COFEPRIS has published a new agreement recognizing the evaluations and approvals from key international regulatory authorities and the WHO Prequalification Program for sanitary registrations of medicines and medical devices. This move, effective 60 business days after publication, aims to expedite access to medical devices by adopting a "reliance" approach, simplifying import procedures for essential products during health crises.
UPDATE
The Mexican Ministry of Health, through COFEPRIS, has issued a significant agreement published in the Official Gazette of the Federation (DOF) on June 11, 2025. This new regulation, which will take effect 60 business days after its publication, establishes a framework for recognizing the evaluations and approvals of various international Reference Regulatory Authorities (RRAs), as well as the World Health Organization (WHO) Prequalification Programme, for the sanitary registration of health products (medicines and medical devices) in Mexico. This initiative represents a strategic step toward streamlining regulatory processes and accelerating access to safe, effective, and high-quality of medical devices.
The agreement underscores the principle of “reliance,” whereby COFEPRIS will now consider and place significant weight on the regulatory decisions of trusted international authorities. This includes key agencies that are founding or permanent members of the International Council for Harmonisation (ICH), WHO Listed Authorities (WLAs), and Regional Reference National Regulatory Authorities (ARNr) for medicines. For medical devices, COFEPRIS will recognize authorities that are members of the International Medical Device Regulators Forum (IMDRF) Management Committee and the Medical Device Single Audit Program (MDSAP) for Good Manufacturing Practices (GMP) certification. This reliance-based approach seeks to optimize regulatory resources and improve the efficiency of the registration process.
A key component of this agreement is the introduction of abbreviated regulatory pathways for products that recognized RRAs have already authorized. While COFEPRIS retains exclusive authority to grant sanitary registrations, the reliance mechanism is expected to significantly shorten review timelines. For medicines, COFEPRIS has committed to a maximum resolution period of 60 business days, and for medical devices, 30 business days. This streamlined process represents a significant improvement for applicants seeking to bring their products to the Mexican market.
Furthermore, the agreement establishes specific criteria for the importation of medicines and medical devices intended to address emerging or neglected diseases, as well as national health emergencies. These critical health products, when procured through mechanisms such as the PAHO Strategic Fund, the PAHO Revolving Fund, or other mechanisms designated by the Ministry of Health, will be exempt from the requirement to obtain a sanitary registration in Mexico. This exemption is designed to accelerate the availability of essential products during public health crises.
This agreement also explicitly repeals previous provisions related to the recognition of foreign regulatory approvals, including those published on January 28, 2020; March 29, 2019; and June 22, 2021, among others. By consolidating these into a single, comprehensive framework, the agreement provides clearer guidance and reinforces COFEPRIS's commitment to aligning with international best practices in regulatory reliance, ultimately strengthening public health protection in Mexico.
REGULATORY FRAMEWORK
This RA Update primarily concerns and takes into account the following Mexican regulatory instruments:
General Health Law: Articles 3 (fractions IX, XXII, XXIII), 4 (fraction III), 13 (A, fraction II), 17 bis (fractions IV and VI), 194 (last paragraph), 194 Bis, 204, 222, 262, and 376. These articles establish the Ministry of Health's authority over sanitary control, particularly for medical devices and their import/export, and the requirement for sanitary authorizations.
Regulation of Health Supplies: Articles 2 (fractions XIII Bis 1, XIII Bis 2, XIV and XV), 161 Bis, 166, 167, 170, 177, 177 Bis 1 (fraction II), 177 Bis 2, 179, and 180. These articles detail specific requirements for health supplies, including quality, safety, and efficacy, and mechanisms for recognizing foreign regulatory requirements.
Organic Law of the Federal Public Administration: Article 39 (fractions XIII and XXI).
General Law of Regulatory Improvement: Article 84 (fractions I, II and IV).
Federal Law of Administrative Procedure: Articles 4 and 69-C.
Internal Regulation of the Ministry of Health: Article 7 (fraction XVII).
Official Mexican Standards: Applicable NOMs related to the stability of medicines and interchangeability studies for generic drugs.
ICH Guidelines (specifically M4): Referenced for the Common Technical Document (CTD) format for regulatory submissions.
Effects from RA Update
This new agreement is expected to generate significant operational and strategic impacts for pharmaceutical and medical device companies targeting the Mexican market:
Expedited Market Access: The most immediate impact is the potential for significantly faster sanitary registration approvals for medicines and medical devices that have already been authorized by recognized international reference authorities. This reduction in approval timelines shortens time-to-market, enabling companies to commercialize their products in Mexico more rapidly.
Reduced Regulatory Burden and Cost: By accepting evaluations from recognized RRAs, companies may benefit from a reduced need to submit redundant studies or documentation, thereby lowering the overall cost and administrative burden associated with the registration process. This creates a more streamlined and attractive regulatory environment for market entry.
Increased Predictability: The clear designation of recognized RRAs and the implementation of abbreviated regulatory pathways enhance predictability and transparency within the Mexican regulatory landscape. This allows companies to more effectively plan their market entry and product launch strategies.
Strategic Sourcing Opportunities: For companies involved in supplying products for emerging or neglected diseases, or national health emergencies, the exemption from sanitary registration for products acquired through designated international mechanisms—such as PAHO’s Strategic and Revolving Funds—opens new opportunities for streamlined sourcing and agile supply chain operations in support of public health initiatives.
Adaptation to Global Standards: To fully benefit from this new reliance framework, companies must ensure that their product documentation and manufacturing processes conform to the ICH Common Technical Document (CTD) format and the specific requirements of the recognized RRAs. This may require internal process adjustments to meet international and Mexican expectations consistently.
Monitoring of Post-Approval Changes: Holders of sanitary registrations granted under this framework must closely monitor and report any post-approval changes made following the RRAs original authorization. Timely notification to COFEPRIS is essential to maintain compliance with national regulatory obligations and to avoid disruptions in market access.
Written By:
Israel Jiménez
About ips
Our regulatory affairs team helps medical device manufacturers obtain sanitary licenses to commercialize their products in Mexico. We have a deep understanding of the local regulatory framework and a proven track record of success.
We offer a wide range of services to meet your specific needs. Contact your service leader or email us at info@insumosparasalud.com to learn more.