Mexico's regulatory authority, COFEPRIS, has introduced a landmark agreement to modernize its regulatory processes. For medical devices, multiple submission categories for new registrations and renewals are now consolidated into a single, unified procedure. This reform streamlines submissions and shortens review timelines considerably. Additionally, the agreement introduces updated requirements for advertising notices.
On August 11, 2025, the Agreement establishing actions for the simplification of procedures before the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) was published in the Official Gazette of the Federation (DOF).
On July 18, 2025, COFEPRIS published the Agreement outlining the General Guidelines for the application of the Abbreviated Regulatory Pathway for granting sanitary licenses for medical devices and drugs.
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.
In foreign trade, competitiveness and operational efficiency largely depend on effective document management. Among the most important documents is the certificate of origin, which certifies the country where a product was manufactured and, in Mexico’s case, is essential for obtaining tariff reductions or exemptions under free trade agreements.
Mexico's regulatory authority, COFEPRIS, has introduced a landmark agreement to modernize its regulatory processes. For medical devices, multiple submission categories for new registrations and renewals are now consolidated into a single, unified procedure. This reform streamlines submissions and shortens review timelines considerably. Additionally, the agreement introduces updated requirements for advertising notices.
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.
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.
