This Decree, published in the Official Gazette of the Federation on June 2, 2025, establishes a regulatory framework aimed at promoting investment within Mexico to strengthen the pharmaceutical industry, the production of medicines, health inputs, and medical devices, as well as fostering scientific research. Its main objective is to reduce import dependency and ensure the availability of these essential products, using consolidated public procurement as a lever for economic development.
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.
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.
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.
To import dietary supplements into Mexico, it is essential to understand the applicable regulations, among which the prior sanitary import permit stands out.
This permit, issued by COFEPRIS, authorizes the entry of food, dietary supplements, and non-alcoholic beverages that comply with Mexico’s current sanitary legislation, allowing their commercialization and distribution in the country.
The Federal Commission for Protection against Sanitary Risks (COFEPRIS) is entrusted with the crucial task of overseeing and regulating products and services intended for human consumption, such as food supplements, to ensure their quality and safety. This article explores the surveillance actions undertaken by COFEPRIS and the key aspects companies should consider.
