Li Haining, Mu Ruihong, Ren Haiping, Bai Dondting
National Institute for Control of Pharmaceutical and Biological Products, Beijing, 100050.
Zhongguo Yi Liao Qi Xie Za Zhi. 2011 Jan;35(1):68-70.
The regulatory history and status of in vitro diagnostic reagents (IVD) at home and abroad are introduced. Suggestions are also provided on the administration of IVD.
介绍了国内外体外诊断试剂（IVD）的监管历史和现状。还就体外诊断试剂的管理提出了建议。
