Medical devicesMexico: Good manufacturing practices for medical devices

Mexico published technical regulations pertaining to Mexican Official Standard NOM-241-SSA1-2018: Good manufacturing practices for medical devices.

The purpose of this Standard is to establish the minimum requirements for the design, development, manufacturing, storage and distribution processes of medical devices, based on their level of risk; in order to ensure that they consistently meet the requirements of quality, safety and functionality to be used by the final consumer or patient.

This Standard is mandatory in the national territory, for all establishments dedicated to the manufacture of medical devices, packaging warehouses, storage and distribution of medical devices.

The draft deals with issues such as Classification of medical devices, Quality Management System, Quality Risk Management, Design and development, Facilities and equipment, Qualification and validation, Manufacturing Systems, Quality Control Laboratory, Release of finished product, Stability studies, Recall, Subcontracted activities, Final destination of waste, etc.