Achieving COFEPRIS compliance
Before medical device manufacturers can legally sell their products in Mexico, they must comply with Mexican medical device regulations set forth by the Federal Commission for Protection from Sanitary Risks (COFEPRIS).
In Mexico, it is extremely important to accurately classify your medical device prior to beginning the registration process. Improper classification can impact the regulatory approval process and its associated costs.
Determining criteria for medical device testing in Mexico
The first step towards classification in Mexico is determining if your medical device is on the COFEPRIS list of deregulated devices. If not, device classification is based on 23 rules found in "Criteria for Medical Device Classification."
Medical devices in Mexico are separated into six families based on their function and purpose. Devices are then classified based on risk as Low Risk, Class I, Class II, and Class III. The six families of medical devices include:
- Medical equipment: appliances, accessories, and instruments for medical use
- Prosthetics, orthotics, and functional aids
- Diagnostic agents
- Dental supplies
- Surgical materials
- Hygiene Devices
Grouping your medical devices into registrations for COFEPRIS
The grouping of products should also be taken into consideration when determining device classification in Mexico, as this may impact the number of registrations which will be required for your device (more registrations will increase costs).
While COFEPRIS has released some guidance documents regarding classifying and grouping product families, these complex documents are primarily in Spanish and can easily be misinterpreted. Your Registration Holder should be able to assist in determining the correct grouping and classification for your device. For example, common factors which would impact the grouping could include: accessories, additional components, being part of a kit, etc.
Emergo's consultants know how to combine the classification and grouping documents with years of practical experience working with COFEPRIS to help you find the optimal and most cost-effective registration strategy, based on your company’s needs and goals for the market.
- Our office in Mexico has worked with medical device manufacturers on over 450 submissions to COFEPRIS.
- Emergo by UL is able to determine the proper classification for your medical device and can provide an initial assessment on grouping acceptability, if necessary.
- Many manufacturers work with us on standard Third Party Review submissions, as well as the equivalency route available to certain devices already approved by the US FDA, Health Canada, or Japan.
- Our in-depth knowledge of the Mexican medical device market ensures that we provide the most efficient and cost-effective regulatory approval strategy for your device.
- We can assist you in preparing medical device registration documents that demonstrate compliance with COFEPRIS.
- Our Mexico Registration Holder services allow us to submit devices for COFEPRIS approval on your behalf.
Please contact us for more information on medical device classification and registration in Mexico.