On August 11, 2025, the Agreement establishing actions for the simplification of procedures before the Federal Commission for the Protection against Sanitary Risks (COFEPRIS) was published in the Official Gazette of the Federation (DOF). This measure aims to optimize the import and export permits processes for health supplies, medicines, medical devices, dietary supplements, and other products by eliminating physical requirements, unifying procedures, and reducing response times.
Update
Elimination of Physical Requirements. The obligation to physically submit certain documents for the substantiation of procedures is eliminated. The information from these documents must be captured in the corresponding forms, either online or in physical format, as applicable. These documents include, for example, sanitary licenses, sanitary registrations, operating notices, and letters of justification.
Unification of Procedures. Multiple procedures are consolidated into a single one to streamline processes and eliminate duplication. Examples:
Modalities COFEPRIS-01-009-A, 01-009-B, and 01-009-C are unified into a single sanitary permit for the import of raw materials or medicines that do not contain narcotics or psychotropics and have a corresponding sanitary registration.
Modalities COFEPRIS-01-014-A and 01-014-B are unified in the Sanitary permit for the import of medical devices that are not or do not contain narcotics or psychotropics and that have a sanitary registration.
Modalities COFEPRIS-01-015-A to 01-015-G are unified in the Sanitary permit for the import of medical devices that do not contain or are not narcotics or psychotropics, and do not require sanitary registration.
The updated procedure codes (homoclaves) and requirements for the unification procedures are specified in the agreement.
Reduction in resolution times. The agreement shortens the resolution times for various procedures, improving predictability and efficiency in operations. Some examples:
COFEPRIS-01-002 (Sanitary permit for the import of products): from 5 to 4 business days.
COFEPRIS-01-014 (Permit for the import of medical devices with sanitary registration): from 40 to 38 business days.
COFEPRIS-01-016 (Sanitary permit for import by return – products): from 15 to 5 business days.
COFEPRIS-01-024 (Permit for the entry or exit of cells and tissues, blood and derivatives): from 45 to 35 business days.
Effective Dates. The agreement will apply:
Within 180 business days for procedures submitted through the Mexican Digital Foreign Trade Portal.
In 30 business days for in-person procedures related to the import of products, medicines, medical devices, or samples for personal use, as well as for public institutions that import health supplies for stock or risk prevention.
Regulatory Framework
This update is part of the compliance with the National Law for the Elimination of Bureaucratic Procedures, which aims to simplify administrative procedures and digitalize services. This agreement is based on:
General Health Law, in its provisions on the sanitary control of health supplies, medical devices, medicines, and other regulated products.
National Law for the Elimination of Bureaucratic Procedures, regarding the simplification and digitalization of procedures.
Applicable Regulations:
Regulations of the General Health Law regarding Health Supplies.
Regulations for Sanitary Control of Products and Services.
Regulations of the General Health Law regarding the Provision of Medical Care Services.
Relevant Official Mexican Standards, such as NOM-229-SSA1-2002 for ionizing radiation in medical diagnostics.
Effects from the RA update
The agreement promotes a transition towards more efficient and digital processes by eliminating the physical submission of various documents and unification procedures into fewer modalities. Furthermore, the reduction in resolution times strengthens companies’ planning capabilities and facilitates the timely availability of regulated supplies in the market, generating greater certainty in commercial and sanitary operations.
Written By:
Dulce Ángel
About ips
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