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.
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:
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.