The US Food and Drug Administration has updated regulations which requiring all foreign manufacturers of medical devices and other FDA regulated products to designate and appoint a US Agent to represent the manufacturer with the FDA. The US Agent must be a US resident with a formal business address in the United States.
As the premiere US Agent service, IRC has been serving foreign manufacturers for over ten plus years. Our experience and expertise in translating your needs and meeting your objectives is unparalleled. We offer a wide variety of services as US Agent, from simple representation to enhanced consultation.