Medical U.S. Agent for Foreign Establishments
The U.S. FDA regulates firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. For devices that are exempt from Premarket Notification, Manufacturers (both domestic and non-U.S.) and initial distributors (importers) of medical devices must register their establishments with the U.S. FDA. All registration information must be verified annually between October 1st and December 31st of each year. In addition to registration, foreign manufacturers must also designate a U.S. Agent. Most establishments are required to pay an establishment registration fee to the U.S. FDA. The U.S. FDA establishment registration User Fee for FY 2018 is $4624.
The annual fee for us to serve as your U.S. Agent includes:
- 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
- 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