Accelerating Market Access in Mexico: Understanding COFEPRIS’s New Abridged Regulatory Pathway
The regulatory landscape for the entry of medical devices into Mexico has just undergone a significant transformation. On July 18, 2025, the “Acuerdo por el que se emiten los Lineamientos generales para la aplicación de la vía regulatoria abreviada para el otorgamiento de los registros sanitarios de insumos para la salud” (Agreement issuing the general guidelines for the application of the abridged regulatory pathway for granting sanitary registrations for health supplies) was published in the Official Gazette of the Federation. This document establishes a new abridged regulatory pathway for obtaining sanitary registrations, representing a crucial step forward for companies seeking agility and efficiency in the authorization process.
The main objective of this new regulation is to allow the Federal Commission for the Protection against Health Risks (COFEPRIS) to recognize evaluations, tests, and requirements already approved by other reference regulatory authorities (RRAs) and by the World Health Organization (WHO) prequalification program.
This mechanism is based on the principle of “Reliance,” a global concept of Good Regulatory Practices recommended by the WHO. Reliance is the act of a regulatory authority considering and giving weight to evaluations conducted by another trusted authority to make its own decisions. By means of these new guidelines, COFEPRIS optimizes its resources and increases efficiency, avoiding the duplication of evaluation processes that have already been carried out by renowned agencies abroad.
The abridged pathway does not compromise the safety, quality, or efficacy of the products. COFEPRIS ensures that the health supply is identical to the one approved by the RRA, with the same essential quality characteristics and components. The RRA approval must have been issued no more than five years ago.
What changes for companies?
The new procedure applies to a wide range of products, including medicines such as generics, new molecules, innovative biotechnological products, biosimilars, biological products, and vaccines. Medical devices are also included.
The document also specifies which are the Reference Regulatory Authorities (RRAs) recognized by COFEPRIS. For medicines, these include the founding members or permanent regulators of the ICH (International Council for Harmonisation), such as the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA). For medical devices, COFEPRIS recognizes the decisions of the member countries of the International Medical Device Regulators Forum (IMDRF) Management Committee and the Medical Device Single Audit Program (MDSAP).
One of the biggest advantages is the resolution timeframe. With the new guidelines, COFEPRIS will have a maximum of 45 business days to issue a sanitary registration resolution for medicines and 30 business days for medical devices. This represents a huge reduction in waiting time, which can be a crucial competitive differentiator.
Navigating the complex regulatory environment in Mexico requires knowledge and experience. With a deep understanding of the new regulations and COFEPRIS’s requirements, Passarini Group can help your company take advantage of this opportunity.
Our team is ready to guide you through every step of the process, from preparing the necessary documentation to submitting and following up on your sanitary registration application. Avoid delays and ensure your entry into the Mexican market is a success by following the new abridged regulatory pathway.
Contact our experts and find out how we can accelerate your sanitary registration in Mexico. Send an email to contato@passarini.com.br
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