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.