RAUpdate Administrative modernization of COFEPRIS: Streamlining procedures
This RAUpdate details the administrative reform published on May 4, 2026, focused on the digitalization and operational efficiency of The Federal Commission for Protection against Sanitary Risks (COFEPRIS). The analysis covers the elimination of physical requirements, the consolidation of procedure codes (homoclaves) regarding advertising, and the acceleration of medical device procedures. It serves as a strategic tool for regulated entities to adjust their compliance processes to the new mandatory deadlines and digital formats.
Update
On May 4, 2026, the Ministry of Health published a comprehensive administrative reform intended to modernize the interaction between productive sectors and COFEPRIS. Signed by Secretary David Kershenobich Stalnikowitz, this Agreement seeks to eradicate information duplication, supported by the National Law for the Elimination of Bureaucratic Procedures. The central shift is the elimination of physical bureaucratic burdens, replacing them with the regulated entity's direct responsibility for the veracity of information submitted digitally.
Regulatory Framework
The regulatory transformation is articulated through various objectives, including the simplification of requirements and existing procedure codes (homoclaves).
1. Elimination of physical requirements in advertising
One of the most relevant modifications is the removal of the obligation to present physical documentation that was previously mandatory:
Operating License (Aviso de Funcionamiento): A physical copy is no longer required for the following:
Advertising notices for Professional, Technical, Auxiliary, and Specialty activities.
Notice of the person responsible for the advertising of cosmetic products (by brand).
Advertising permits for Food and Non-Alcoholic Beverages.
Product label: Submission is no longer required for the Advertising Permit for Food and Non-Alcoholic Beverages.
Supporting documentation: For the Advertising Notice for cosmetics (by brand).
Note: Although the physical submission of these documents is eliminated, the essential information they contain must still be included in the corresponding digital or physical forms.
2. Restructuring of homoclaves
The Agreement implements a strategic merger of procedures to simplify identification.
Advertising Notices: Codes COFEPRIS-02-002-A, C, and D are consolidated under a single scheme, COFEPRIS-02-002 "Advertising Notice", covering:
A. Professional, Technical, Auxiliary, and Specialty Activities.
B. Health Supplies (targeted at health professionals).
C. Cosmetic Products (by brand).
Advertising Permits: Procedure codes COFEPRIS-02-001 and COFEPRIS-02-001-C are unified into a single flow called COFEPRIS-02-001 "Advertising Permit", covering:
A. Products and Services.
B. Health Supplies.
C. Food and Non-alcoholic Beverages.
Incorporation into Lists: Modalities A, B, and C of code COFEPRIS-05-041 are merged. Any request for addition or modification will now be managed under a single code for:
A. Additives and processing aids for food, beverages, and dietary supplements.
B. Permitted or restricted ingredients for perfumery and beauty products.
C. Prohibited or permitted plants for teas, infusions, and edible vegetable oils.
3. Requirements for new merged procedures
Following these mergers, requirements have been synthesized to facilitate technical assessment:
For Advertising Notices: Form FF-COFEPRIS-13 (or digital form) and the advertising project are required. For professional activities, the project must indicate the document number accrediting the profession or specialty.
For Advertising Permits: In addition to the form and project, proof of rights payment and technical documentation supporting categorical claims made in the advertising must be presented.
For List incorporation: Entities must submit the corresponding form accompanied by technical and scientific information justifying the safety and use of the element to be incorporated.
4. Administrative modification in Medical Devices
The medical device sector benefits from a clearer path for updating registrations. The assignment of sanitary registration rights for medical devices is defined under the assessment modality (COFEPRIS-2022-022-003); it now only requires Form FF-COFEPRIS-15, proof of payment, and supporting documentation according to the specific modification type.
5. Reduction of timelines
The reform significantly shortens response times for various procedures:
Advertising: The resolution time for advertising permits for food and non-alcoholic beverages is reduced from 20 business days to 15 business days.
Medical Devices: Administrative modifications to sanitary registrations under the dictamination modality decrease from 22 business days to only 15 business days.
Effects from RAUpdate
To ensure an orderly transition, the Agreement sets the following conditions:
Effective date: The Agreement enters into force thirty business days after its publication (June 16, 2026).
Ongoing procedures: Applications submitted before the effective date will be resolved under the previous regulations.
Technological condition: The reduction in processing times will become effective once COFEPRIS's digital platforms and technological tools are fully operational.
Responsibility: By removing the requirement for physical delivery, the burden of compliance shifts to digital data management. Regulatory departments must strengthen internal verification processes, as the applicant is directly responsible for the veracity of information shared via digital forms. Any inconsistency or falsehood detected may be subject to sanctions by the authority.
Written By:
Mariel Antonio
Regulatory affairs specialist with extensive technical expertise in the sanitary authorization and surveillance of advertising in digital platforms and traditional media. She provides strategic guidance to dietary supplement, cosmetic, and medical device companies to ensure strict compliance with current regulations.
About IPS
At IPS, our technical team specializes in the integration of advertising dossiers and medical device registrations, ensuring that all submitted information complies with the new administrative simplification criteria. We support your company in regulatory compliance to mitigate risks and optimize processing timelines before the health authority.
Contact us at info@insumosparasalud.com for more information regarding our specialized services.