Annual Reports
This page provides a plain English reference for annual reports 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 annual reports 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.
Annual reports in China must be submitted to NMPA within a specified timeframe following calendar year end (typically by March 31 of the following year). Reports must include: adverse event summaries, post-market surveillance data, corrective actions taken, manufacturing/quality changes, and updated product information. Class III devices typically require more detailed reporting than Class I devices. Manufacturers should reference the specific forms and templates available on the NMPA Medical Device Registration system (CDE portal) and the implementing Rules for Medical Device Registration (MDSAR 2021 Article 40-42).