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Registration Technical Guidance

This page indexes registration technical 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.

Medical device registration in China follows a risk-based classification system (Class I, II, III). The registration process includes: application submission, technical review, clinical evaluation (when required), site inspection, and approval. Registration validity is typically 5 years from approval date, after which re-registration is required. Expedited pathways exist for breakthrough devices and products addressing unmet clinical needs.