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.
Importing medical devices into Mexico involves a series of steps regulated by health and customs authorities. Due to their impact on public health, these products must meet specific requirements from their origin through to commercialization. Therefore, proactive planning and specialized advice are essential to avoid setbacks.
