摘要POCT类体外诊断试剂具有操作简便、现场检测、标本处理要求低、快速出具结果等一般特点，通常适用小型检验仪器，是临床检验中心高通量、大型自动化检验的有力补充，具有一定的特点。依据国务院2014年颁发的《医疗器械监督管理条例》，结合国家食品药品监督管理部门颁发的系列规定、办法，对POCT类体外诊断试剂产品的注册申报相关技术要求进行探讨，为注册相关人员的工作提出建议。

abstractsPOCT in vitro diagnostic reagents featuring with easy operation , on-site testing, low requirements for specimen processing , fast results , usually applied small testing equipment , is a strong complement to high-throughput , large automated tests in clinical laboratory centers.According to the State Council issued in 2014 “Supervision and Regulation of Medical Devices ” and series regulations and management practices issued by the China Food and Drug Administration , conduct an investigation in POCT IVD registration relevant technical requirements and give some advice for the relevant personnel of register work.