Life Sciences Horizons Brochure 2025 - Flipbook - Page 74
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2025 Horizons Life Sciences and Health Care
China ups AI regulatory oversight to drive innovation while ensuring control
China's regulatory landscape for AI is evolving rapidly,
reflecting the country's ambition to become a global
technology leader while ensuring robust oversight and
control to ensure that AI developments are in line with
national interests. Since 2021, China has introduced
several national regulations to govern AI technologies,
including measures to address deep synthesis
technologies, algorithmic recommendation
technologies, and generative AI technologies.
China has also implemented an algorithmic record-filing
mechanism, which requires deep synthesis, algorithmic
recommendation, and generative AI service providers to register
their AI algorithms with the Cyberspace Administration of China
through the Internet Information Service Algorithm Record-Filing
System. In June 2023 and May 2024, the General Office of the State
Council twice announced plans to draft a comprehensive Artificial
Intelligence Law in China.
Recognizing the potential of AI to revolutionize life sciences and
health care, the Chinese government has integrated substantial
support for innovation into its regulatory framework. This
includes funding for AI-driven medical research and development
and the establishment of an AI innovation center, as well as
initiatives to construct smart hospitals, and to promote the use of
AI in drug discovery, medical imaging, surgical robots, intelligent
diagnosis, treatment planning, and personalized medicine.
Similar to the U.S., one of the most developed areas of application
and regulation for AI in the life sciences space in China relates to
AI-enabled software as a medical device (SaMD) and AI-enabled
software as an integral component of a physical medical
device (SiMD). In June 2022, the National Medical Products
Administration (NMPA) issued the Guiding Principles for the
Registration Review of Artificial Intelligence Medical Devices
(“Guiding Principles”), which classifies AI software with less
mature algorithm applications used for auxiliary medical decision
as a Class III medical device; while AI software with mature
algorithm applications used for non-auxiliary medical decisions
is classified as a Class II medical device.
The Guiding Principles emphasize management of AI software
medical devices throughout their entire life cycle, including:
ensuring the quality and integrity of data used to train
AI algorithms;
developing robust and reliable AI algorithms;
conducting thorough testing to validate the performance of AI
algorithms; and,
managing updates to AI software to maintain compliance and
performance.
The NMPA’s approach to AI-enabled SaMD and SiMD may provide
a blueprint for future regulations in other areas.
Roy Zou
Partner
Beijing
Lu Zhou
Partner
Beijing
Jessie Xie
Counsel
Beijing
Band 1
Life Sciences in Japan and
Asia-Pacific in Chambers
Asia-Pacific, 2025
