Mexico manufacturing practices related to medical devices

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After more than 10 years, the official standard of good manufacturing practice for medical devices has been updated. On December 20, 2021, the new version of the official Mexican standard NOM-241-SSA1-2021, Good Manufacturing Practice for Medical Devices, was published in the Official Gazette.

In general, this new version of the standard clarifies the previous one, as it focuses on giving greater order to the specifications to be considered at each stage of the life cycle of a medical device, that is, at each step of the production chain through to distribution and Marketing. In particular, the “Quality Management System” chapter will be strengthened.

Among the changes, it is worth noting that the scope of the definition of a medical device has been broadened as a result of technological advances and now includes “…any instrument, device, utensil, machine, software, implantable product or material, diagnostic device, material, substance or similar product which alone or in combination, is intended to be used directly or indirectly in humans for any of the following purposes identified in the document itself”.

The inclusion of the definitions of “software” as a medical device is of great relevance and dissolves the old control loop of software in connection with medical devices.

Reference is also made to the use of digital media including digital records and the use of electronic signatures. At the same time, following the changes and additions, these are reflected throughout the new standard in the inclusion of various terms to be compatible with the new numbers.

We are surprised that, despite the current needs of industry and patients and the accelerated technological advances in this area, it was decided that the standard will come into force 18 months after publication in the Official Journal last December. This standard leaves NOM-241-SSA1-2012 ineffective until it becomes effective in June 2023.

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