Medical Devices regulation in USA: FDA Registration and Listing

Medes Inc – USA: FDA Designated Agent – Arazy Group

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All Non-USA manufacturers of medical equipment who wish to market their products under their own name in the US market must appoint a Regulatory Designated Agent in order to meet FDA requirements.

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What are the Responsibilities of the US Regulatory Designated Agent?

The responsibilities of the Regulatory Designated Agent are:

Assisting FDA in communications with foreign establishments,
Responding to questions concerning the products of foreign establishment that are imported or offered for import into the United States.
Assisting FDA in scheduling inspections of the foreign establishment

Reference for the need to appoint a Regulatory Agent

FDA new regulations implement section 417 of the Food and Drug Administration Modernization Act of 1997 (FDAMA)