On July 11, 2025, COFEPRIS published a landmark Agreement in the Official Gazette of the Federation, marking a decisive step toward the nationwide simplification and modernization of sanitary procedures.
On July 7, 2025, Mexico’s regulatory authority, COFEPRIS, issued a new decree that substantially revises the classification framework for medical devices, thereby formally repealing the agreements published in 2011 and 2014.
COFEPRIS has implemented a series of simplification and modernization measures aimed at streamlining procedures and reducing the regulatory burden for establishments. These actions are part of the federal government’s regulatory improvement policies. This update specifically applies to the Operating License.
COFEPRIS has published a new agreement recognizing the evaluations and approvals from key international regulatory authorities and the WHO Prequalification Program for sanitary registrations of medicines and medical devices. This move, effective 60 business days after publication, aims to expedite access to quality health inputs by adopting a "reliance" approach, simplifying import procedures for essential products during health crises.
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.
Dietary supplements are defined as products intended to increase or complement the total dietary intake, or to supply one or more of their components. COFEPRIS is the authority in Mexico responsible for regulating these products and for establishing the labeling requirements they must meet to be marketed 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.
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.
