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 regulations governing medical devices with AI and machine learning in China, the United States, and Europe. The study highlights the significant proliferation of health care–related software development within China, which has led to an increased demand for comprehensive regulatory guidance, particularly for international manufacturers. The comparative analysis reveals distinct regulatory frameworks and requirements across the three regions. This paper provides a useful outline of the current state of regulations for medical software in China and identifies the regulatory challenges posed by the rapid advancements in AI and machine learning technologies. Understanding these challenges is crucial for international manufacturers and stakeholders aiming to navigate the complex regulatory landscape.