Imported active medical device includes a varietyof configurations when marketed in original country, butonly part of the configurations was selected when submittedin China. Will it be accepted?
1 回答
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.
这家伙很懒，还没有设置简介
