Owners or operators of establishments involved in the production and distribution of medical devices intended for commercial distribution in the United States—including those that are imported for export only—must register annually with the Food and Drug Administration (FDA).
These facilities include foreign and domestic:
- Contract manufacturers
- Specification developers
- Relabelers /repackers
- Initial importers
- Foreign exporters.
In addition, most establishments must also list the devices they make, and the activities performed on those devices. Facilities that do not properly renew can be locked out of the U.S. market.
This is a reminder that renewal registrations with the FDA are due. The current renewal period is open through December 31, 2023. Failure to submit, renew, update, or cancel a registration can result in civil or criminal action, as well as import restrictions.
Registrar Corp offers facility registration services, including identifying a company’s registration obligations, potential exemptions, and registering foreign or domestic companies—as well as service as a U.S. agent for foreign facilities. If you have questions on how this may impact your business, reach out to Mohawk Global Trade Advisors.
By Clarissa Chiclana