In Mexico, the Official Mexican Standard NOM-241-SSA1-2025, Good Manufacturing Practices for Medical Devices, has been published, updating the previous version issued in 2021. This modification, in addition to providing more explicit guidelines, aims to enhance regulatory alignment at the international level.
On March 20th of this year, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) published the Guidelines that define the requirements for Certificates of Good Manufacturing Practices (GMP) or equivalent documents, necessary for sanitary registrations, renewals, and modifications.
The Federal Commission for Protection against Sanitary Risks (COFEPRIS), through an Agreement published in the Official Gazette of the Federation (DOF) on March 27, 2025, will simplify health supplies procedures. Starting 15 working days after publication, procedures for establishment operation notices (COFEPRIS-05-006) and modifications/cancellations (COFEPRIS-05-007) will be merged, and the requirement to submit the "Operation Notice, Sanitary Responsible, and Modification or Cancellation Notice" form and the "Original Responsible Notice, for the case of sanitary responsible cancellation" will be eliminated.
On December 23, 2024, COFEPRIS published on its website a guide for self-verification of establishments in the cosmetic industry.
The purpose of this guide is to outline the key points to consider for regulatory compliance applicable to all stages of a cosmetic product, from manufacturing and storage to marketing and distribution. It also includes points to consider when receiving a sanitary verification visit from the competent authority.
In the medical device sector, safety and regulatory compliance are fundamental to ensuring quality and protecting patients. A key aspect of this process is traceability within the supply chain. As distributors, sharing updated information, such as the Notice of Operation and the Registration of the Tecnovigilance Unit, with the sanitary registration holder is not only a regulatory obligation but also an essential practice to ensure operational continuity and avoid setbacks in procedures with COFEPRIS.
The Ministry of Health in Mexico is proposing changes to a standard (NOM-240-SSA1-2012) regarding medical device safety and reporting. The draft standard strengthens reporting requirements for manufacturers, distributors and adds new responsibilities. Public feedback is welcome to evaluate the impact of the proposed changes.
