Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a medical device imported into the United States must identify a United States agent (U.S. Agent) for that establishment.

The US Agent must reside in the United States or maintain a business in the United States. The responsibilities of the US Agent include:

  • 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 US Agent, and such an action shall be considered to be equivalent to providing the same information or documents to the foreign establishment.​​
Foreign establishment

US Agent Services

We have years of experience serving as US Agent to foreign establishments and are committed to providing first in class service to our customers.

Facility Registration

Whether you have a single facility or multiple facilities to register with the FDA we are here to help walk you through the entire process.

FDA Furls Data Entry Services

We offer product registration services to our customers. Whether it is a single product or thousands, we will get the job done.

Initial Importer Services

We act as an initial importer, maintain quality system procedures, and ensure a smooth approval process through US customs.