Digital Health Regulatory Framework

This page provides a plain English reference for digital health regulatory framework under China's NMPA regulatory framework for digital health. Full content to be completed during editorial review.

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Regulatory basis

NMPA's digital health and SaMD framework is based on:

• MDSAR 2021 general device framework applied to software
• NMPA standalone software classification guidance (独立软件分类界定指导原则)
• NMPA SaMD registration technical review guidance (人工智能医疗器械注册审查指导原则, 2022)
• IEC 62304 as adopted in China's YY/T 0664 standard

Disclaimer

Content on this site is written with AI assistance and is intended as a navigation aid only. Always verify against official NMPA sources before making regulatory decisions. Not affiliated with NMPA or any Chinese Government body. Not legal or regulatory advice.