Mexico:
New Guidelines For Good Manufacturing Practices Concerning Medical Devices In Mexico.
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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.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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