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could the software information in the devicecertificate be updated during Registration Renewal?

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ku1314520 一阶会员 用户来自于: 广东省深圳市
2023-09-17 22:13

Active medical devices and the cooperated softwareare independent medical devices, each with its own registrationcertificate, and the version of the cooperated software is permissionitems of the registration certificate of medical devices, so it cannot bechanged during the Registration Renewal.
If the medical device is meant to be used with the updatedversion of the software, it shall apply for the Change of PermissionItems, and provide the safety and effectiveness evidence of thecooperation with the new version of the software. If there's noChange of Permission Items submitted, the medical device cannot beused with the new version of software, while still be able to be usedwith the previous version the software.


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发布时间
2023-09-17 22:13
更新时间
2023-09-17 22:13
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