Import Restrictions Possible for Unregistered Medical Device Facilities
Foreign and domestic medical device facilities that fail to renew their registrations with the Food and Drug Administration (FDA) may face import restrictions and be locked out of the U.S. market. It is crucial for owners or operators of such establishments involved in the production and distribution of medical devices intended for commercial distribution in the U.S. to annually register with the FDA. Failure to comply with registration requirements can result in civil or criminal action.
Key Points:
- Annual registration renewal: Foreign and domestic medical device facilities, including contract manufacturers, specification developers, relabelers/repackers, initial importers, and foreign exporters, must renew their registrations with the FDA on an annual basis. The renewal period is open from October 1 to December 31.
- Registration obligations: These establishments must list the devices they produce and the activities performed on those devices. Regardless of when the initial registration occurred, all facilities must ensure they submit, renew, update, or cancel their registrations in a timely manner.
- Potential consequences: Failure to comply with registration requirements can lead to import restrictions, civil or criminal actions. It is essential for companies and the facilities they source from to fulfill their registration obligations to avoid adverse consequences.
- FDA Solutions Group: The FDA Solutions Group offers facility registration services, helping companies identify their registration obligations, potential exemptions, and facilitating the registration process for foreign or domestic companies. They also provide service as a U.S. agent for foreign facilities. To learn more about registration during the current renewal period, contact Domenic Veneziano at (202) 734-3939.
Proper registration with the FDA is vital for foreign and domestic medical device facilities to continue their operations in the U.S. market. Failure to comply with registration requirements can result in import restrictions and legal consequences. It is crucial for companies and the facilities they work with to prioritize timely renewal and compliance to ensure the uninterrupted flow of medical devices into the U.S. market.
Source: https://www.strtrade.com/trade-news-resources/str-trade-report/trade-report/october/import-restrictions-possible-for-unregistered-medical-device-facilities
Importing 201
Did you know that U.S. Customs requires that importers have written policy and procedures for record-keeping and customs compliance? This course builds upon techniques presented in our U.S. Importing course and explains how to implement and strengthen your import controls. The course also describes what you should do to prepare for the eventuality of a CBP audit.
