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This paper is in the following e-collection/theme issue:

AI Language Models in Health Care (753) Design and Usability of Medical Devices (232) Artificial Intelligence (4812) Development of Novel Medical Devices and Innovations for Existing Devices (155) Artificial Intelligence in Industry (46) Medical imaging (195)

Published on in Vol 14 (2026)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/85538, first published .
Doctor wearing headset and lab coat, looking at laptop in front of X-rays

Approval of AI-Based Medical Devices in China From 2020 to 2025: Retrospective Analysis

Approval of AI-Based Medical Devices in China From 2020 to 2025: Retrospective Analysis

Authors of this article:

Lingli Zhang1 Author Orcid Image ;   Jianzhou Yan1, 2 Author Orcid Image
Article Authors Cited by (4) Tweetations (2) Metrics

Journals

  1. Katterbauer K, Yılmaz S, Özbay R. AI-Enabled Drug Discovery Platforms: Navigating the Confluence of Software, Medical Device, and Pharmaceutical Regulation in Sino-African Trade Relations. Yildiz Social Science Review 2026;12(1):40 View
  2. Ali M, Tajwar M, Ahmed F, Hussain M, Wong W, Xiong H. Emerging Trends in Artificial Intelligence‐Driven Drug Discovery: Balancing Chemical Design and Pharmacological Properties for Cancer Therapy. Medicinal Research Reviews 2026 View
  3. Hu F, Yang H, Cheng J, Huang Z, Yang S, Wang X, Zhou H, Hu J, Hu H, Zhao S. Spatiotemporal evolution of innovation collaboration networks in China’s AI medical device industry: implications for public health governance. Frontiers in Public Health 2026;14 View
  4. Korabelnikov D, Lamotkin A. Comparative analysis of artificial intelligence-enabled medical devices in the state registries of the USA, China, and Russia. FARMAKOEKONOMIKA. Modern Pharmacoeconomics and Pharmacoepidemiology 2026 View