Post-Market Overview
This page provides a plain English reference for post-market overview 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 post-market overview 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.
Post-market management in China is governed by MDSAR 2021 Chapter VI (Articles 38-70) and implementing Rules. Manufacturers have ongoing obligations including: adverse event reporting and monitoring; annual reporting; post-market surveillance (pharmacovigilance); product labelling and instructions; distribution traceability; recalls and field safety corrective actions; and re-registration at defined intervals (typically 4-5 years depending on device class). NMPA's Center for Medical Device Evaluation (CMDE) coordinates post-market surveillance and may initiate evaluations or impose additional requirements based on safety signals. Serious adverse events must be reported to NMPA within 15 days. Manufacturers must also comply with provincial medical device supervision authority requirements.