Why is Medical Device Facility Registration Required?
Registering medical device establishments with the FDA annually is a must for every domestic and foreign manufacturer and initial distributor or importer of medical devices. It is obligatory for every importer of medical devices to the US to provide the FDA with the medical device facility establishment number for foreign manufacturers and importers/distributors.
Failure to do this results in delay or refusal of medical devices. Registering establishments or facilities with FDA is known as establishment registration.