January 12, 2022
After more than 10 years, the official standard of good manufacturing practices concerning medical devices has been updated. On December 20, 2021, the new version of the Official Mexican Standard NOM-241-SSA1-2021, Good medical device manufacturing practices, was published in the Official Gazette.
In general terms, this new version of the standard clarifies the previous one since it focuses on giving a greater order to the specifications that must be considered in each of the stages of the life cycle of a medical device, i.e., in each step of the manufacturing chain until its distribution and marketing. In particular, the chapter on the “Quality Management System” is strengthened.
Among the modifications, it is important to highlight that the scope of the definition of a medical device is extended because of technological advances, now including “…any instrument, device, utensil, machine, software, implantable product or material, diagnostic agent, material, substance or similar product to be used, alone or in combination, directly or indirectly in human beings with any of the following purposes of use indicated in the document itself”.
The inclusion of the definitions of “software” as a medical device is of high relevance and solves the old loop in the regulation of software in connection with medical devices.
Likewise, reference is made to the use of digital media, including digital records and the use of electronic signatures. Simultaneously, following the changes and inclusions throughout the new standard, these are reflected in the inclusion of various terms to be compatible with the new figures.
We are surprised that despite the current needs of the industry and patients, and the accelerated pace of technological advancement within this field, it has been decided that the standard will come into force after 18 months of the publication in the Official Gazette last December. This standard will leave NOM-241-SSA1-2012 without effect, until it enters into force in June 2023. Meanwhile, OLIVARES is analyzing a detail of the changes and additions, as well as the eventual impact and effects of this standard, to inform and advise our clients.