A foreign establishment needs to identify a U.S. Agent as part of U.S. FDA registration. The U.S. Agent must confirm consent to act in that role.
U.S. Agent – Medical Devices
$350.00
Domestic and foreign owners or operators of places of business (establishments) that are involved in the production and distribution of medical devices intended for use in the United States are required to register annually with the FDA. Every entity involved in manufacturing, specification development, sterilization, repackaging, or initial importation must register annually. Any foreign establishment engaged in the manufacture, preparation, propagation, compounding, or processing of a device imported into the United States must identify a United States Agent (FDA U.S. Agent) for that establishment.
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We expect you to provide the following with your payment:
▪ Full company name, complete physical address (street, city, state, postal code, country)
▪ Name, telephone and email of CEO / Manager
▪ Products details
▪ Company activity: Manufacturer, Exporter, Importer, Distributor
▪ Related Application: Investigational Device Exemption (IDE), Premarket Notification 510(k), Premarket Approval (PMA), Annual Establishment Registration.
LIMITED
OFFER
$350.00
Per Medical Device Establishment.
