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Mexico Updates Lists of Class Ia Devices, Third-Party Reviewers


Mexico’s medical device market regulator COFEPRIS has formally published a new list of medical devices that no longer require registration and those that qualify for new Class Ia status in the regulator’s Official Diary.

According to Emergo Group sources in Mexico City, manufacturers whose devices qualify for Class Ia classification could face a much simpler registration process, but notification as well as Mexico Registration Holder representation will likely still be required for such products.

In addition, COFEPRIS has officially released a list of approved third-party reviewers for the standard medical device registration process. (This list has yet to be published in the Official Diary, however.)

We will keep you further informed of these changes as more details emerge from COFEPRIS.

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