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NMPA Guidance Index by Topic

This page provides an index and plain English summary of nmpa guidance index by topic published by NMPA and CMDE. Full content to be completed during editorial review.

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.

This page will provide a categorical index of NMPA guidance documents organized by topic including: software as medical device classification, clinical evaluation methods, quality management systems, risk management, software validation, AI/machine learning applications, post-market surveillance, and device-specific guidance. Each topic will include English summaries of key guidance documents with links to original Chinese sources on CMDE and NMPA websites.