IPSNEWS
Why can't your goods be released? Common compliance errors delaying your foreign trade operation
Retentions and delays in Mexican customs when importing medical devices, cosmetics, and dietary supplements, as well as any other product regulated by COFEPRIS, usually arise from critical inconsistencies in compliance with Non-Tariff Regulations and Restrictions (RRNAs).
Sanitary Import Permit for Medical Devices without Sanitary Registration
The importation of medical devices without sanitary registration in Mexico is feasible, provided there is no commercial purpose, through sanitary permit COFEPRIS-01-015.
Launch of the Medical Device Sanitary Registration Viewer: A step towards information analysis and consultation.
On August 20, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) made the Medical Device Sanitary Registration Viewer available to the public and the industry. This digital public inquiry tool enables the search, verification, and analysis of both current and historical sanitary authorizations issued in the country.
New COFEPRIS Guide: Optimization and agility in the Sanitary Registration of Medical Devices
Seeking to unify current Equivalence Agreements and the Abbreviated Regulatory Pathway, the Federal Commission for Protection against Sanitary Risks (COFEPRIS) has published the Requirements Guide for the Sanitary Registration of Medical Devices.
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.