聚焦中国的人工智能医疗设备的监管应对措施及审批状况
Regulatory responses and approval status of artificial intelligence medical devices with a focus on China.
作者信息
Liu Yuehua, Yu Wenjin, Dillon Tharam
机构信息
School of Computer Engineering and Science, Shanghai University, Shanghai, China.
United Imaging Healthcare, Institute for medical imaging technology in Shanghai Ruijin Hospital, Shanghai Jiaotong University, Shanghai, China.
出版信息
NPJ Digit Med. 2024 Sep 18;7(1):255. doi: 10.1038/s41746-024-01254-x.
This paper focuses on how regulatory bodies respond to artificial intelligence (AI)-enabled medical devices. To achieve this, we present a comparative overview of the United States (USA), European Union (EU), and China. Our search in the governmental database identified 59 AI medical devices approved in China as of July 2023. In comparison to the rules-based regulatory approach in China, the approaches in the USA and EU are more standards-oriented.
本文聚焦于监管机构如何应对人工智能驱动的医疗设备。为实现这一目标，我们对美国、欧盟和中国进行了比较概述。我们在政府数据库中的检索发现，截至2023年7月，中国已批准59款人工智能医疗设备。与中国基于规则的监管方法相比，美国和欧盟的方法更注重标准。
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