SaMD Classification
This page provides a plain English reference for samd classification under China's NMPA regulatory framework for digital health. Full content to be completed during editorial review.
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
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.
NMPA classifies SaMD into three risk categories (Class I, II, III) based on intended use and risk level. Class I devices (lowest risk) are exempt from premarket registration under certain conditions. Class II devices require registration through the standard pathway. Class III devices (highest risk) require registration with clinical evaluation and more stringent quality controls.