Mexico - PROY-NOM-137-SSA1-2024 Draft Standard on the Labelling of Medical Devices

​The recently published draft Mexican Official Standard PROY-NOM-137-SSA1-2024, establishes the requirements governing the health information that must be contained in the labelling of medical devices for human use that are intended for users in, and are to be marketed and made available throughout, Mexican territory, for the correct use and traceability of the devices.

Once approved, the draft Mexican Official Standard shall become mandatory, throughout Mexican territory for establishments involved in the manufacture, packaging, distribution and import of medical devices to be marketed or supplied in Mexico.

The notified draft Mexican Official Standard PROY-NOM-137-SSA1-2024 stipulates that medical devices must include visible labelling containing health information relating to the identification of the medical device, the identity of the manufacturer, the technical description, the intended purpose, the correct use or intended use, how the device must be  maintained and stored, and any residual risk, warning, limitation or contraindication required to support and assist users of the medical device, to ensure its safe and appropriate use.