体外诊断试剂管理的现状及监管对策

The Status Quo of In-Vitro Diagnostic Reagents' Administration and its Countermeasures

通过对我国体外诊断试剂的管理模式、历史进程及流通、使用现状的情况调查,结合美国FDA的基本管理模式,阐述了 为使体外诊断试剂安全有效,必须加强对流通、使用领域的监管并提出有关监管对策。

This article introduces the pattern of administration,evolvement,distribution and using status quo about In-Vitro Diagnostic Reagents in China.With relation to the administration pattern of the FDA in the U.S.,the paper points out that strengthened supervision and administration for In-Vitro Diagnostic Reagents must be carried out in the realm of distribution and uses in order to ensure the safety and the efficiency.The article also suggests some countermeasures on the administration of In-Vitro Diagnostic Reagents.