MX Mexiko
  • 11 - Medizintechnik

Medical devices

Proyecto de Norma Oficial Mexicana PROY-NOM-241-SSA1-2018, Buenas prácticas de fabricación de dispositivos médicos (Draft Mexican Official Standard PROY-NOM-241-SSA1-2018: Good manufacturing practices for medical devices) (70 pages, in Spanish)

This Standard is binding in Mexican territory on all establishments engaged in the manufacture of medical devices and warehouses which package, store and distribute medical devices. It sets forth minimum requirements for the design, development, manufacture, warehousing and distribution of medical devices, based on their level of risk.