Mexico is undergoing a period of profound transformation. In recent months, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has initiated a substantial review of its medical device registration system. The objective is clear: to simplify and streamline market access procedures while increasing user safety.

This summer marked a turning point with a series of agreements designed to reshape regulatory processes in the Mexican market. This awaited revolution is well-received by manufacturers, given that Mexico, despite being a strategic market, has until now been hindered by long and complex authorization processes.

July 2025 Agreement: New Rules for Low-Risk Devices

An important step in this reform was the “Acuerdo de Dispositivos Médicos Julio 2025,” signed on July 6 and published on July 15 in the Diario Oficial de la Federación (the Mexican Official Gazette).

This document has fundamentally reformed the 2011 and 2014 regulations for low-risk Medical Devices, introducing a new structure based on three Annexes (Anexos):

• ANEXO UNO: lists low-risk devices with mandatory registration. For the first time, some previously exempt devices will now require registration. Manufacturers have a transition period with phased deadlines between 2025 and 2028, based on the product’s submission number.

• ANEXO DOS: lists low-risk devices exempt from registration. Although they do not require formal registration, these products must comply with specific obligations, including adherence to Good Manufacturing Practices (GMP), compliance with technovigilance standards, and the designation of a Mexico Authorized Representative (MRH).

• ANEXO TRES: lists products not considered Medical Devices, providing greater clarity on which products are completely exempt from COFEPRIS regulation.

It is crucial for manufacturers to verify the status of their products on the market as soon as possible to understand if a new registration is required or if documentation needs to be updated.

August 22, 2025 Agreement: Simplification and Unification

Subsequently, an Agreement aimed at substantially simplifying registration procedures was published on August 22, 2025.

Among the main changes:

• Consolidation of procedures: Registration procedures, previously differentiated by type (domestic manufacturing, importation, third-party manufacturing), have been merged into a single process.
• Reorganization of homoclaves: The agreement strengthens the use of unique alphanumeric codes (homoclaves) to identify each submission. Tables have been published that associate updated homoclaves with different device categories, such as COFEPRIS-04-070 for low-risk devices and COFEPRIS-04-060 for the ordinary pathway. This approach simplifies traceability and reduces redundancies.

It is important to note that, as of October 6, the old procedures based on equivalency with authorizations from bodies like the FDA and Health Canada will no longer be accepted.

This agreement does not override the previous July 18, 2025 agreement, which formalizes the abbreviated pathway based on the recognition of approvals from Reference Regulatory Authorities (RRA).

What This Means for Manufacturers

The direction taken by COFEPRIS is toward a more efficient, transparent, and predictable regulatory environment. For medical device manufacturers, it is essential to understand this new regulatory framework to adapt their registration strategy and ensure solid, long-term compliance in a market where further changes are expected.

Complife’s experts offer support to assess the impact of these changes and define the best regulatory strategy to obtain or maintain a presence in the Mexican medical device market.

SOURCES:

• https://www.dof.gob.mx/nota_detalle.php?codigo=5658607&fecha=15/07/2025
• https://www.gob.mx/cofepris/documentos/acuerdo-de-la-secretaria-de-salud-por-el-que-se-modifica-el-anexo-2-del-acuerdo-de-la-secretaria-de-salud-por-el-que-se-establecen-los-requisitos-de-tramites-y-procedimientos-para-la-obtencion-de-registros-sanitarios-de-dispositivos-medicos
• https://www.dof.gob.mx/nota_detalle.php?codigo=5661234&fecha=22/08/2025
• https://www.gob.mx/cofepris/documentos/acuerdo-por-el-que-se-establecen-las-homoclaves-y-procedimientos-para-la-obtencion-de-registros-sanitarios-y-demas-tramites-de-dispositivos-medicos