Technical requirements for point-of-care testing in vitro diagnostic reagents registration
10.3760/cma.j.issn.1009-9158.2014.11.005
- VernacularTitle:POCT 类体外诊断试剂注册技术要求解析
- Author:
Yaohua LI
- Publication Type:Journal Article
- Keywords:
Point-of-care systems;
Indicators and reagents;
Registries;
Professional competence
- From:
Chinese Journal of Laboratory Medicine
2014;(11):812-816
- CountryChina
- Language:Chinese
-
Abstract:
POCT 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.
