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. However, it also removes the fast-track registration routes that relied on prior approvals from the USA (FDA), Canada, and Japan. Consequently, companies must reevaluate their registration strategies for the Mexican market. Additionally, the agreement introduces updated requirements for advertising notices.
UPDATE
On August 22, 2025, the Mexican Secretariat of Health published an agreement introducing significant simplification measures for procedures managed by COFEPRIS. This initiative is part of a broader public policy on regulatory improvement aimed at reducing bureaucratic costs, increasing transparency, and streamlining processes for the regulated industry.
The core of the update is the consolidation of multiple submission types into a single, unified procedure. Specifically for medical devices, the different modalities for new registrations (national, imported, maquiladora) have now been merged into one single procedure: “Registro Sanitario de Dispositivos Médicos” (COFEPRIS-04-060).
Similarly, registrations for low-risk devices are now consolidated into “Registro Sanitario de Dispositivos Médicos Considerados de Bajo Riesgo” (COFEPRIS-04-070). In addition, all first-renewal applications are now processed under “Prórroga del Registro Sanitario de Dispositivos Médicos” (COFEPRIS-04-090).
One of the most significant impacts of this agreement is the drastic reduction in resolution times. For new medical device registrations, the review timeline for Class I devices has been reduced from 30 to 20 business days, for Class II from 35 to 25 business days, and for Class III from 60 to 35 business days. Approvals for low-risk devices have been cut in half, from 30 to 15 business days. Perhaps most notably, the timeline for registration renewals has been shortened from 120 to just 45 calendar days.
However, in a move that will reshape market access strategies, COFEPRIS has eliminated the procedures based on Equivalence Agreements. This includes pathways that previously allowed for expedited registration of devices already approved by the U.S. FDA (Class I, II, and III), Health Canada (Class II, III, and IV), and Japan’s MHLW. Going forward, all new products—regardless of prior approval in these jurisdictions—must either undergo one of the standard Mexican registration pathways or make use of the new Abbreviated Regulatory Pathway Agreement issued in July, which will take effect in September 2025.
For procedures related to medical devices, the agreement will enter into force after 180 business days (May 2026), while adaptations are made to the Cofepris platforms and systems.
Regarding the agreement mentioned above, the topic of advertising has been updated with an adjustment to the advertising notice for health supplies. This refers to the update of the name and requirements for procedure COFEPRIS-02-002-C, “Aviso de Publicidad de Insumos para la Salud, Dirigido a Profesionales de la Salud.” The updated requirements for this procedure now include the use of an online format, submission of an advertising project, and supporting documents. It has been established that this change will take effect 180 business days after its publication in the Official Gazette of the Federation (DOF)—that is, in May 2026—a transition period intended to allow sufficient time for the adaptation of systems and platforms.
REGULATORY FRAMEWORK
Ley General de Salud (General Health Law)
Reglamento de Insumos para la Salud (Regulation for Health Supplies)
Ley Nacional para Eliminar Trámites Burocráticos (National Law to Eliminate Bureaucratic Procedures)
Ley Federal de Procedimiento Administrativo (Federal Law of Administrative Procedure)
Effects from RA Update
This agreement highlights key points for business operations:
Opportunities: The consolidation of procedures simplifies the preparation of submissions by establishing a single, clear pathway for new registrations and renewals. The significant reduction in review timelines is a major advantage, potentially accelerating time-to-market and enabling quicker revenue generation. Companies with pending or planned renewals will particularly benefit from the shortened 45-day cycle.
Challenges: The elimination of the Equivalence Agreement pathways poses a critical challenge for manufacturers that have historically relied on U.S., Canadian, or Japanese approvals for expedited entry into the Mexican market. These companies will now face an increased regulatory burden, as they must prepare and submit a complete registration dossier according to Mexican requirements—likely resulting in longer preparation times and higher costs—unless they choose to pursue the new Abbreviated Regulatory Pathway.
Strategic Adaptation: Businesses must immediately reassess their regulatory pipeline for Mexico. Products that were planned for submission via an equivalence route will need to be redirected either through the standard registration process or the Abbreviated Regulatory Pathway.
Written By:
Tania Ramírez
Israel Jiménez
About ips
Our Regulatory Affairs team helps medical device manufacturers successfully obtain the sanitary licenses required to commercialize their products in Mexico. With in-depth knowledge of the local regulatory framework and a proven track record, we deliver tailored solutions that ensure compliance and reduce time-to-market.
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