Mexico - Home

In an effort to streamline the regulatory processes for health products, the Mexican government has introduced new guidelines on July 18, 2025 aimed at simplifying the registration of medical supplies and pharmaceuticals. The initiative, published in the Diario Oficial de la Federación (DOF), marks a significant step towards enhancing the efficiency and accessibility of healthcare products in Mexico.

The newly issued Lineamientos Generales (General Guidelines) establish an abbreviated regulatory pathway for health product registrations. This approach will recognize the equivalence of requirements, tests, and evaluation procedures set forth by international regulatory authorities, including the World Health Organization's (WHO) Prequalification Program. By doing so, Mexico aims to improve the speed of approving health products while maintaining rigorous safety and efficacy standards.

Key Features of the New Guidelines

The Lineamientos Generales focus on two main types of health products: medications and medical devices. The guidelines define procedures for recognizing approvals granted by other established authorities such as the U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), and WHO-recognized agencies.

1. Medication Registration: The new process will apply to various types of pharmaceuticals, including new molecules, generics, and biotechnological products. For these, the evaluation criteria and technical documentation will align with the standards of recognized international authorities, such as the FDA, EMA, and WHO.

2. Medical Devices: Similarly, medical devices will be eligible for expedited registration when certified by recognized authorities such as the International Medical Device Regulators Forum (IMDRF). The guidelines also establish that regulatory decisions made by these bodies can be used to approve medical devices for use in Mexico, simplifying the approval process significantly.

Streamlined Process to Boost Health Product Availability

David Kershenobich Stalnikowitz, Secretary of Health, emphasized that the new system aligns with global best practices and will help ensure that essential health products are available more quickly to the Mexican population. "This initiative not only reduces bureaucratic hurdles but also strengthens Mexico's regulatory framework, ensuring that only safe, effective, and high-quality products reach the market," Kershenobich stated.

Under the new guidelines, pharmaceutical companies and medical device manufacturers will not be required to submit duplicate documentation. The evaluation process will be considerably faster, with a 45-day maximum deadline for medications and 30 days for medical devices, subject to compliance with the new regulations.

Changes to Existing Frameworks

The guidelines supersede previous agreements and provisions that allowed for recognition of foreign regulatory approvals. These updates aim to further clarify the regulatory path for health products imported into Mexico. By recognizing the equivalence of foreign evaluations, the Mexican government hopes to enhance its reliance on international standards while maintaining stringent oversight to protect public health.

Implementation Timeline

The new regulations will come into effect 30 days after their official publication in the Diario Oficial de la Federación, expected to be in mid-August. As part of the implementation process, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) will ensure that no additional documentation is required from applicants beyond the established guidelines. This move is expected to significantly reduce the time and cost associated with bringing medical products to market in Mexico.

Transition and Future Implications

With these new guidelines, Mexico is positioning itself to further integrate into global health product markets, offering more streamlined access to international companies looking to distribute their products in the region. The measures align with Mexico's commitment to improving public health standards while reducing regulatory delays. For further details, you can consult the Agreement (in Spanish) here. 

In a sweeping move to enhance regulatory efficiency, the Mexican government has announced on the 11th of July 2025 new measures aimed at simplifying the processes associated with health-related permits and certifications. The action, formally published in the Diario Oficial de la Federación on July 11, 2025, outlines a comprehensive framework for the reduction of bureaucratic hurdles, with a focus on improving the speed and accessibility of health-related licensing, certification, and approval processes.

Key Highlights of the New Regulations

1. Simplification of Trams and Services:
   The agreement establishes a series of steps to reduce the administrative burden for businesses and health establishments. Among the most notable changes is the introduction of "immediate resolution" modalities for several previously complex processes, including the modification of sanitary registrations for medical devices and pesticides. This marks a shift towards more responsive and flexible service delivery by regulatory bodies.

2. Reduction of Processing Times:
   The new framework significantly reduces processing times for key regulatory procedures. For example, the time to process modifications to pesticide registration has been halved, from 30 days to just 15 days. These cuts are intended to accelerate approvals, facilitating faster market access for critical health and safety products.

3. Shift to Notification-Based Systems:
   In a progressive step towards modernizing regulatory oversight, the Mexican government is moving from authorization-based systems to a notification-based approach for many health-related activities. Companies will now only need to notify the authorities of certain activities, such as the operation of health facilities, rather than awaiting explicit approval. This change is expected to significantly cut down on waiting times and reduce administrative overhead.

4. Improved Regulatory Clarity and Transparency:
   The regulations also introduce clearer guidelines on what constitutes necessary documentation for various processes. This includes eliminating redundant paperwork and streamlining the approval procedures for health-related establishments. By simplifying the submission process, the government hopes to reduce the potential for errors and delays.

5. Boost for Economic Activity:
   The regulatory changes are designed not only to improve efficiency but also to stimulate economic growth by encouraging the rapid deployment of health and safety products. This move is particularly relevant in the wake of growing global demand for medical devices, pharmaceuticals, and related health products, which require quick and predictable regulatory processes.

6. Future Modifications and Monitoring:
   The new rules allow for continuous improvements, with the Commission for the Protection against Health Risks (COFEPRIS) empowered to introduce further adjustments as needed. This adaptive approach ensures that the regulations remain responsive to evolving health challenges and industry needs.

What This Means for Businesses and Health Institutions

With the introduction of these measures, businesses in the health sector, including pharmaceutical manufacturers, medical device producers, and health service providers, can expect faster turnaround times and clearer instructions for regulatory compliance. This reform reflects a broader commitment to regulatory modernization, aligning Mexico’s public health oversight with international best practices. These changes are set to take effect within the next few weeks, with the full implementation of immediate resolution procedures and online processing expected within 30 days for most sectors. For futher details, you can consult the Agreement (in Spanish) here.