Class II and class III medical devices require more certifications and paperwork to be authorized by the FDA CDRH

Registering Class II and Class III medical devices

ExportUSA can help companies register medical devices with the FDA CDRH


Devices belonging to these regulatory classes are subject to more stringent FDA monitoring. This means their approval requires a higher number of authorizations and paperwork.

The initial investment required for FDA authorization of devices in these classes is very high. 

Please contact ExportUSA for more information.