Regulatory responses and approval status of artificial intelligence medical devices with a focus on China

被引：0

作者：

Liu, Yuehua ^{[1
]}

Yu, Wenjin ^{[2
]}

Dillon, Tharam ^{[3
]}

机构：

[1] Shanghai Univ, Sch Comp Engn & Sci, Shanghai, Peoples R China

[2] Shanghai Jiao Tong Univ, United Imaging Healthcare, Inst Med Imaging Technol, Shanghai Ruijin Hosp, Shanghai, Peoples R China

[3] La Trobe Univ, Dept Comp Sci & Informat Technol, Melbourne, Australia

来源：

NPJ DIGITAL MEDICINE | 2024年 / 7卷 / 01期

关键词：

D O I：

10.1038/s41746-024-01254-x

中图分类号：

R19 [保健组织与事业（卫生事业管理）];

学科分类号：

摘要：

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.

引用

页数：11

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