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Mexico - PROY-NOM-241-SSA1-2024 Draft Standard on Good Manufacturing Practices for Medical Devices
Recently, draft Mexican Official Standard PROY-NOM-241-SSA1-2024 on Good manufacturing practices for medical devices, was published on the Mexican Official Journal.
The purpose of this draft standard is to establish the minimum requirements for the processes of design, development, manufacturing, storage and distribution of medical devices for human use, based on their level of risk; which are marketed and made available in national territory in order to ensure that they consistently meet the quality, safety and performance requirements for use by the final consumer or patient.
This draft standard, once approved, shall be mandatory throughout the country for all establishments engaged in the manufacture of medical devices, packaging warehouses, storage and distribution of medical devices for marketing or supply purposes in Mexico.
For details, please refer to the draft standard.
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Mexico - PROY-NOM-241-SSA1-2024 Draft Standard on Good manufacturing practices for medical devices