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how to provide the CT related overview material andresearch data?

医疗器械技术评审

When applying for registration of PET/CTproducts, if the CT has obtained the registration certificate how to provide the CT related overview material andresearch data?

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si4520 一阶会员用户来自于: 广东省深圳市
2023-09-18 19:57

When applying for registration of PET/CT products, whenCT has obtained a separate registration certificate, the overviewmaterial and research data of CT part shall include the followingcontents: the manufacturer, model and registration certificate numberof CT shall be specified in the overview material, and whether thereis difference between CT in PET/CT system and CT with registrationcertificate. If there are differences. the administrative counterpartsshall provide the data of difference analysis and submit the research data of the impact of differences on safety and effectiveness.Ifthere is no difference between CT in PET/CT and CT in the originalregistration certificate, the research data of PET/CT system can beprovided and the research data of CT does not need to be providedseparately.

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发布时间: 2023-09-18 19:56

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