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Medical Device Product Registration and Approval in Mexico

​MEDICAL DEVICE REGULATION IN MEXICO

Medical Device is regulated by The Federal Commission for the Protection against Sanitary Risk (COFEPRIS) from the Secretariat of Health in Mexico. Its primary objective is to protect the population against sanitary risks, through sanitary regulation, control and promotion under a single command, that provides unity and homogeneity to the policies which are determined.

MEDICAL DEVICE REGISTRATION AND APPROVAL IN MEXICO

Medical devices are classified into 3 categories namely class I, II, and III (I being the lowest risk and III being the highest risk).

 

The registration requirements are similar to the European Union(EU) with the main focus being on documents from the technical file. An expedited registration route applies if the device has been approved in US or Canada.

Example of Approval

Source: COFEPRIS

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