Market Surveillance
This page provides a plain English reference for market surveillance under China's NMPA enforcement framework. Full content to be completed during editorial review.
Regulatory basisβ
NMPA enforcement powers are set out in MDSAR 2021 Chapter VII (Legal Liability β Arts. 88β101) and the Medical Device Operation Supervision and Administration Measures (NMPA Order No. 54).
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.
NMPA coordinates post-market surveillance including: sampling and testing of registered devices, monitoring adverse event reports (through the China Medical Device Adverse Event Monitoring System), analysis of complaint data, and assessment of real-world performance. Manufacturers must participate in surveillance, report adverse events within 30 days, and implement recalls when warranted. Surveillance findings inform risk management and potential enforcement actions.