China is improving its SaMD regulations to better support the rapid development of its digital health industry. APACMed China has launched the digital regulatory project in 2022 to share APAC practices and shape policies on a continuous basis. This paper summarizes the current regulatory practices in TGA and Singapore and provides specific recommendations to Chinese regulators with a focus on the biggest pain point in China – the classification of software. This paper provides a detailed analysis of the classification issue and shares concrete policy recommendations to policymakers.

This Paper is only available in Chinese.

为促进数字医疗行业的快速发展，中国正在调整其软件监管的政策。APACMed China于2022年启动了数字医疗法规的倡导工作，以便分享亚太地区的做法，持续开展政策塑造工作。本建议报告总结了两个代表性国家，澳大利亚和新加坡的做法，聚焦行业普遍关注的分类界定痛点。在分类问题上还进行了详细的分析，并研提了具体的行业建议。