IPSNEWS
Prórroga de la Manifestación de Valor Electrónica
El pasado 02 de junio de 2026, el Servicio de Administración Tributaria (SAT) dio a conocer la versión anticipada de la segunda resolución de modificaciones a las Reglas Generales de Comercio Exterior (RGCE) para el presente ejercicio. En dicha publicación, se establece formalmente la extensión del plazo de obligatoriedad para transmitir la Manifestación de Valor electrónica (MVe) hasta el 31 de julio de 2026.
RAUpdate: Prohibition of Erythrosine (Red 3 FD&C) in the Mexican Food Industry
The Mexican Ministry of Health (Secretaría de Salud) has issued an Agreement to eliminate the use of the coloring agent Erythrosine and its lakes (Red 3 FD&C) in food, beverages, and dietary supplements. This measure responds to a risk analysis that determined that the population's exposure exceeds internationally established safety limits.
RAUpdate New NOM-137-SSA1-2025: Requirements for Medical Device labeling in Mexico
On May 19, 2026, Mexico's Ministry of Health published the new NOM-137-SSA1-2025 in the Official Gazette of the Federation (DOF), which completely replaces the version in force since 2008.
RAUpdate Administrative modernization of COFEPRIS: Streamlining procedures
The administrative reform published on May 4, 2026, is focused on the digitalization and operational efficiency of The Federal Commission for Protection against Sanitary Risks (COFEPRIS). The analysis covers the elimination of physical requirements, the consolidation of procedure codes (homoclaves) regarding advertising, and the acceleration of medical device procedures.
RAUpdate Reform to the Regulations for Health Supplies (RIS): Validity extension for Medical Devices
The Federal Commission for Protection against Sanitary Risks (COFEPRIS), through the Official Gazette of the Federation (DOF), updated some articles of its Regulations for Health Supplies (RIS, its acronym in Spanish), which helps to improve and reduce processing times.
RAUpdate Prórroga para la Manifestación de Valor Electrónica en las Reglas Generales de Comercio Exterior
El pasado 30 de marzo de 2026, el Sistema de Administración Tributaria (SAT) publicó de manera anticipada la primera resolución de modificaciones a las Reglas Generales de Comercio Exterior del año, la cual oficializa una prórroga para la entrada en vigor de la Manifestación de Valor Electrónica (MVE) hasta el 31 de mayo de 2026.
RAUpdate: Creation of the CENAFyT and its impact on the health sector.
On March 9, 2026, COFEPRIS officially announced the creation of the National Center for Pharmacovigilance and Technovigilance (CENAFYT). This body emerges not as an isolated entity, but as the strategic evolution of the former National Pharmacovigilance Center (CNFV), following the legal modifications made to the General Health Law at the beginning of 2026.
COFEPRIS Electronic Notification: Digitalization and deadline optimization
The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has formalized the use of email as an official channel for notification and requirements. This mechanism aims to streamline response times, reduce backlogs, and provide legal certainty to regulated entities by allowing digital tracking of administrative procedures.
Reform of the General Health Law 2026: Modernization and strategic challenges for the Mexican health sector
The reform to the General Health Law published in the Official Gazette of the Federation (DOF) on January 15, 2026, marks a milestone in Mexican sanitary regulation. This update not only formalizes Digital Health and Telehealth but also strengthens post-market surveillance mechanisms and restructures the validity period of Sanitary Registrations.
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.