IPSNEWS
RAUpdate Primera Resolución de modificaciones a las RGCE para 2026: Prórroga de la MVE y precisiones técnicas
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.
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.
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.