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

Viewpoints and Perspectives in AI (13) Artificial Intelligence (1960) Ethical, Legal, and Social Issues in AI (89) Applications of AI (230)

Published on in Vol 3 (2024)

This is a member publication of Bodleian Libraries (Jisc)

Preprints (earlier versions) of this paper are available at https://preprints.jmir.org/preprint/46871, first published .
Regulatory Frameworks for AI-Enabled Medical Device Software in China: Comparative Analysis and Review of Implications for Global Manufacturer

Regulatory Frameworks for AI-Enabled Medical Device Software in China: Comparative Analysis and Review of Implications for Global Manufacturer

Regulatory Frameworks for AI-Enabled Medical Device Software in China: Comparative Analysis and Review of Implications for Global Manufacturer

Authors of this article:

Yu Han1 Author Orcid Image ;   Aaron Ceross1 Author Orcid Image ;   Jeroen Bergmann1, 2 Author Orcid Image
Article Authors Cited by (9) Tweetations Metrics

Journals

  1. Han Y, Ceross A, Bergmann J. More than red tape: exploring complexity in medical device regulatory affairs. Frontiers in Medicine 2024;11 View
  2. Liu Y, Li S, Yu J, Cao J, Ma Q, Li M, Zheng Y, You Y, Lv W, Li Q, Zhang C, Piao M. Demand analysis of transitional care for patients undergoing minimally invasive cardiac interventions with AI-driven solutions: a mixed-methods approach. BMC Nursing 2025;24(1) View
  3. Ong A, Taribagil P, Sevgi M, Kale A, Dow E, Macdonald T, Kras A, Maniatopoulos G, Liu X, Keane P, Denniston A, Hogg H. A scoping review of artificial intelligence as a medical device for ophthalmic image analysis in Europe, Australia and America. npj Digital Medicine 2025;8(1) View
  4. Rahi S, Lather V, Rana A, Pandit J. Comprehensive Framework for the Global Regulation and Approval of AI-Integrated Medical Devices. Applied Drug Research, Clinical Trials and Regulatory Affairs 2025;11 View
  5. Zhang S, Li Y, Liu W, Chu Q, Wang S, Li J, Chen Y. A decade of review in global regulation and research of artificial intelligence medical devices (2015–2025). Frontiers in Medicine 2025;12 View
  6. Montalbano P. Ethical and Legal Considerations of Medical Artificial Intelligence. Primary Care: Clinics in Office Practice 2025 View

Books/Policy Documents

  1. Arfan S, Saleem R, Irshad L, Anas M, Ahmed Khattak W, Majeed M, Naz J, Umar A, Ahmad T, Ramzan M. Tailored Light Emitters For Biomedical Applications. View
  2. Khandelwal P, Gupta S. AI in Diagnostic Radiology. View

Conference Proceedings

  1. Sah H, Ramesh M, C A. 2025 Emerging Technologies for Intelligent Systems (ETIS). Regulating Software as Medical Device (SaMD): A Comprehensive Overview of The International Medical Device Regulators Forum (IMDRF) Framework and Gap Analysis of Indian Medical Devices Rules, 2017 View