体外诊断试剂

“IVD”全名叫“in vitro diagnostic products”,中文译为体外诊断产品,IVD是指医疗器械、体外诊断试剂以及药品,IVD作为医疗器械的分支,有特有的界定和法规监管。

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国家药监局关于实施《体外诊断试剂分类目录》有关事项的通告(2024年第17号) 发布时间:2024-05-11   为贯彻落实《医疗器械监督管理条例》(国务院令第739号)要求,更好地指导体外诊断试剂分类,依据《体外诊断试剂注册与备案管理办...
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医疗器械
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医疗器械

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