The Ministry of Health, through COFEPRIS, released a proposal on March 3rd that aims to modify the Official Mexican Standard NOM-137-SSA1-2008 for medical device labeling.
Regulatory Update
COFEPRIS is undergoing a significant transformation under "Plan México," aiming to become an agile, transparent, and internationally harmonized agency. This includes a push for 100% digitization of procedures, fostering clinical research, streamlining regulatory pathways, and modernizing the regulatory framework to boost investment and ensure public health.
Regulatory Update
The simplification of procedures for the application of the advertising permit for products and services, as well as for health supplies, and for the export support certificate procedures, has been published.
Regulatory Update
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.
Regulatory Update
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.
Regulatory Update
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.
