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Register a Medical Device Establishment with U.S. FDA

U.S. FDA CITATION: 21 C.F.R. § 807 (2016)

Firms that manufacture, repackage, relabel, or import medical devices sold in the United States must register with the U.S. Food and Drug Administration (FDA), designate an Official Correspondent for FDA communications, and list their devices with FDA . Facilities located outside of the United States must also designate a U.S. Agent at the time of registration.

Registrar Corp’s Regulatory Specialists will register your medical device establishment,  act as your Official Correspondent, list your devices with FDA, and issue you a Certificate of Registration. For facilities outside of the United States, Registrar Corp will also serve as your U.S. Agent.

For assistance with FDA medical device registration, simply complete the form below.