摘要
根据《体外诊断试剂注册管理办法》《体外诊断试剂临床试验技术指导原则》及《免于进行临床试验的体外诊断试剂临床评价资料基本要求(试行)》等相关法规的内容,对25-羟基维生素D定量测定试剂盒临床有效性评价的要求进行总结归纳。
According to the“In Vitro Diagnostic Reagents Registration Management Measures”,“In Vitro Diagnostic Reagents Clinical Trial Technical Guidelines”and“In Vitro Diagnostic Reagents Exempt from Clinical Trial Clinical Evaluation Data Basic Requirements(Trial)”and other relevant regulations,25-hydroxy vitamins D.The requirements for clinical effectiveness evaluation of the quantitative determination kit are summarized.
作者
李风梅
张龚敏
吴林蔚
LI Feng-mei;ZHANG Gong-min;WU Lin-wei(Center for Certification and Evaluation,Guangdong Drug Administration,Guangdong Guangzhou 510080)
出处
《中国医疗器械信息》
2020年第17期13-15,共3页
China Medical Device Information
关键词
体外诊断试剂
临床试验
临床评价
in vitro diagnostic reagent(IVD Reagents)
clinical test
clinical evaluation
