Foreign establishments or facilities exporting to the United States must identify an FDA U.S. Agent during the registration process.
Each foreign establishment may designate only one U.S. Agent.
FDA treats representations by the U.S. Agent as those of the foreign facility, and will consider information or documents provided to the U.S. Agent the equivalent of providing the information or documents to the foreign facility.
The U.S. Agent has no responsibility related to adverse events under the Medical Device Reporting regulation.
As U.S. Agent, we register your domestic and or foreign company at no extra cost. Join satisfied clients in over 100 countries including Canada, Mexico, Brazil, Australia, India, South Korea, Japan, China, Russia, Greece, Portugal, Spain, Italy, France, Switzerland, Belgium, Netherlands, Sweden, United Kingdom, Ireland.
■ Commercial Agent
■ Customs Broker
■ Initial Importer
■ Importer of Record
■ FSVP Importer
We make the process very easy. Get the better service your company deserves.
Your company’s commercial business in the United States cannot be conducted through the U.S. Agent designated for the purpose of FDA Registration.