On July 11, 2025, the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) published a landmark Agreement in the Official Gazette of the Federation. This transformative measure, which will come into effect 20 business days after its publication for most sections and 30 business days for provisions concerning immediate resolution procedures and modalities, marks a decisive step toward the nationwide simplification and modernization of sanitary procedures. It reflects COFEPRIS’s ongoing efforts to streamline regulatory processes and reduce administrative burdens across the health sector.
Update
This regulatory move aims to reduce administrative burdens, accelerate processing times, and foster a more agile environment that balances public health protection and national economic development. Among the key enhancements is the simplification of homoclaves, notably those for modifications to sanitary registration conditions and rights transfers, which are now unified under COFEPRIS-2022-022-033. Additionally, procedures are now categorized into two main types: immediate resolution and dictamination. These changes are set to significantly benefit businesses and professionals operating in regulated sectors by streamlining their interactions with the health authority and promoting greater regulatory efficiency across the board.
Regulatory Framework
This Agreement is grounded in various legal frameworks, reaffirming the Mexican State’s commitment to regulatory improvement and the constitutional right to health protection. Its legal foundation is primarily supported by the following instruments:
Political Constitution of the United Mexican States – Specifically, Article 4, which establishes the right to health protection, and Article 25, which promotes the implementation of regulatory improvement policies.
General Law of Regulatory Improvement – Enables the simplification of administrative procedures through the issuance of general agreements.
General Health Law and the Internal Regulations of the Ministry of Health – Provide the legal and administrative basis for health-related procedures and institutional actions.
Effects from the RA update
A key aspect of this reform is the Immediate Resolution modality. This category primarily applies to administrative modifications in the sanitary registration of medical devices, covering a range of common updates such as:
Changes in the address of the holder and/or national distributor.
Changes or additions of authorized distributors within Mexico.
Modifications to secondary packaging material.
Changes in the foreign distributor's company name and address.
Inclusion of new foreign distributors.
Elimination of manufacturers, presentations, or distributors, and other similar administrative adjustments.
All administrative and technical modifications to Low-Risk Medical Device Sanitary Registrations, excluding Rights Transfers.
For processes like revocation requests for Sanitary Registrations and other authorizations, COFEPRIS is now implementing an immediate resolution process. This procedure converts into a direct report: the "Report of Cancellation of Sanitary Registration and other authorizations." COFEPRIS will simply acknowledge the regulated entity's activity, thus significantly simplifying and accelerating the offboarding of products or services.
The Agreement also significantly reduces resolution times for key administrative processes. Notably, administrative modifications to the sanitary registration of medical devices (modality B for rights transfers) will now be processed in just 15 business days, down from the previous 22, substantially accelerating these crucial procedures.
Furthermore, the Agreement eliminates physical submission for certain requirements, such as copies of sanitary registrations, instructions for use, and technical/scientific/legal justifications. Relevant information must still be provided via COFEPRIS's specified physical or online formats, streamlining the submission process.
Finally, the Agreement optimizes requirements for merged procedures, including significant improvements for administrative modifications to medical device sanitary registrations (under immediate resolution) and second/subsequent sanitary registration extensions. These updates simplify necessary documentation, streamlining the application process.
Written By:
Abigail López
About ips
The implementation of these new provisions may raise questions about their impact on your specific operations. To ensure compliance with the updated regulations and fully capitalize on the opportunities these simplifications offer, we encourage you to seek specialized guidance. At IPS, our team is ready to help you understand the regulatory changes, answer your questions, and support the effective implementation of these measures.
For expert support, contact us at info@insumosparasalud.com