DOF Publication 08/11/2025
The AGREEMENT establishes measures to reduce procedures and requirements in processes carried out before the Federal Commission for the Protection against Sanitary Risks (COFEPRIS), with the purpose of expediting the import, export, and control of medicines, medical devices, tobacco, food, supplements, raw materials, human cells, and tissues.
Main Simplification Actions
ARTICLE ONE. Elimination of physical requirements
Printed documents such as labels of origin, explanatory letters, sanitary licenses, operating notices, sanitary registrations, export invoices, among others, are eliminated.
Essential information will be captured directly in simplified online or physical forms.
ARTICLE TWO. Merger of procedures
More than 30 procedures are reduced and grouped into 9 unified procedures, with new homoclaves.
ARTICLES THREE AND FOUR. Update of requirements
Duplicated requirements already included in other official registries, as well as documents issued by COFEPRIS itself, are eliminated.
ARTICLE FIVE. Reduction of resolution times
Response times are shortened by between 2 and 10 business days in several procedures.
Regarding medicines and medical devices, here are some of the new homoclaves and merged procedures, as well as updated requirements and resolution times:
Table of New Homoclaves, Merged Procedures, Requirements, and Resolution Times
| NEW HOMOCLAVE | MERGED PROCEDURES | REQUIREMENTS | RESOLUTION TIME |
| COFEPRIS-01-009. Sanitary import permit for raw materials or medicines that are not or do not contain narcotics or psychotropics, with sanitary registration. | COFEPRIS-01-009-A COFEPRIS-01-009-B COFEPRIS-01-009-C | 1. Complete online form. 2. Proof of fee payment. | 38 days |
| COFEPRIS-01-014. Sanitary import permit for medical devices that are not or do not contain narcotics or psychotropics, with sanitary registration. | COFEPRIS-01-014-A COFEPRIS-01-014-B | 1. Complete online form. 2. Proof of fee payment. For the import of radiation sources (including reagents or diagnostic agents with radioactive isotopes), additionally submit: 3. Import permit for radiation sources issued by the National Commission on Nuclear Safety and Safeguards. For medical devices with sanitary registration, no additional requirements are needed. | 38 days |
| COFEPRIS-01-015. Sanitary import permit for medical devices that are not or do not contain narcotics or psychotropics, without sanitary registration. | COFEPRIS-01-015-A COFEPRIS-01-015-B COFEPRIS-01-015-C COFEPRIS-01-015-D COFEPRIS-01-015-E COFEPRIS-01-015-F COFEPRIS-01-015-G | 1. Complete online form. 2. Proof of fee payment, except for medical devices intended for personal use. For used equipment, additionally submit: 3. Invoice indicating the equipment is used. For devices imported for maquila, if the IMMEX number indicated in the form is not listed in the IMMEX Program Directory, submit authorization letter issued by the Ministry of Economy. For Class II and III medical devices for medical use, additionally submit: 3. Good manufacturing practices certificate issued by the health authority of the country of origin. 4. Certificate of free sale issued by the health authority of the country of origin. For devices intended for personal use, additionally submit: 3. Official ID. 4. In the case of products not for free sale, a valid medical prescription including professional license number, covering the product and quantity. For devices intended for donation, additionally submit: 3. Donation letter issued by the donor, signed and recently dated. For devices intended for human research and laboratory testing, no additional requirements are needed. | 9 days |
ARTICLES SIX, SEVEN, AND EIGHT. Modernization and digitization
Procedures will preferably be carried out through the Mexican Digital Foreign Trade Window (VUCEM).
The requirement to submit documents issued by COFEPRIS itself and simple copies is eliminated.
Transitional Provisions
The agreement will enter into force:
- 180 business days after its publication for procedures carried out through VUCEM.
- 30 business days for in-person procedures for the import of products, medicines, medical devices, or samples for personal use.
Ongoing applications will continue to be resolved in accordance with the regulations in force at the time of their submission.
📌 In conclusion: This agreement aims to digitize, streamline, and simplify sanitary import and export procedures, reducing times, costs, and documentary duplications, in line with the National Law for the Elimination of Bureaucratic Procedures and the National Development Plan 2025–2030.
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