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.
Dietary Supplement labeling: COFEPRIS compliance guide
This article details the technical and legal requirements that must be met by labels for dietary supplements marketed in Mexico. Its objective is to provide manufacturers, importers, and distributors with a clear roadmap to ensure their products present truthful information, avoiding omissions that compromise transparency toward the consumer. The correct implementation of these elements ensures that the product remains within the current sanitary legal framework before COFEPRIS.
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.
Storage and distribution of dietary supplements under NOM-251-SSA1-2009
In the dietary supplement industry, storage is not merely the safeguarding of merchandise; it is a vital link in the value chain that guarantees the safety and efficacy of the final product. For distribution companies in Mexico, compliance with NOM-251-SSA1-2009 is both a legal and ethical obligation.
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.
Ingredient regulatory framework for dietary supplements in Mexico: A compliance guide
This article details the legal and sanitary framework governing permitted and prohibited ingredients in the formulation of dietary supplements in Mexico. It addresses questions regarding the technical viability of formulas, limits on additives, vitamins, minerals, and botanical extracts to avoid sanctions, customs seizures, or product redesigns.
Frequent errors when applying for a Sanitary Import Permit before COFEPRIS through VUCEM
This article explains the most common mistakes when applying for a Sanitary Import Permit before Federal Commission for the Protection against Sanitary Risks (COFEPRIS) and how to prevent them. It is aimed at importers of regulated products and seeks to help them avoid warnings, rejections, and delays in their procedures.
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.
How to classify a product as a dietary supplement? (Case study)
The correct classification of a dietary supplement in Mexico is a step that can determine a product's commercial viability. Beyond the formulation, factors such as the method of consumption and intended use play a role, both of which are evaluated under the sanitary framework applied by the competent authority.