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. This standard establishes the minimum criteria for mandatory sanitary information and traceability for all medical devices commercialized in national territory, leading companies in the sector to restructure their packaging strategies, implement risk management in their labels, and adopt digital tools within strictly defined deadlines.
Update
In addition to obligatorily regulating all establishments dedicated to the manufacturing, conditioning, distribution, or importation of medical devices in Mexico, the NOM-137-SSA1-2025 aims to establish the traceability of medical device sanitary information for the correct use of said devices.
The standard will enter into force 360 calendar days after its publication (mid-May 2027), subsequently granting a transitional period of 180 calendar days to exhaust existing stocks of packaging materials and finished products that cannot be modified immediately.
Among the most disruptive changes is the formal authorization of electronic labeling. Manufacturers may supplement, but not substitute, the mandatory physical information by using technologies such as QR codes, barcodes, or radio frequency identification (RFID), redirecting users to web platforms to consult detailed manuals or instructions. Likewise, specific labeling rules for Software as a Medical Device (SCDM or SaMD) are introduced for the first time, requiring that the version identifier or release date be easily accessible on the digital interface.
For imported products that do not comply with the entirety of the standard from their origin, the counter-label requirement is maintained. Supplementary information in Spanish may be incorporated in Mexican territory after customs clearance, but obligatorily before its commercialization or supply to the public. Finally, the design of any label must now be supported by a documented risk management process from the manufacturer.
The catalog of symbols in Appendix A (Normative) is harmonized and expanded to 70 regulatory symbols and safety tables that standardize legends such as expiration dates, storage conditions, and critical material warnings (e.g., presence of latex or hazardous substances). Additionally, the symbols are categorized according to the information they provide and which could contribute to post-market surveillance.
For information traceability, the standard details specifications that must be contained in manuals or instructions for use. In the case of diagnostic agents, it mentions that they must indicate information that functions as intended, such as the traceability of the values assigned to calibrators and the materials used to verify calibration.
REGULATORY FRAMEWORK
The application and compliance of the new NOM-137-SSA1-2025 are based on the following legal instruments:
Ley General de Salud (LGS): Based on articles 194, 194 bis, 195, 210, 212, 214, and 262 to 266, which govern the sanitary control of supplies and their authorizations.
Reglamento de Insumos para la Salud (RIS): Articles 11, 24, 165, 179, 182, and 183, relating to the requirements for supply labels and the submission of information in Spanish.
Complementary Operating Standards: Direct linkage with NOM-241-SSA1-2025 (Good Manufacturing Practices) and NOM-240-SSA1-2012 (Installation and operation of technovigilance).
EFFECTS FROM RAUPDATE
Impact on Sanitary Registrations:
All information contained in the commercial labels must be in total concordance with the Sanitary Registration Document issued by the Federal Commission for the Protection against Sanitary Risks (COFEPRIS).
Any omission or addition of non-evident symbols or those outside the standard will require technical support in the dossier and, potentially, the submission of a modification to the sanitary registration conditions.
Impact on supply chain / importation:
Foreign manufacturers and importers must review their packaging lines or plan conditioning units in Mexico for the correct post-customs application of counter-labels.
Inventory transition must be strictly scheduled under the 180-day grace period subsequent to the entry into force to avoid commercial retentions or operational fines.
Multiple or collective packages now have a strict obligation to declare the net content based on their authorized generic name.
Impact on Quality Systems and Post-Market Surveillance:
The Quality Management Systems (QMS) of holders in Mexico must include strict control of labeling project versions.
It is mandatory to incorporate clear contact information and guidance on the labeling so that the user or health professional can report Adverse Incidents (AI) to the authority, directly linking the packaging with the company's internal Post-Market Surveillance unit.
Written By:
Israel Jiménez
Regulatory Affairs Coordinator with 10 years of experience specializing in the medical device sector. A former COFEPRIS-certified reviewer, they currently coordinate regulatory operations and design compliance strategies for healthcare companies. Their approach balances technical rigor with strategic support to ensure client success in highly regulated environments.
About IPS
At IPS, we specialize in guiding the medical device industry through regulatory compliance. Our expert team is focused on facilitating the transition toward intelligent labeling systems and Software as a Medical Device (SaMD) under the guidelines of the new NOM-137-SSA1-2025. Our mission is to simplify regulatory complexity to accelerate the market entry of health technologies in Mexico.
Contact us: info@insumosparasalud.com