关于我国体外诊断试剂监督管理改革的建议

Advice on reformation of administration for in vitro diagnostic kits

本文综述了美国、欧盟、日本、中国目前对体外诊断产品(试剂)监督管理的现状以及我国存在的问题。并根据我国具体情况提出了对体外诊断试剂监督管理的改革建议。

This review summarizes the supervisory actuality for the in vitro diagnostic products （kits） of USA, EU, Japan and China respectively,and some obvious problems in our country. At the same time,it puts forward some innovatory proposal for the suspension of in vitro diagnostics according to our concrete conditions.