1
关注
918
浏览

what aspects should beconsideredin the application materials?

您还未登录!暂时最多只可查看 1 条回答

登录! 还没有账号?去注册

ku1314520 一阶会员 用户来自于: 广东省深圳市
2023-09-17 22:44

For large-scale imaging equipment (such as CT,MRPET/CT,etc.), if the third-party physiological gating interface isprovided, such as respiratory gating interface, ECG gating interfaceetc., the administrative counterparts shall specify the relevantrequirements of the third-party gating equipment that can be usedtogether in the overview material, such as interface type (includingconnection mode, data protocol, etc.), standards that shall be met,etc.. If the interface is special, the manufacturer, product model, etc.of the equipment that can be used together shall be specified; theverification and validation data tested together with the third-partyequipment shall be provided in the research data; the interface type(including connection mode, data protocol, etc.) and the standard (ifapplicable) shall be specified in the product technical requirements.the technical parameters related to gating shall be tested.


关于作者

问题动态

发布时间
2023-09-17 22:43
更新时间
2023-09-17 22:44
关注人数
1 人关注

推荐内容

透析浓缩物产品有效期应如何确定?透析浓缩物产品应如何开展其稳定性研究?
第一类体外诊断试剂产品备案时,对于产品说明书中【储存条件及有效期】有何要求?
增材制造定制式义齿申报材料中对于增材制造口腔修复用金属粉末与打印参数匹配性如何考虑?
医疗器械产品延续时,技术要求中引用的推荐性标准年代号发生变化,但其引用的内容无实质性变化,是否可以更改标准年代号?
Do we need the control groupin the animal experiment?
如果企业地生产地址要迁往新的生产地址,变更生产许可完成后,提交产品注册证变更前,能否在新地址生产,是否必须等到产品注册证变更再开展生产?
敷料类产品在生物相容性评价研究中,对于浸提液制备和评价项目的选择应注意哪些问题?
对于进口无菌或植入类医疗器械,在提交其注册申请前,是否需要注册人完成PQ(性能验证/确认)吗?
申报产品中既包含颈椎椎间融合器和腰椎椎间融合器,若开展临床试验,是否可以只选其中一种融合器做临床试验?
无源眼科产品如接触镜、人工晶状体进行临床试验时一般都以视力的改善情况为疗效指标,在我国现阶段临床实际中使用较多的是标准对数视力表,是否认可该视力表?