IPSNEWS
VUCEM: Things you should know about the foreign trade receipt system
The Mexican Foreign Trade Receipt System (VUCEM) is the platform that allows for the digitalization and coordination of many of the necessary procedures for importing goods into Mexico.
COFEPRIS adopts the MDSAP and NOM-241 equivalence
The publication in the Official Gazette of the Federation (DOF) refers to the Recognition of the Medical Device Single Audit Program (MDSAP) as equivalent to the Certificate of Good Manufacturing Practices (GMP), whose conformity assessment is based on NOM-241-SSA1-2025 Good Manufacturing Practices of Medical Devices.
Key considerations for Cosmetic and Dietary Supplement claims in Mexico
Mexican regulations establish fundamental principles governing claims for cosmetic products and dietary supplements. The main objective is to ensure that these products are safe, effective, and not misleading to consumers.
Big Changes at COFEPRIS! Mexico Simplifies Medical Device Registration and Advertising Notice
Mexico's regulatory authority, COFEPRIS, has introduced a landmark agreement to modernize its regulatory processes. For medical devices, multiple submission categories for new registrations and renewals are now consolidated into a single, unified procedure. This reform streamlines submissions and shortens review timelines considerably. Additionally, the agreement introduces updated requirements for advertising notices.
COFEPRIS Implements Agreement to Streamline Import and Export Permits
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).
COFEPRIS Enables Regulatory Reliance Through Abbreviated Pathway
On July 18, 2025, COFEPRIS published the Agreement outlining the General Guidelines for the application of the Abbreviated Regulatory Pathway for granting sanitary licenses for medical devices and drugs.
Unlocking Efficiency: COFEPRIS Modernizes Regulatory Framework
On July 11, 2025, COFEPRIS published a landmark Agreement in the Official Gazette of the Federation, marking a decisive step toward the nationwide simplification and modernization of sanitary procedures.
Keys to the Labeling of Dietary Supplements in Mexico
Dietary supplements are defined as products intended to increase or complement the total dietary intake, or to supply one or more of their components. COFEPRIS is the authority in Mexico responsible for regulating these products and for establishing the labeling requirements they must meet to be marketed in the country.
COFEPRIS Modernizes Medical Device Framework: What You Need to Know
On July 7, 2025, Mexico’s regulatory authority, COFEPRIS, issued a new decree that substantially revises the classification framework for medical devices, thereby formally repealing the agreements published in 2011 and 2014.
Simplification of Operating License and Modification Process for Products and Services
COFEPRIS has implemented a series of simplification and modernization measures aimed at streamlining procedures and reducing the regulatory burden for establishments. These actions are part of the federal government’s regulatory improvement policies. This update specifically applies to the Operating License.