the question abaot of non-medical device components? - 分享质量人的知识和经验

登录

1: 关注

1610: 浏览

the question abaot of non-medical device components?

医疗器械技术评审

Could non-medical device components be includedin the composition components of active medical device?

好问题 0 评论收藏举报

您还未登录!暂时最多只可查看 1 条回答

去登录! 还没有账号?去注册

1 回答

ku13145 二阶会员用户来自于: 广东省深圳市
2023-09-17 16:45

For the non-medical device components, they are not allowedto be submitted separately, but can be submitted as components ofmedical devices.
If this component is submitted as part of the medical device, itcan be considered and evaluated as part of the whole device, and itshould be inspected and verified together with the whole device.Ifadministrative counterparts does not submit this component, or doesnot inspect or verify the component with the whole device, then itshall not be included in the product structure composition.For example: Printers, Power supply cord, Fiber optic cablesfor endoscope, Connecting cables of neutral electrode, etc. They allbelong to this situation.

赞同 0 0评论

关于作者

: cyxwvoarn 二阶会员
这家伙很懒，还没有设置简介

35: 回答

20: 文章

966: 问题

问题动态

发布时间: 2023-09-17 16:45

更新时间: 2023-09-17 16:45

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?: 1256 浏览 1 关注 1 回答 0 评论

Do we need the control groupin the animal experiment?: 1409 浏览 1 关注 1 回答 0 评论

How do the new requirements affect importers of medicinal products?: 1192 浏览 1 关注 1 回答 0 评论

Why would a design space beverified during the product lifecycle?: 1327 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?: 1467 浏览 1 关注 1 回答 0 评论

Does the EDQM provide safety data sheets (SDSs) for the standards it supplies ?: 1333 浏览 1 关注 1 回答 0 评论

What are the “systems” in “computer or related systems” in § 211.68?: 1276 浏览 1 关注 1 回答 0 评论

How often should audit trails be reviewed?: 1283 浏览 1 关注 1 回答 0 评论

How to determine the naming rules for softwareversion?: 1304 浏览 1 关注 1 回答 0 评论

What reference standards does the EDQM supply?: 1387 浏览 1 关注 1 回答 0 评论

推荐内容

问体外诊断试剂临床试验使用的试剂批次有何要求?: 1509 浏览 1 关注 1 回答 0 评论

问二类无源产品货架有效期变更，需要提交哪些材料？需进行质量管理体系核查吗？: 1006 浏览 1 关注 1 回答 0 评论

问包类产品的分类编码如何来确定?: 1208 浏览 1 关注 1 回答 0 评论

问 ECMO产品动物试验评价指标包括哪些？: 976 浏览 1 关注 1 回答 0 评论

问环氧乙烷（EO）残留限量的指标如何确定？: 1019 浏览 1 关注 1 回答 0 评论

问何时需要以及如何递交医疗器械临床试验数据库？: 1261 浏览 1 关注 1 回答 0 评论

问同种异体原材料混批加工的追溯问题？: 1718 浏览 1 关注 1 回答 0 评论

问 If the Android APP is registered, isit necessary to be tested when adding iOS APP?: 1306 浏览 1 关注 1 回答 0 评论

问厂区位置路线图和厂区总平面如有何要求？: 1272 浏览 1 关注 1 回答 0 评论

问关于灭菌批和生产批的关系问题？: 1390 浏览 1 关注 1 回答 0 评论

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