Mexico Streamlines Public Health and Safety Regulations to Boost Efficiency and Transparency

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.