The US Food & Drug Administration requires than any non-U.S. firm that market medical devices in the U.S. must register their establishment and identify a U.S. Agent with an address in the U.S.

Key functions of the U.S. Agent are:

Assist the FDA in communicating with your non U.S. establishment


Respond to questions from the FDA about your company’s products that are imported into the U.S.


Assist the FDA in scheduling inspections of your establishment.


Receive documents from the FDA on behalf of your company.

With over 20+ years of experience communicating with the FDA, MDCI is uniquely qualified to act as your U.S. Agent.