Mexico: New regulation for medical devices

 

Mexico has published a draft Mexican Official Standard PROY-NOM-137-SSA1-2024 on the labelling of medical devices.

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.

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.

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.

The following existing standards, or those replacing them, should be consulted in order to correctly implement the notified draft Mexican Official Standard:

• Mexican Official Standard NOM-008-SCFI-2002, Sistema General de Unidades de Medida.
• Mexican Official Standard NOM-050-SCFI-2004, Información comercial – Etiquetado general de productos.
• Mexican Official Standard NOM-072-SSA1-2012, Etiquetado de medicamentos y de remedios herbolarios.
• Mexican Official Standard NOM-240-SSA1-2012, Instalación y operación de la tecnovigilancia.
• Mexican Official Standard NOM-241-SSA1-2021, Buenas prácticas de fabricación de dispositivos medicos.
• Pharmacopoeia of the United States of Mexico, Suplemento para dispositivos médicos 5.0
• Pharmacopoeia of the United States of Mexico, Suplemento para Establecimientos dedicados a la venta y suministro de medicamentos y demás Insumos para la Salud (Sixth edition).

To find out more about product compliance in Mexico, please contact the Product Compliance Institute directly.