Mexico Reclassifies Medical Devices, Deregulates 2,200 Devices

Mexico is updating its medical device classification scheme, which will allow deregulation of more than 2,200 products considered low risk.

Mexico’s Federal Commission for Protection against Sanitary Risks (COFEPRIS) said that by deregulating the lower-risk devices, it will be able to focus on enabling earlier access for innovative devices.

The announcement marks the third deregulatory listing for medical devices, following the deregulation of 1,669 in the first stage and 573 in the second stage, BMI Research said, noting that the revised device classification is a move toward harmonization with international standards.

Mexico is the leading exporter of medical devices in Latin America, and it ranks eighth internationally, according to COFEPRIS. U.S. exports to Mexico were roughly $3.4 billion, and U.S. imports from Mexico were roughly $7.6 billion, according to AdvaMed.