MEXICO CITY – Mexico is updating its medical device classification process, allowing the deregulation of more than 2,000 products considered low risk. The country’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, according to BMI Research. 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.
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