FDA法规 U.S.FDA 
美国代理人 Medical Device US Agent
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非美国公司必须向FDA提交与FDA联络的美国代理的名称，地址和电话号码。以确保后续 FDA能够及时联系到美国代理，并传达重要通信
The foreign establishment that manufactures, processes or conducts related activities of the medical device that are sold in the United States are required by FDA to identify a United States agent (U.S. agent) during establishment registration.
