Initial Importer of Medical Device

Importer registration

Medical device importers are required to register with the FDA. We can help medical device importer to register with the FDA, our fee for registration assistance is $ 299. Click here for more information.

Adverse Event Reporting

Importers are required to report to the FDA and the manufacturer when they learn that one of their devices may have caused or contributed to a death or serious injury.

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.