Medical Device Listing

September 9, 2014

US FDA MEDICAL DEVICE Establishment Registration

Foreign and Domestic Medical Device Manufacturers and initial distributors / importers must register their establishments with the 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. Beginning October 1, 2007, most establishments are required to pay an establishment registration fee. Establishment Registration U.S. Agents