Recalls and Field Safety Corrective Actions
This page provides a plain English reference for recalls and field safety corrective actions 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 recalls and field safety corrective actions 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.
Recalls and field safety corrective actions (召回) are governed by MDSAR 2021 Articles 53-58 and the Medical Device Recall Management Rules. Recalls are classified as: Class I (risk of serious injury or death); Class II (potential adverse health consequences); Class III (unlikely to cause adverse health consequences). Manufacturers must: notify NMPA immediately upon discovering a serious safety issue; submit a recall plan within 5 working days; implement recall measures and verify effectiveness; document all recalled units and their disposition; report completion to NMPA. NMPA may initiate recalls if manufacturers fail to do so. Medical Device Quality Management System (MDQMS) requirements apply. Recalls must be coordinated through provincial authorities and distributors. NMPA publishes recall notices on its official website. Manufacturers must also implement corrective actions to prevent recurrence.