March 2, 2026
By Pedro Omar Sánchez Neri and Evangeline Loh
The Mexican regulatory registration and compliance process for medical devices has undergone significant changes in the past year. Below, Emergo by UL explains how medical device manufacturers seeking market access in Mexico will be affected.
In July 2025, Mexico’s medical device market regulator COFEPRIS promulgated the most recent version of the Reference Regulatory Authorities (RRA) registration process and equivalence agreement, effective Sept. 1, 2025. The prior equivalency was discontinued and the submission framework was updated into a more concise set of submission keys (homoclaves), as discussed in a previous Regulatory Update. The RRAs which could be leveraged were described in the initial June 11 agreement and later confirmed in the final one from July 18.
The RRAs are the International Medical Device Regulators Forum (IMDRF) Management Committee and full members of the Medical Device Single Audit Program (MDSAP): Australia, Brazil, Canada, China, European Union, Japan, Russia, Singapore, South Korea, Switzerland, the U.K. and the U.S.
Submission requirements for RRA equivalence
The technical information section is broad, but clear and the agreement outlines explicitly that the documents submitted must be in accordance with the authority from which the equivalence is leveraged. The Certificate of Free Sale from the RRA and the Certificate of Analysis continue to be required. In addition, as to be expected, the Quality Management System (QMS) certificate and authorization per the RRA need to be included. Of course, labeling should be provided in Spanish and compliant to NOM-137.
In addition, the Technolovigilance Report, even though not part of the leveraged RRA submission, is still expected. Last, the submission is still paper-based and still in Spanish or English.
Timeline for COFEPRIS review of RRA submission
The new RRA equivalence similar to the previous equivalence agreements states the timeline for COFEPRIS review as 30 calendar days. However, based on Emergo experience from COFEPRIS’s review of the previous equivalence agreement, reviews exceeded one year. This was already shorter than the standard submission review timelines.
Only time will tell what to expect with COFEPRIS and RRA equivalence reviews.
Conclusion: A "prevailing submission route" for Mexico
COFEPRIS appears committed to improving the medical device regulatory system in Mexico. As we mentioned in our webinar, this RRA equivalence submission route is expected to be the “prevailing submission route.” And, extending the validity of renewals to 10 years also helps.
Emergo continues to monitor these medical device developments in Mexico and will certainly share updates as we learn more about the new RRA equivalence route.
Pedro Omar Sánchez Neri is Regulatory Services Program Manager and Evangeline Loh is Global Manager, Regulatory Affairs at Emergo by UL.
