Adverse Event Monitoring & Re-evaluation Measures
This page provides a plain English reference for adverse event monitoring & re-evaluation measures in China's medical device regulatory framework. Full content to be completed during editorial review.
Overviewβ
See MDSAR 2021 for the primary regulation. This page covers the implementing measure or standard listed above, explaining its scope, key requirements, and relationship to MDSAR 2021.
Official sourceβ
Official texts are published on www.nmpa.gov.cn and the State Council website at www.gov.cn.
Disclaimer
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.