Mexico is the largest medical device importer in Latin America and is a key market for medical device manufacturers not only in North America but also around the world. Mexico’s medical device registration regulations may seem complex, and they are mostly only published in Spanish. Compared to other countries in Latin America, however, Mexico harmonized its medical device regulations to ensure that the Mexican health care system has access to the same state-of-the-art technology as many others do. In addition, as a result of NAFTA, the North American Free Trade Agreement, imports into Mexico from the United States and Canada enjoy no tariffs. However, companies in Belgium, china, France, Germany, and Japan also import many devices to Mexico.
Medical Device Registration
In Mexico, the agency charged with overseeing medical devices is the Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS). COFEPRIS has a large mandate, overseeing not only medical devices but also the safety and import of drug and food products into Mexico. COFEPRIS promulgates regulations regarding the importation of medical devices and other medicinal products and works to ensure their safety in the Mexican marketplace.
Devices Not Already Registered in the United States or Canada
Mexico has slightly different regulatory schemes for medical devices already registered in the United States and Canada and those that are not. While devices that are FDA- or Health Canada-approved enjoy a faster response time and a streamlined registration procedure, devices that lack these approvals can still receive approval and registration in Mexico.
Step 1: Determine the Device’s Class
The first step to register medical devices in Mexico is to determine the class of your device. While the required documents are similar for each class, the time and cost differences can be significant. Therefore, it is important to correctly determine the class of the device, following the rules promulgated by COFEPRIS.
Medical Device Classification
The Mexican General Health Law separates medical devices into six families based on their function and purpose. The six families of medical devices are:
• Medical equipment: Appliances, accessories and instruments for medical use;
• Prosthetics, orthotics and functional aids;
• Diagnostic agents;
• Dental supplies;
• Surgical materials; and
• Hygiene Devices.1
Mexico further classifies the medical device families into three risk-based classes.
Mexico divides its six families of devices further into three risk-based classes. These classes are:
• Class I: those that are known in the medical practice with a proven safety and efficacy record;
• Class II: those that are known in the medical practice with variations in their materials, and are not usually in the human body for more than 30 days; and
• Class III: those that are known in the medical practice and are usually in the human body for more than 30 days.
The Comité Técnico de Insumos para la Salud (Health Products Technical Committee) issued 20 rules COFEPRIS uses to determine the class of the device. The rules can be grouped into specific devices:
• Non-invasive Devices: Rules 1-4;
• Invasive or Implantable Devices: Rules 5-8;
• Active Implantable Devices: Rules 13-18; and
• In Vitro Diagnostic Devices (IVDs): Rules 19 and 20.
Correctly determining the device’s class is important. COFEPRIS has the final word on a device’s class.
Step 2: Appoint a Local Registration Holder
Once you determine your device’s class, appoint a local Registration Holder. A manufacturer needs a Registration Holder if the device is manufactured outside of Mexico and the manufacturer has no locations in Mexico. A Registration Holder must be licensed by COFEPRIS and must have a location in Mexico. Many manufacturers appoint their importers as registration holders. Registration holders also coordinate importing the device, and so must maintain warehouses that comply with COFEPRIS’ specifications.2 The Registration Holder will submit the applications to COFEPRIS.
Step 3: Acquire GMP Certificates
The next step to register a medical device in Mexico is to acquire Good Manufacturing Practices certificates. According to the Reglamento de Insumos para la Salud, Article 180, foreign manufacturers must submit a Certificate of Good Manufacturing Practices. This certificate may be one that COFEPRIS issues if the manufacturing facility is located in Mexico. If the manufacturing facility is not located in Mexico, the Reglamentos state that an ISO 13485 certificate issued by an authorized body is sufficient to show Good Manufacturing Practices. Additionally, a Certificate of CE Marking for medical devices issued by an authorized body in the European Union can show Good Manufacturing Practices. LNE/G-MED is authorized to issue both ISO 13485 certification and CE marking, so your LNE/G-MED certificates can be used to market your device in Mexico.
Step 4: Compile Documents to Attach to the Application for the Device
The next step is to compile and submit the additional documents needed in the application for the device. The required documents are found in Reglamento de Insumos para la Salud, Article 179. In addition to the documents required in Article 179, foreign manufacturers must also submit:
• Certificate of Free Sale issued by the country of origin;
• GMP certificate issued by an authority of the country of origin (or COFEPRIS, if the device is not marketed in any other country yet);
• An original certificate of analysis from the manufacturer on the manufacturer’s letterhead;
• If the device isn’t manufactured by the parent company, a letter of representation describing the relationship between the manufacturer (who is actually applying) and the parent company.
