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FEBRUARY 7, 2022


VOLUME XII, NUMBER 38


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NextPrev


ARTICLE BY

Alejandro Luna Fandiño
Gustavo A. Alcocer
Armando Arenas




OLIVARES

               


RELATED PRACTICES & JURISDICTIONS


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 * Biotech, Food, Drug
 * Global
 * Health Law & Managed Care

 * Mexico

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NEW GUIDELINES FOR GOOD MANUFACTURING PRACTICES CONCERNING MEDICAL DEVICES IN
MEXICO

Tuesday, January 18, 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. 

© 2005-2022 OLIVARES Y COMPAÑIA S.C.National Law Review, Volume XII, Number 18

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RELATED LEGAL HEADLINES

Mexico: The Supreme Court of Justice Authorized the Industrial Use of Cannabis.
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By
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--------------------------------------------------------------------------------

About this Author

Alejandro Luna Fandiño
Partner

Alejandro Luna has been alternately dubbed “an extraordinary litigator, active
at every level,” “responsive and insightful,” and “a knowledgeable IP
practitioner offering creative and cost-effective advice” by his peers,
according to IAM Patent 1000, while World Trademark Review’s WTR 1000 called him
“a reliable ally for any party in a dispute”. Since joining OLIVARES in 1996 and
being made partner in 2005, he has been instrumental to the firm’s IP
Litigation, Regulatory, and Administrative Litigation practices. He co-chairs
the Life Sciences & Pharmaceutical...

alejandro.luna@olivares.mx
+52 (55) 5322 3000
www.olivares.mx
Gustavo A. Alcocer

Partner

Gustavo Alcocer manages the Corporate and Commercial Law Group at OLIVARES,
advising domestic and foreign businesses and the owners of those businesses on
Mexican and cross-border corporate and commercial transactions. He serves as
outside general counsel in Mexico to many of his domestic and foreign clients,
and also represents emerging and middle-market companies, including closely-held
businesses from Mexico, the United States, Canada and Latin America. Mr.
Alcocer’s significant experience on domestic and cross-border transactions
allows for extensive connections with...

gustavo.alcocer@olivares.mx
+52 (55) 5322 3000
www.olivares.mx
Armando Arenas

Partner

Armando Arenas joined OLIVARES in 2000 and became a partner in January 2017. He
has experience working on a range of IP matters, including consulting and
litigation on trademark, patent, unfair competition, trade dress protection, and
misleading advertising cases before the Mexican Institute of Industrial Property
(IMPI), Federal Court of Tax and Administrative Affairs (FCTA), Federal Circuit
Courts (FCC) and the Supreme Court of Justice (SCJ) Regulatory Affairs and
Public Acquisitions. Mr. Arenas is especially adept in patent litigation and
protection under Mexico’s patent linkage system...

armando.arenas@olivares.mx
+52 (55) 5322 3000 Ext. 3906
www.olivares.mx



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