On May 19, 2026, Mexico has published NOM-137-SSA1-2025, a major overhaul of its medical device labeling standard that introduces stricter traceability requirements, expanded use of international symbols, and stronger sterility labeling expectations. Foreign manufacturers and importers will feel the greatest impact, with likely updates needed across labels, IFUs, and contra-labeling processes. With mandatory compliance kicking in on May 14, 2027, the roughly 360-day transition window makes now the right time to start your gap assessment.
It introduces several significant updates, including the requirement to include on the labeling the device’s intended use, manufacturing date, catalog or model number, an indication of whether the device is for single use and instructions on how to proceed in the event of adverse incidents.
The first point of the general requirements was revised to remove the reference to advertisement, narrowing the scope of the NOM to labels, and secondary labels within the primary, secondary and collective packaging.
The integrity of the label material is also addressed as a regulated topic depending on the medical device’s nature, and there is leeway to employ more symbols than those included under Appendix A, as long as their meaning is obvious. Otherwise, additional precautions will need to be in place to confirm its description is legible. This published version highlights that instructions for use intended for the general population must be clear, easy to understand and readily interpretable to support the device being used safely and that it performs as intended.
The IFU must now include device limitations, precautions concerning the presence of potentially carcinogenic, mutagenic, or toxic materials, rather than placing this information on the labeling, as previously required in the draft.
Unlike the above point, the expected lifetime of the device is expected to be included on the labels, while the draft requested this information on the IFU.
The scope of the registration holder’s responsibilities is broadened to include shared accountability with the manufacturer, particularly in defining the intended use on the labeling, as well as participation in the development and revision of the IFU.
Please refer to link below.
https://dof.gob.mx/nota_detalle.php?codigo=5787790&fecha=19/05/2026#gsc.tab=0
DOF - Diario Oficial de la Federación
DOF: 19/05/2026 NORMA Oficial Mexicana NOM-137-SSA1-2025, Etiquetado de dispositivos médicos NORMA Oficial Mexicana NOM-137-SSA1-2025, Etiquetado de dispositivos médicos. Al margen un sello con el Escudo Nacional, que dice: Estados Unidos Mexicano
dof.gob.mx
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