摘要
该文通过学习2014年国家食品药品监督管理总局发布的《体外诊断试剂注册管理办法》,探索体外诊断试剂的实际管理经验,持续改进体外诊断试剂的信息化,并进一步进行成本核算效益分析,从而实现医院体外诊断试剂归口统一管理,提高医院工作效率,为患者提供更准确、更高效的服务保障。
This article explored practical management experience of in vitro diagnostic reagents, continuously improved the informatization of in vitro diagnostic reagents and carried out cost-benefit analysis further, through studying 'in vitro diagnostic reagents Registration' issued by China Food and Drug Administration in 2014. So that we achieved a unified centralized management of in vitro diagnostic reagents, improved the working efficiency and provided patients with more accurate and efficient service.
出处
《中国医疗器械杂志》
2016年第3期227-229,共3页
Chinese Journal of Medical Instrumentation
关键词
体外诊断试剂
归口管理
规范管理
in vitro diagnostic reagents
unified centralized management
standardized administration
