in the Mexican government who will help them secure a purchase with public health care institutions. 


Early-on in my regulatory experiences, this happened to me. Promises made were, in my case, not kept. The whole process came to a screeching halt after much consternation. 

To make this challenge even more stimulating, little information on the registration process is available in English from COFEPRIS. So, si usted no habla o no entiende Español (If you don't speak or understand Spanish), this undertaking becomes more and more interesting, indeed. This local presence whom I mentioned should (obviously) be bilingual from a standpoint of understanding technical and medical device terminology. Understanding how the Mexican government operates would be an advantage, too.

Enough! Let’s Start Spinning Positively
Properly classifying your medical device is an important first step for any measurable success with COFEPRIS. Regulation classifies medical devices according to a three-tier risk-based classification system similar to that of the U.S. FDA and the European Union Medical Device Directives. The classification is as follows:

    • Class I devices: Those those that “are very well known in the medical field, with proveneffectiveness and safety, and that generally are not introduced into the human body.”
    • Class II devices: “Well known in the medical field, but may have a variation in the rawmaterials of which they are made, or different component composition or concentration, and that are introduced into and kept in the human body for less than thirty days.”
    • Class III devices: “New products or products recently approved in the medical field, or products that are introduced and kept in the human body for more than 30 days.”

The Mexican government recently issued a directive that allows for streamlined approval of medical devices in Mexico, provided that they have previously been approved by FDA. The directive indicates that the procedures followed by FDA in the approval of medical devices in the U.S. and Canada are equivalent to those provided by Mexican law. Therefore, applicants for approval of such devices may present evidence that they have been previously duly approved in the U.S. in order to streamline the process in Mexico. That process may take up to 30 business days, if such evidence is provided. If your device has been approved in the U.S., you may qualify for this expedited equivalency review (somewhat analogous to a premarket notification in the U.S.). Equivalency reviews require the submission of a Summary Dossier with less detailed technical information, and initial registration may be faster than the standard review process. If you are going to register through the customary review process, you must prepare a detailed Registration Dossier that includes full product technical information and pertinent testing results.


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
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