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

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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?

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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.

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发布时间: 2023-09-17 16:45

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