REVIEW article
Front. Med.
Sec. Regulatory Science
Volume 12 - 2025 | doi: 10.3389/fmed.2025.1630408
A Decade of Review in Global Regulation and Research of Artificial Intelligence Medical Devices(2015-2025)
Provisionally accepted
- 1Shenyang Pharmaceutical University, Shenyang, China
- 2Peking Union Medical College Hospital, Beijing, China
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Artificial intelligence (AI) and medical devices are increasingly integrated, reshaping global diagnostic paradigms.However, the adaptive learning and opaque nature of AI technologies pose significant challenges to traditional regulatory frameworks. In response, regulatory bodies worldwide, including the U.S., EU, China, Japan, and South Korea, have initiated various policies to address the unique risks posed by AI medical devices (AIMD). These efforts aim to balance innovation with patient safety, yet gaps remain in harmonizing standards across regions and ensuring comprehensive oversight. This study provides a comprehensive analysis of the regulatory policies for AIMD from 2015 to 2025 across key global regions. We examine the evolution of these policies, the academic research progress, the limitations of existing regulations, and emerging trends. By reviewing relevant legislation and literature, this paper offers valuable insights for researchers, manufacturers, and regulators to foster the development of robust regulatory frameworks for AIMD.
Keywords: Artificial Intelligence Medical Device, Regulatory policy, Total Product Life Cycle (TPLC) Management, international harmonization, Innovation and Safety
Received: 29 May 2025; Accepted: 27 Jun 2025.
Copyright: © 2025 Zhang, Li, Liu, CHU and Chen. This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) or licensor are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
* Correspondence: Yuwen Chen, Shenyang Pharmaceutical University, Shenyang, China
Disclaimer: All claims expressed in this article are solely those of the authors and do not necessarily represent those of their affiliated organizations, or those of the publisher, the editors and the reviewers. Any product that may be evaluated in this article or claim that may be made by its manufacturer is not guaranteed or endorsed by the publisher.