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Mexico - COFEPRIS Adds Hundreds of Devices to List of Products Not Requiring Registration in Mexico

Posted on April 11th 2015 by

Mexico's medical device market regulator, COFEPRIS, recently added 573 items to its not considered medical devices, effectively removing registration as a requirement for importation, distribution or sale of these products in Mexico. Most of the products added to the no-registration list share low-risk profiles, or are components or accessories to other medical devices. Most notably, standalone software remains on the list of products not required to be registered with COFEPRIS.

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