Import Restrictions Possible for Unregistered Medical Device Facilities

Foreign and domestic medical device facilities that do not properly renew their registrations with the Food and Drug Administration can be locked out of the U.S. market. Renewals for such facilities are due each year.

Owners or operators of establishments involved in the production and distribution of medical devices intended for commercial distribution in the U.S., including those that are imported for export only, must register annually with the FDA. These facilities include foreign and domestic contract manufacturers, specification developers, relabelers/repackers, and initial importers and foreign exporters. Most such establishments must also list the devices they make and the activities performed on those devices at that establishment.

Failure to submit, renew, update, or cancel a registration can result in civil or criminal action as well as import restrictions.

Foreign and domestic medical device facilities, as well as the companies that source from them, should ensure they renew their registrations on time. The current renewal period opened Oct. 1 and will close Dec. 31. Renewals are mandatory regardless of when the initial registration occurred.

FDA Solutions Group offers facility registration services, including identifying a company's registration obligations and potential exemptions and registering foreign or domestic companies, as well as service as a U.S. agent for foreign facilities. To learn more and ensure your company is registered during this year’s renewal period, please contact Domenic Veneziano at (202) 734-3939.