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

ABSTRACT: The China State Council released the new generation artificial intelligence (AI) development plan, outlining China's ambitious aspiration to assume global leadership in AI by the year 2030. This initiative underscores the extensive applicability of AI across diverse domains, including manufacturing, law, and medicine. With China establishing itself as a major producer and consumer of medical devices, there has been a notable increase in software registrations. This study aims to study the proliferation of health care-related software development within China. This work presents an overview of the Chinese regulatory framework for medical device software. The analysis covers both software as a medical device and software in a medical device. A comparative approach is employed to examine the

SUBMITTER: Han Y 

PROVIDER: S-EPMC11319888 | biostudies-literature | 2024 Jul

REPOSITORIES: biostudies-literature