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SaMD and AI/ML Guidance

This page indexes SaMD and AI/ML guidance documents published by NMPA and CMDE. Content is being expanded. Below are direct links to official sources.

Finding official guidance​

NMPA technical guidance documents are published on:

  • CMDE website: www.cmde.org.cn β†’ ζŒ‡ε―ΌεŽŸεˆ™ (Technical Review Guidelines)
  • NMPA website: www.nmpa.gov.cn β†’ εŒ»η–—ε™¨ζ’° β†’ 法规文仢
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.

NMPA released guidance on Software as a Medical Device (SaMD) and AI/ML-based medical devices in 2021-2022. Key requirements include: algorithm validation, cybersecurity assessment, performance stability testing across intended use populations, and transparency in AI decision-making. CMDE provides specific technical review guidelines for machine learning model development, validation datasets, and post-market monitoring strategies.