COFEPRIS adopts the MDSAP and NOM-241 equivalence
The publication in the Official Gazette of the Federation (DOF) refers to the recognition of the Medical Device Single Audit Program (MDSAP) as equivalent to the Certificate of Good Manufacturing Practices (GMP), whose conformity assessment is based on NOM-241-SSA1-2025 Good Manufacturing Practices of Medical Devices. The purpose is to eliminate duplication of conformity assessment of the Quality Management System (QMS), including inspections and audits of manufacturing sites whether or not they are within the national territory.
Update
On November 11th of this year, the DOF published the Interpretation Criteria for Mexican Official Standard NOM-241-SSA1-2025, Good Manufacturing Practices for Medical Devices, effective the next business day following its publication. Its purpose is to expedite regulatory procedures in the medical device sector.
This publication recognizes as equivalent the conformity assessment of the aforementioned Standard regarding the QMS in section 5 and any related QMS, including inspections and audits and the MDSAP, which is aligned with the internationally recognized ISO 13485:2016 standard for quality management systems applicable to medical devices.
Regulatory Framework
The evaluation criteria could be considered part of the steps to consolidate what was published on July 17th, 2023 (COFEPRIS - Circular CFS-305-2023), which mentioned the need to harmonize the regulation of medical devices. This circular is a proposal driven by international agreements, such as the USMCA (United States–Mexico–Canada Agreement) - Annex 12-E and the Pacific Alliance.
The Criteria partially maintains the same precepts as that circular and adds the regulatory best practices (reliance) whose guidelines are found in the Agreement issuing the General Guidelines for the application of the abbreviated regulatory pathway for granting sanitary registrations for health supplies, in which the requirements, tests, and evaluation procedures issued by reference regulatory authorities and the World Health Organization's prequalification program are recognized as equivalent (published in the Official Gazette of the Federation on July 18th of this year).
In that Agreement, the requirements, tests, and evaluation procedures issued by reference regulatory authorities and the World Health Organization's prequalification program for the regulation of medical devices are considered equivalent. Therefore, in this proposal, the MDSAP and the certification by NOM-241-SSA1-2025 are recognized as equivalent, and may be applicable to both foreign and national manufacturing sites, regardless of where the products obtained in those establishments are marketed, which is in accordance with the regulations published in the Agreement that issues the Guidelines for the presentation of documents that guarantee good manufacturing practices for drugs, medicines and medical devices that accompany the applications for new sanitary registrations, their extensions and modifications, published on March 20th, 2025.
Effectos from RAUpdate
For applications for sanitary registration of medical devices, whether through the abbreviated or standard procedure, the conformity assessment obtained through the MDSAP for establishments located within or outside the national territory may be submitted, thereby eliminating duplicate regulatory procedures. This demonstrates that the Commission for Protection against Sanitary Risks (COFEPRIS) has formally adopted a regulatory reliance approach.
Written By:
Alma Vargas
About IPS
Our Quality Assurance and Regulatory Affairs team helps medical device manufacturers assess the compliance level of their manufacturing sites using various methodologies, obtain GMP certification, and secure sanitary registration through both standard and expedited processes in Mexico. We have in-depth knowledge of the local regulatory framework and a proven track record of success. We offer a wide range of services to meet your specific needs. Contact us at info@insumosparasalud.com for more information.