COFEPRIS Enables Regulatory Reliance Through Abbreviated Pathway

On July 18, 2025, COFEPRIS published the Agreement outlining the General Guidelines for the application of the Abbreviated Regulatory Pathway for granting sanitary licenses for medical devices and drugs. This initiative aims to streamline the regulatory evaluation process by recognizing the equivalence between COFEPRIS's procedures and those of designated Reference Regulatory Authorities (RRAs), as defined in the Agreement.

Update

To use this pathway, the Medical Devices must have identical characteristics to those authorized by the RRA in terms of quality, components, and results of quality, safety, efficacy, or performance studies. They must also present complete legal and technical information, including the current marketing authorization from the RRA issued within a period of no more than 5 years.

COFEPRIS will have a maximum period of 30 business days to issue a resolution on the application for sanitary licenses of Medical Devices under the Abbreviated Regulatory Pathway.

Regulatory Framework

Under the provisions of Article 4 of the Political Constitution of the United Mexican States; Articles 3, 17 bis, 194, 194 bis, 204, 222 and 376 of the General Health Law; Article 4 of the Federal Law of Administrative Procedure; Article 161 bis of the Health Supplies Regulations.

Effects from the RA update

Starting in September 2025, the Abbreviated Regulatory Pathway will be available for applications for sanitary licenses of Medical Devices and Drugs that have been authorized by one of the Reference Regulatory Authorities (RRAs) of the member countries of the Management Committee of the International Medical Device Regulators Forum (IMDRF) and the full members of the Medical Device Single Audit Program (MDSAP) for Good Manufacturing Practice Certificates.

Written By:

Mauricio Amaro

 

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