The joint statement issued by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and the Agency for Digital Transformation and Telecommunications (ATDT), dated July 8, 2025, announces the publication of two important agreements in the Official Gazette of the Federation (DOF), as part of the regulatory modernization strategy framed within the "Mexico Plan."

These actions have the fundamental purpose of simplifying administrative procedures, promoting transparency, accelerating response times, and updating technical criteria for sanitary classification, without undermining the technical and scientific rigor of the regulatory authority.

The first agreement establishes concrete measures to simplify procedures carried out before COFEPRIS. The second agreement refers to the reclassification of low-risk medical devices.

WHOM DOES IT IMPACT?

The direct impact is felt by companies in the healthcare and pharmaceutical sectors, healthcare officials and professionals, regulatory authorities, consumers, and users of the healthcare system.

CONCLUSION:

The impact is significant not only due to the magnitude of the changes, but also due to the range of actors involved and the structural benefits it introduces for the Mexican healthcare regulatory system.