Accepted for/Published in: JMIR AI
Date Submitted: Mar 1, 2023
Open Peer Review Period: Feb 28, 2023 - Apr 25, 2023
Date Accepted: Jun 16, 2024
(closed for review but you can still tweet)
China’s Artificial Intelligence Development Plan: What are Implications and Challenges for Global Software Medical Device Manufacturers
ABSTRACT
The China State Council published The New Generation Artificial Intelligence (AI) Development Plan, which unveiled China’s initiative to be the world leader in AI by 2030. China declared that the application domains for AI were wide ranging, and they included manufacturing, law and medicine. China has already become a major producer and consumer of medical devices, with a growing number of software registrations. The large amount of software developed for healthcare within China has increased the need for further regulatory guidance for global manufacturers. This work presents an overview of the Chinese regulatory framework for medical device software, including software-as-a-medical-device and software-in-a-medical-device. The Chinese regulations for medical devices with AI and Machine Learning are compared to those in the United States and the Europe. This paper provides a useful outline of the current state of regulations for medical software in China, as well as the regulatory challenges they pose.
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Copyright
© The authors. All rights reserved. This is a privileged document currently under peer-review/community review (or an accepted/rejected manuscript). Authors have provided JMIR Publications with an exclusive license to publish this preprint on it's website for review and ahead-of-print citation purposes only. While the final peer-reviewed paper may be licensed under a cc-by license on publication, at this stage authors and publisher expressively prohibit redistribution of this draft paper other than for review purposes.