DOF Publication 08/22/2025
The AGREEMENT establishes measures to optimize procedures related to Sanitary Registrations (RS) of medicines, medical devices, herbal remedies, supplements, and other health supplies, as well as their renewals and modifications.
Main Simplification Actions
ARTICLE ONE. Merger and reduction of procedures
Duplications are eliminated, and more than 50 procedures are reduced to a smaller number through unified procedures with new codes (homoclaves).
Example: different types of RS renewals are consolidated into a single procedure; the same applies to minor and major modifications.
ARTICLE TWO. Standardization of requirements
Reduction of requirements: online form, payment of fees, safety/efficacy studies, certificates of free sale, or good manufacturing practices (when applicable).
Submission of documents already available in previous files or official databases is eliminated.
ARTICLE THREE. Simplification of requirements
The designation and requirements to be submitted for the procedures listed in the AGREEMENT are updated.
ARTICLE FOUR. Merger of homoclaves for issuance of Certificates for Export Support.
ARTICLE FIVE. The resolution times of the procedures listed in the AGREEMENT are reduced.
ARTICLE SIX. The homoclaves corresponding to procedures for applications of sanitary registrations of medicines and medical devices through equivalency agreements are eliminated, in accordance with the AGREEMENT published on 07/18/2025.
ARTICLES SEVEN, EIGHT, AND NINE. Modernization and digitization
The requirement to submit documents issued by COFEPRIS itself and simple copies is eliminated.
Use of new forms that will be published on the official COFEPRIS portal.
Regarding medicines and medical devices, here are some of the new homoclaves and merged procedures, as well as resolution times:
Table of New Homoclaves, Merged Procedures, and Resolution Times
| NEW HOMOCLAVE | MERGED PROCEDURES AND NEW FORM | RESOLUTION TIME |
| COFEPRIS-04-060. Sanitary registration of medical devices. | COFEPRIS-04-001-A COFEPRIS-04-001-B COFEPRIS-04-001-C Form FF-COFEPRIS-21 | Class I: 20 business days Class II: 25 business days Class III: 35 business days |
| COFEPRIS-04-070. Sanitary registration of medical devices considered low risk. | COFEPRIS-04-001-I COFEPRIS-04-001-J COFEPRIS-04-001-K Form FF-COFEPRIS-21 | 15 business days |
| COFEPRIS-04-090. Renewal of sanitary registration of medical devices. | COFEPRIS-2022-022-001-A COFEPRIS-2022-022-002-A Form FF-COFEPRIS-21 | 45 calendar days |
| COFEPRIS-04-030. Sanitary registration of medicines. | COFEPRIS-04-004-A COFEPRIS-04-004-B COFEPRIS-04-004-C COFEPRIS-04-004-D COFEPRIS-04-004-E COFEPRIS-04-004-F COFEPRIS-04-004-G COFEPRIS-04-004-H COFEPRIS-04-006-A COFEPRIS-04-006-B COFEPRIS-04-007-A COFEPRIS-04-007-B COFEPRIS-04-008-A COFEPRIS-04-008-B Form FF-COFEPRIS-22 | New molecule: 120 calendar days Generics, biocomparables: 90 calendar days Herbal, homeopathic, and vitamin-based: 25 business days |
| COFEPRIS-04-080. Renewal of sanitary registration of medicines. | COFEPRIS-2022-022-007-A COFEPRIS-2022-022-008-A COFEPRIS-2022-022-009-A COFEPRIS-2022-022-010-A Form FF-COFEPRIS-22 | 45 calendar days |
| COFEPRIS-2022-022-004-A. Technical modification with assessment to the conditions of the sanitary registration of medical devices. | Not applicable. Form FF-COFEPRIS-15 | 11 business days |
| COFEPRIS-2022-022-012-A. Certificate of moderate modification to the conditions of the sanitary registration of medicines. | Not applicable. Form FF-COFEPRIS-15 | Not applicable |
| COFEPRIS-2022-022-013-A. Major modifications to the conditions of the sanitary registration of medicines. | Not applicable. Form FF-COFEPRIS-15 | 25 business days |
| COFEPRIS-10-001. Transfer of rights of the sanitary registration of medicines. | Not applicable. Form FF-COFEPRIS-15 | 10 business days |
TRANSITIONAL PROVISIONS
The agreement enters into force 30 business days after its publication.
For procedures related to major modifications of medicines, renewals, and advertising notices, as well as the reduction of response times indicated in ARTICLE FIVE, the agreement will enter into force 180 business days after its publication.
Applications already submitted will continue to be resolved in accordance with the regulations in force at the time of their filing.
In conclusion: This agreement seeks to simplify, digitize, and expedite procedures for sanitary registrations, renewals, and modifications, reducing duplications, costs, and resolution times, in line with the policy of eliminating bureaucratic procedures and the National Development Plan 2025-2030.
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