What are the requirements for adding models oraccessories in the Change of Permission Items? - 分享质量人的知识和经验

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What are the requirements for adding models oraccessories in the Change of Permission Items?

医疗器械技术评审

What are the requirements for adding models oraccessories in the Change of Permission Items?

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ku13145 二阶会员用户来自于: 广东省深圳市
2023-09-17 16:46

The contents contained in one registration certificate shallcomply with the requirements of“Guidance of registration unitsdivision for medical device”. Whether it is able to add models oraccessories into the registration certificate of registered productsdepends on the difference between the new model and the originalmodel, as well as the relevance between the new accessories andthe original products. If the newly added models or accessories andregistered products can be divided into the same registration unitaccording to the guidance, they can be added via the Change ofPermission Items。

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发布时间: 2023-09-17 16:46

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