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.（Chin J Lab Med，2014,37：815-819） Key words: Point-of-care systems; Indicators and reagents; Registries; Professional competence
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