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.
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.
In Mexico, cosmetic product labeling is regulated to ensure consumers receive accurate and sufficient information, enabling them to make safe and informed purchasing decisions. Compliance with these regulations is essential for manufacturers and importers looking to sell their products in the country.
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.
On April 2, 2025, the United States government announced the implementation of "reciprocal tariffs" on multiple countries, establishing a base tariff of 10%. However, a week later, a 90-day pause was applied for most trading partners; nevertheless, tariffs on China were simultaneously increased. This decision is part of a strategy aimed at correcting trade balance imbalances and strengthening the U.S. domestic industry.
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.
