IPSNEWS
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.
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.
Industry Trends 2026
Dive into the medical device, cosmetic, and dietary supplement industry trends. We offer a look at what to expect during 2026.
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.
Tariff Classification as a compliance tool
Tariff classification is, without a doubt, the most important step for any foreign trade operation. It represents the standard code that allows customs to unequivocally identify the merchandise and, based on it, apply the entire regulatory framework.
Keys to International Trade: EUR.1 and USMCA Certificates for Mexico
In foreign trade, competitiveness and operational efficiency largely depend on effective document management. Among the most important documents is the certificate of origin, which certifies the country where a product was manufactured and, in Mexico’s case, is essential for obtaining tariff reductions or exemptions under free trade agreements.
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 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.