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butonly part of the configurations was selected when submittedin China. Will it be accepted?

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ku13145 二阶会员 用户来自于: 广东省深圳市
2023-09-17 16:37

When imported medical devices is submitted registrationin China, the scope of application of the medical device shall notexceed the scope when approved in the original country. If onlypart of the configuration is submitted, and the submitted part can beapplied independently and the manufacture ensures its safety andeffectiveness, manufactures can make reductions on the basis of theapproved scope of original country.


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发布时间
2023-09-17 16:36
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2023-09-17 16:37
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