Why Medical Device Facility Registration Required?
Registering establishments (owners or operators of places of business) with the FDA annually is a must for every domestic, foreign manufacturer and initial distributor or importer of medical devices. It is obligatory for every importer of medical devices to US to provide FDA with the medical device facility establishment number for foreign drug 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. Click to learn about 510(k) Medical Device Registration.