摘要
通过对美国与我国体外诊断试剂的定义、分类、准入模式及其它管理特点的比对介绍.结合我国体外诊断试剂的生产及 管理现状的分析,指出要进一步完善我国体外诊断试剂的监督管理,需要使监督管理方式与体外诊断试剂的自身特点保 持内在的一致。
This article introduces the definition, classification, premarket admission and other administering specialities about In-Vitro Diagnostic Reagents in the U.S.A. and China. And by analyzing manufacture and administration of In-Vitro Diagnostic Reagents in our country, It is pointed out that a suitable administering model in accordance with the characteristics of In-Vitro Diagnostic Reagents should be adopted to perfect the administration.
出处
《中国医疗器械杂志》
CAS
2005年第2期124-130,共7页
Chinese Journal of Medical Instrumentation
关键词
体外诊断试剂
医疗器械
FDA
监督管理
in-vitro diagnostic reagent, medical device, FDA, administration
