Mexico Expands Health Product Registration Process with New Guidelines

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.