Since March of this year, the health authority has published a series of agreements in the Official Journal of the Federation aligned with the Mexico Plan presented by the Federal Government, which aims to boost the national industry. Specifically, for the pharmaceutical and medical device sectors, the actions focus on reducing bureaucratic obstacles and simplifying procedures before the Federal Commission for the Protection against Sanitary Risks (COFEPRIS).
The following table summarizes the published agreements:
| Publication Date | Scope | Effective Date |
|---|---|---|
| 27/03/2025 | Simplification: Notices of operation and sanitary officer (health supplies, among others) | 21/04/2025 |
| 28/04/2025 | Simplification: Export certificates and advertising permits | 21/05/2025 |
| 28/04/2025 | Simplification: Research protocols | 21/05/2025 |
| 04/07/2025 | Simplification: Notices of operation and sanitary officer (health services) | 15/08/2025 |
| 11/07/2025 | Simplification: Conversion of procedures (immediate resolution, technical review, etc.) | 08/08/2025 – 22/08/2025 |
| 18/07/2025 | Abbreviated regulatory pathway: medicines and medical devices | 01/09/2025 |
| 11/07/2025 | Simplification: Procedures through VUCEM | 24/09/2025 – 14/05/2026 |
| 22/08/2025 | Simplification: Registrations, modifications, renewals, among others | 07/10/2025 – 27/05/2026 |
It is important to highlight that these agreements establish new procedure codes (homoclaves) and merged procedure names, as well as new formats, which—based on what has been published—are already in force and must be used for related submissions. The following table summarizes the applicable changes to some of the impacted procedures:
| Homoclave | Procedure | Form | Replaces |
|---|---|---|---|
| Not applicable | Notice of Operation and of the Sanitary Officer for Health Supplies Establishments Modalities: A. Manufacturing Plant of Medical Devices or Herbal Remedies B. Warehouse for Storage and/or Distribution of Medical Devices, Herbal Remedies, Non-Controlled Medicines, or Raw Materials for Non-Controlled Medicines C. Medicine Distributor (as the Legal Representative in Mexico of a Foreign Company) D. Allopathic Pharmacy or Homeopathic Pharmacy (Without the Preparation of Pharmaceutical Specialties) or Drugstore E. Retail Sale of Medical Devices or Herbal Remedies | COFEPRIS-05-006-A COFEPRIS-05-006-B COFEPRIS-05-006-C COFEPRIS-05-006-D COFEPRIS-05-006-E | Not applicable |
| Not applicable | Notice of Modification or Withdrawal of the Notice of Operation and/or Sanitary Officer for Health Supplies Establishments Modalities: A. Manufacturing Plant of Medical Devices or Herbal Remedies B. Warehouse for Storage and/or Distribution of Medical Devices, Herbal Remedies, Non-Controlled Medicines, or Raw Materials for Non-Controlled Medicines C. Medicine Distributor (as the Legal Representative in Mexico of a Foreign Company) D. Allopathic Pharmacy or Homeopathic Pharmacy (Without the Preparation of Pharmaceutical Specialties) or Drugstore E. Retail Sale of Medical Devices or Herbal Remedies | COFEPRIS-05-007-A COFEPRIS-05-007-B COFEPRIS-05-007-C COFEPRIS-05-007-D COFEPRIS-05-007-E | Not applicable |
| COFEPRIS-04-030 | Sanitary Registration of Medicines | FF-COFEPRIS-22 | COFEPRIS-04-004-A to H, COFEPRIS-04-006-A to B, COFEPRIS-04-007-A to B, COFEPRIS-04-008-A to B |
| COFEPRIS-04-040 | Application for Sanitary Registration of Medicines by Equivalence from Reference Regulatory Authorities | FF-COFEPRIS-01 | COFEPRIS-04-004-I to K |
| COFEPRIS-04-050 | Application for Sanitary Registration of Medical Devices by Equivalence from Reference Regulatory Authorities | FF-COFEPRIS-01 | COFEPRIS-04-001-D to H |
| COFEPRIS-04-060 | Sanitary Registration of Medical Devices | FF-COFEPRIS-21 | COFEPRIS-04-001-A to C |
| COFEPRIS-04-070 | Sanitary Registration of Low-Risk Medical Devices | FF-COFEPRIS-21 | COFEPRIS-04-001-I to K |
| COFEPRIS-04-080 | Renewal of the Sanitary Registration of Medicines | FF-COFEPRIS-22 | COFEPRIS-2022-022-007-A to 010-A |
| COFEPRIS-04-090 | Renewal of the Sanitary Registration of Medical Devices | FF-COFEPRIS-21 | COFEPRIS-2022-022-001-A to 002-A |
| COFEPRIS-2022-022-003 | Administrative Modification of the Sanitary Registration of Medical Devices Modalities: A. Immediate Resolution B. Evaluation Required | FF-COFEPRIS-15 | COFEPRIS-2022-022-003-A COFEPRIS-2022-022-005-A |
| COFEPRIS-2022-022-004-A | Technical Modification with Evaluation to the Conditions of the Sanitary Registration of Medical Devices | FF-COFEPRIS-15 | Not applicable |
| COFEPRIS-2022-022-012-A | Certificate of Moderate Modification to the Conditions of the Sanitary Registration of Medicines | FF-COFEPRIS-15 | Not applicable |
| COFEPRIS-2022-022-013-A | Major Modifications to the Conditions of the Sanitary Registration of Medicines | FF-COFEPRIS-15 | Not applicable |
| COFEPRIS-10-001 | Transfer of Rights of the Sanitary Registration of Medicines | FF-COFEPRIS-15 | Not applicable |
Finally, it is relevant to mention that these changes are not yet fully implemented, as the COFEPRIS systems and digital platforms still lack the necessary updates for the launch of the new procedure codes, and most of the formats listed above have not yet been officially published.
In conclusion, the recent regulatory updates published by the health authority represent a significant step toward modernizing and improving efficiency in Mexico’s regulatory framework, particularly for the pharmaceutical and medical device industries. These measures, aligned with the Mexico Plan, aim to reduce bureaucratic burden through simplified procedures, standardized formats, new homoclaves, and an abbreviated regulatory pathway.
However, despite the regulatory efforts, practical implementation remains a challenge, as many of the required systems and platforms have not yet been updated. To ensure the intended impact, it will be essential for COFEPRIS to expedite technological adaptation and ensure the publication and operability of the new formats and processes.
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