Foreign Medical Device Manufacturer
US Agent services for foreign manufacturer
Foreign medical device manufacturer, exporter, specification developer and packers are required to appoint the U.S. Agent. We offer U.S. Agent services at competitive price for foreign companies and our fee is $ 299 per year. Click here to start.
Facility Registration and Device Listing Assistance
Foreign medical device manufacturer, exporter, specification developer and packers are required to register with the FDA. Our fee medical device registration assistance is $ 499 for foreign companies (includes annual U.S. Agent fee) and $ 199 for domestic companies.
510 K Assistance
Most of the class II and III are required to obtain pre-market clearance from the FDA. We offer consulting services for 510 K filing. Contact us for more information.
Medical device labeling
We offer labeling review services for medical devices . Contact us for more information.
Adverse Event Reporting
Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury.