GRP Mexico can help you obtain COFEPRIS medical device registration and approval to sell your product on the Mexican market.
COFEPRIS, Mexico’s the second largest medical device market in Latin America after Brazil and can be a lucrative target for medical device and IVD manufacturers. However, registering a device or IVD in Mexico can be a long and difficult process. COFEPRIS, the division of the Mexican Ministry of Health responsible for overseeing medical devices and IVDs, provides limited information about the online registration process.
The medical device approval process in Mexico:
The first step towards registration in Mexico is to classify your medical device. The COFEPRIS classification rules are adapted from the European rules, with some differences that are unique to Mexico.
Medical devices are classified based on increasing risk, using a three-tier system:
- Class I
- Class II
- Class III
COFEPRIS also provides a list of products considered low-risk Class I, which are still regulated but have faster review and approval times.
Grouping families can have an impact on the number of registrations required and can be advantageous if you want to register different models or variations of the same device.
GRP Mexico offers initial classification and grouping determination based on guideline references, device equivalence and our experience in grouping hundreds of devices.
Once classified the required documents of each category are developed according to the regulations and the technical dossier is preprepared accordingly.
Local Testing of the product may or may not be required by COFEPRIS. Usually, the request to test is communicated during the COFEPRIS product review process. If requested by COFEPRIS, timelines are tight and decisive action from client for shipment of samples and payment of the local testing is required to answer queries in a timely manner. Local Testing might be possible prior submission, but many institutions in Mexico will not agree to test the product without an order from COFEPRIS.
GRP México Services
GRP Mexico can help with device registration and IVD in Mexico. The GRP Mexico team is made up of experienced bilingual management professionals, so we understand what it takes to get your device approved in the most efficient way possible. Let’s go:
- Local Representation
- Determine the classification and registration route for your medical device or IVD.
- Help define a grouping strategy for your directory, if applicable.
- Determine the documents required for your registration journey.
- Act as an Independent Registered Owner in Mexico. Prepare and submit the application to COFEPRIS.
- Answer COFEPRIS’ questions during submission.
- Mexico is a growing Latin American market that relies almost entirely on imports. This makes it a lucrative market for device manufacturers.
- Warehousing and Storage
- Importation and Customs Clearance
Learn more about Cofepris
We are a global consulting firm Headquartered in Boston Massachusetts USA that provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical and medical device companies worldwide to register their products with the Mexico's Cofepris the local Health Authority (HA)
We are a global consulting firm Headquartered in Boston Massachusetts USA that provides Regulatory Affairs, Quality, Clinical and Safety services to pharmaceutical and medical device companies worldwide to register their product with the Food and Drug Administration (FDA) the local Health Authority (HA)
About Global Regulatory Partners Group
Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.
GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations.