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 → 指导原则 (Technical Review Guidelines)
- NMPA website: www.nmpa.gov.cn → 医疗器械 → 法规文件
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 5 years from approval date for Class II and III devices, after which mandatory re-registration is required. Class I devices do not require re-registration. Expedited pathways exist for breakthrough devices and products addressing unmet clinical needs.