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

Proyecto de Norma Oficial Mexicana PROY-NOM-137-SSA1-2024, Etiquetado de dispositivos médicos (draft Mexican Official Standard PROY-NOM-137-SSA1-2024 on the labelling of medical devices) (24 pages, in Spanish)

·        Purpose

The notified draft Mexican Official Standard 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.

·        Scope

The notified draft Mexican Official Standard is mandatory throughout Mexican territory for establishments involved in the manufacture, packaging, distribution and import of medical devices to be marketed or supplied in Mexico. Medical devices are crucial for the prevention, diagnosis and treatment of illnesses, as well as for patient rehabilitation. 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.