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Export Services

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.


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FDA Medical Devices United States
FDA Medical Devices United States

Importing medical devices: where to Start

Companies that want to export medical devices to the United States must obtain FDA CDRH approvalImporters must comply with a set of FDA CDRH procedure...

Importing medical devices: where to Start

Classification

To obtain FDA CDRH approval, exporters and manufacturers must find what regulatory class the medical device belongs toExportUSA can help companies cla...

Classification

Class I medical devices

How to register a class I medical deviceExportUSA can help companies in the FDA CDRH registration procedure  ...

Class I medical devices

Class II and Class III medical devices

Registering Class II and Class III medical devicesExportUSA can help companies register medical devices with the FDA CDRH  ...

Class II and Class III medical devices