Re-Registration (重新注册)
This page provides a plain English reference for re-registration (重新注册) under China's NMPA regulatory framework. Full content to be completed during editorial review.
Regulatory basis
- MDSAR 2021 (State Council Order No. 739)
- Adverse Event Monitoring & Re-evaluation Measures
- Relevant NMPA orders and announcements
Key requirements
Requirements for re-registration (重新注册) are set out in MDSAR 2021 and implementing measures. See Legislation & Regulations for the full legislative index.
- NMPA — www.nmpa.gov.cn
- CMDE — www.cmde.org.cn
- NMPA Medical Device Registration Query — datasearch.nmpa.gov.cn
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.
Re-registration (重新注册) is required at defined intervals: Class I devices typically every 4 years; Class II devices typically every 4 years; Class III devices typically every 4-5 years. The re-registration application must be submitted 6-12 months before expiration of the existing registration certificate. Documentation must include: updated registration dossier reflecting any manufacturing, design, labeling, or quality changes since last registration; post-market surveillance data; adverse event summary; clinical evaluation updates if applicable; manufacturing site inspection report (if applicable); and payment of registration fees. NMPA reviews re-registration applications through CDE. If no material changes have occurred, expedited review may be possible. Devices approved under prioritized pathways may have different timelines.