Regulatory Requirements

The U.S. FDA is responsible for regulating firms who manufacture, repackage, relabel, and/or import medical devices sold in the United States. For devices that are exempt from Premarket Notification, Manufacturers (both domestic and non-U.S.) and initial distributors (importers) of medical devices must register their establishments with the U.S. 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. The new U.S. Food and Drug Administration Safety and Innovation Act (FDASIA) imposes many Medical Device Establishment Registration and Listings requirements, effective October 1, 2012.

Failing to register either yourself as an importer or your foreign manufacturer could lead to fines and penalties from the US FDA. Penalties could include an Import Alert, which can cause severe delays in shipments. Registration also demonstrates to distributors, import brokers, and insurers your professionalism and understanding of the regulations.

If you are not registered with U.S. FDA

 

FDA Atty’s team of Medical Device Regulatory Specialists provides guidance on required elements, formats, and particularities of submissions, including:

  • Help determining whether registration exclusions apply and, if not, we will prepare and submit your registrations with U.S. FDA and make changes, updates and cancellations as needed at no extra cost.
  • Assistance determining if U.S. FDA Medical Device User Fees