关于IVD综述资料中第（五）部分编写注意事项
中国器审 2018-08-09
问：
关于体外诊断试剂综述资料中第（五）部分编写注意事项
答 :
体外诊断试剂注册申报资料中综述资料第（五）部分：“其他”内容的编写往往容易被忽视，该部分内容是对拟申报产品创新性和已上市同类产品情况的总结，包括同类产品在国内外批准上市的情况、相关产品所采用的技术方法及临床应用情况，申请注册产品与国内外同类产品的异同等。对于新研制的体外诊断试剂产品，需要提供被测物与预期适用的临床适应症之间关系的文献资料。
如境内、外已有同类产品上市，申请人应说明已上市同类产品的注册人、产品名称以及数量，并比较拟申报产品与同类产品在技术方法、产品性能及临床应用情况等方面的异同，在境内外临床使用的情况等。
如境内、外尚无同类产品上市，或申报产品改变常规预期用途并具有新的临床诊断意义，申请人需提供被测物与预期的临床适应症之间关系的文献资料，包括相关指南性文件、专家共识等。
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