IPSNEWS
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.
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.
Revolutionizing Health Product Access in Mexico: COFEPRIS Embraces Global Regulatory Reliance
COFEPRIS has published a new agreement recognizing the evaluations and approvals from key international regulatory authorities and the WHO Prequalification Program for sanitary registrations of medicines and medical devices. This move, effective 60 business days after publication, aims to expedite access to quality health inputs by adopting a "reliance" approach, simplifying import procedures for essential products during health crises.