Step 5: Submit All Required Documents to COFEPRIS
Once all the documents are ready, the Registration Holder submits the documents to COFEPRIS. According to Article 1793, COFEPRIS must make decisions on the registrations within 30 days for a Class I device, 35 days for a Class II device, and 60 days for a Class III device. While there are some indications that it may take longer, COFEPRIS promulgated a couple new regulations in order to streamline the process and keep it efficient. First, COFEPRIS introduced a faster application process for those devices already registered in the United States and Canada. Second, COFEPRIS excepted 1700 devices from the definition of “medical device,” excepting them out of the registration requirements. Third, COFEPRIS amended the regulations to state that for Class I devices, an application is considered approved even if there is no response from COFEPRIS. Class II and III devices, on the other hand, are considered rejected with no response from COFEPRIS within the specific time requirements.
Step 6: COFEPRIS Issues Certificates and Posts Confirmation on Ministry of Health Website
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 in writing.4 At this point, the time limits for approval are lifted, and it may take any amount of time to approve a registration.
Devices Already Registered in the United States and Canada
In order to facilitate importing medical devices into Mexico, COFEPRIS instituted a program where it expedites registration applications from devices that are already approved in the United States and Canada. The agreement, entered into in October 2010, states that the procedures and requirements required by Mexico are equivalent to those required by the FDA and Health Canada. As a result, manufacturers whose devices are already registered in the United States or Canada can enter Mexico much faster than those without FDA or Health Canada approval. According to the Agreement, COFEPRIS must review these applications and render a decision within 30 days. COFEPRIS completes these applications within 30 work days of when it receives them, and if the device is a Class I device, then they are deemed accepted if the manufacturer doesn’t hear anything from COFEPRIS in that amount of time. The documentary requirements are essentially the same as with other registration applications, with a few exceptions:
FDA-Approved Class I Devices
For FDA-approved Class I devices, manufacturers must include all the necessary documentation, and also:
• A Certificate to Foreign Government from the FDA certifying the device was accepted by the FDA, translated into Spanish;
• The last establishment inspection report that was performed, translated into Spanish; and
• The FDA document specifying the device was approved and the class of the device, translated into Spanish.6
FDA-Approved Class II and III Devices
For FDA-approved Class II and III devices, manufacturers must include all the necessary documentation, and also:
• A Certificate to Foreign Government from the FDA, translated into Spanish;
• The last establishment inspection report that was performed, translated into Spanish;
• Summary of the last surveillance postmarket report of the product, translated into Spanish according to Article 153 of the Regulations [Reglamento de Insumos para la Salud.]; and
• The FDA document specifying the device was approved and the class of the device, translated into Spanish.
Health Canada – Approved Class II and III Devices
Class I medical devices that are approved by Health Canada are excluded by the agreement, and so must conform to the requirements for devices that aren’t approved in the United States or Canada. For Health Canada- approved Class II and III devices, manufacturers must include all the necessary documentation, and also:
• A certified copy of the devices’ license issued by Health Canada to the manufacturer, translated into Spanish according to Article 153 of the Regulations;7
• Copy of certificate of compliance to CAN/CSA-ISO 13485:2003, translated into Spanish according to Article 153 of the Regulations;8
• Copy of the certificate of compliance to ISO 17021, translated into Spanish according to Article 153 of the Regulations;9 and
• Certified copy of Health Canada’s authorization to a third party who issued the ISO certificates, translated into Spanish according to Article 153 of the Regulations.10
Mexico, as the largest importer of medical devices in Latin America, is a hard opportunity to pass up considering the easy of entry for device manufacturers. Mexico’s medical device regulations accept ISO certifications, and don’t seem to have specific Good Manufacturing Practices requirements that may slow down the registration process. Because Mexico considers FDA and CMDCAS certificates to be equivalent to its own COFEPRIS, if a device is already certified in the United States or Canada, the process is even faster. This means that your LNE/G-MED certificates could already give you market access to Mexico. For more information on how to market your device in Mexico, contact us.
1 Ley General de Salud Article 262.
2 Reglamentos de Insumos para la Salud, Article 181.
3 Reglamento de Insumos para la Salud.
4 Guidelines for Registration of Health and Medical Devices, s. 6.1.
5 Agreement, Published in the Official Journal, Oct. 26 2010.
6 Agreement, Published in the Official Journal, Oct. 26 2010.
7 Reglamento de Insumos para la Salud
8 Reglamento de Insumos para la Salud
9 Reglamento de Insumos para la Salud
10 Reglamento de Insumos para la Salud