how to provide the CT related overview material andresearch data? - 分享质量人的知识和经验

登录

1: 关注

1291: 浏览

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?

好问题 0 评论收藏举报

查看全部 1 个回答

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.

赞同 0 0评论

关于作者

: 打豆豆 二阶会员
这家伙很懒，还没有设置简介

99: 回答

93: 文章

974: 问题

问题动态

发布时间: 2023-09-18 19:56

更新时间: 2023-09-18 19:57

关注人数: 1 人关注

相关问题

Medical endoscopes have several models, how tochoose the typical model for type test?: 1288 浏览 1 关注 1 回答 0 评论

What are the requirements for adding models oraccessories in the Change of Permission Items?: 1484 浏览 1 关注 1 回答 0 评论

How can a design space beverified at commercial scale for biological products?: 1366 浏览 1 关注 1 回答 0 评论

新设计的产品必需建立产品开发设计档案DHF（Design History File）, 那么DHF里面应该要包含什么样的内容呢？: 9290 浏览 3 关注 1 回答 0 评论

Do we need the control groupin the animal experiment?: 1425 浏览 1 关注 1 回答 0 评论

How can limits for cleaning purposes be established?: 1132 浏览 1 关注 1 回答 0 评论

Is it acceptable to save paper printed records instead of original electronic records?: 1324 浏览 1 关注 1 回答 0 评论

Is the use of LD50 to determine Health-Based Exposure Limits for drug products acceptable?: 1281 浏览 1 关注 1 回答 0 评论

can we onlycompare the key performances?: 1490 浏览 1 关注 1 回答 0 评论

How are sub-batches obtained and labelled?: 1292 浏览 1 关注 1 回答 0 评论

推荐内容

问 What are the requirements for adding models oraccessories in the Change of Permission Items?: 1484 浏览 1 关注 1 回答 0 评论

问导尿管产品在说明书是否需要补充使用润滑剂的风险提示信息?: 1432 浏览 1 关注 1 回答 0 评论

问第二类无源医疗器械申报延续注册时，申请表中应如何撰写“产品概述”和“有关产品安全性、有效性主要评价内容”？: 1743 浏览 1 关注 1 回答 0 评论

问医疗器械软件中的测量功能，注册申报资料应关注哪些问题？: 1220 浏览 1 关注 1 回答 0 评论

问 How to determine the essential performance ofimmunity test in EMC test of active medical devices?: 1265 浏览 1 关注 1 回答 0 评论

问通过eRPS 系统进行电子申报的事项如何查询申报进度?: 1211 浏览 1 关注 1 回答 0 评论

问新研制的尚未列入分类目录的医疗器械，是否定要在注册申报前进行分类界定?: 1229 浏览 1 关注 1 回答 0 评论

问膝关节假体类产品通常在产品技术要求中规定哪些性能指标？: 1445 浏览 1 关注 1 回答 0 评论

问创面敷贴产品预期用途与《医疗器械分类目录》一致，但是申报产品中含有高分子材料，是否可以豁免临床评价？: 959 浏览 1 关注 1 回答 0 评论

问定制式固定义齿如何选择典型型号进行检测？: 1632 浏览 1 关注 1 回答 0 评论

技术支持 WeCenter © 2025 粤ICP备2023143277号-1