{"id":27776,"date":"2023-05-17T16:36:15","date_gmt":"2023-05-17T14:36:15","guid":{"rendered":"https:\/\/www.thema-med.com\/?page_id=27776"},"modified":"2026-07-02T09:18:30","modified_gmt":"2026-07-02T07:18:30","slug":"us-agent","status":"publish","type":"page","link":"https:\/\/www.thema-med.com\/en\/us-agent\/","title":{"rendered":"US Agent"},"content":{"rendered":"

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THEMA USA<\/span>
\n2929 Arch Street<\/span>
\nPhiladelphia, PA 19104<\/span><\/h2>\n<\/div><\/div><\/div><\/div><\/div>

In the U.S. medical device and IVD market, the role of U.S. Agent<\/a> is critical for all non-U.S.-based organisations involved in the manufacture and distribution of imported devices.<\/p>\n

FDA requires non-U.S. organisations required to carry out establishment registration<\/a> to appoint a U.S.-based contact person to whom they can turn for any communication, without having to worry about language or time zone issues.<\/p>\n

The U.S. Agent’s contact details<\/strong> are communicated by the organisation through the FDA Unified Registration and Listing System (FURLS).<\/p>\n

In turn, within 10 working days and again via the FURLS system, the U.S. Agent must complete the confirmation<\/strong> process to act as the organisation’s representative.<\/p>\n

The U.S. Agent has the following responsibilities<\/strong>:<\/p>\n