U.S. Agent Services for FDA Compliance

Ensure seamless market access to the United States with MDSS as your official FDA U.S. Agent

MDSS provides professional and fully compliant FDA U.S. Agent services for non-U.S. Medical Device and IVD manufacturers. As your trusted liaison with the FDA, we help you meet all mandatory requirements under the U.S. FDA regulations.

The U.S. Agent is a legal requirement for all foreign (non-U.S.) manufacturers registered with the FDA (Food and Drug Administration). The agent serves as a communication link between your company and the FDA, particularly in situations such as:

assisting FDA in communications with the foreign establishment
responding to questions concerning the foreign establishment’s devices that are imported or offered for import into the United States
assisting FDA in scheduling inspections of the foreign establishment and
if FDA is unable to contact the foreign establishment directly or expeditiously, FDA may provide information or documents to the U.S. agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment

The U.S. Food and Drug Administration Agent requires any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States Agent (U.S. Agent) for that establishment

Contact MDSS now

Who Needs a U.S. Agent?

If you are a manufacturer located outside the United States, and plan to:

Market Medical Devices or IVDs in the U.S.
Submit 510 (K), De Novo or other FDA applications
List your products in the FDA database

Then you are required to appoint a U.S. Agent to act as a domestic representative in all FDA-related matters.

Why choose MDSS as your U.S. Agent?

Official U.S. address required by FDA
24/7 availability for FDA contact
Expert support for smooth FDA registration and compliance
Fast turnaround and responsive communication
Integration with our broader regulatory services (EU Representative, UK Responsible Person, Swiss Representative, Australian Sponsor)