www.fdanews.com/articles/156433-china-beefs-up-controls-of-ivd-reagents-buyers-should-monitor-for-compliance
China Beefs Up Controls of IVD Reagents; Buyers Should Monitor for Compliance
June 18, 2013
The China Food and Drug Administration last month released a document outlining acceptance criteria for in vitro diagnostic reagents makers. Among requirements companies must meet are cold storage capability and a computer-based information management system.
International Medical Device Regulatory Monitor
International Medical Device Regulatory Monitor