Han Yu, Ceross Aaron, Bergmann Jeroen
University of Oxford, Oxford, United Kingdom.
Department of Technology and Innovation, The University of Southern Denmark, Denmark, Denmark.
JMIR AI. 2024 Jul 29;3:e46871. doi: 10.2196/46871.
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.
中国国务院发布了新一代人工智能（AI）发展规划，勾勒出中国到2030年在人工智能领域占据全球领先地位的宏伟抱负。这一举措凸显了人工智能在包括制造业、法律和医学等不同领域的广泛适用性。随着中国成为医疗设备的主要生产国和消费国，软件注册数量显著增加。本研究旨在探讨中国境内与医疗保健相关的软件开发的扩散情况。这项工作概述了中国医疗器械软件的监管框架。分析涵盖了作为医疗器械的软件和医疗器械中的软件。采用比较方法来审视中国、美国和欧洲对具有人工智能和机器学习功能的医疗器械的监管规定。该研究强调了中国境内与医疗保健相关的软件开发的显著扩散，这导致对全面监管指导的需求增加，特别是对国际制造商而言。比较分析揭示了这三个地区不同的监管框架和要求。本文提供了中国医疗软件监管现状的有用概述，并确定了人工智能和机器学习技术的快速发展所带来的监管挑战。对于旨在应对复杂监管环境的国际制造商和利益相关者来说，理解这些挑战至关重要。
