注册的过程称之为工厂注册(Establishment Registration);同时,这些企业必须向FDA确认他们进行商业分销的医疗器械,包括仅用于出口的器械,这个过程称之为医疗器械列示(Medical Device...
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Who is required to pay the establishment registration fee?
谁必须支付企业注册费?
No, all establishments who are required to pay have the same establishment registration User fee.
不能,所有被要求付费的企业都必须付相同的注册费。
Where approval by the relevant authorities is required by law or administrative regulations, the approval document shall also be submitted when applying for establishment registration.
法律、行政法规规定须报经有关部门审批的,应当在申请设立登记时提交批准文件。
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