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Export Services

To obtain FDA CDRH approval, exporters and manufacturers must find what regulatory class the medical device belongs to

ExportUSA can help companies classify the medical device they intend to sell in America

 
If the product is indeed a medical device then classification is the first step towards obtaining CDRH approval. 
 
As previously mentioned, CDRH requirements for approval depend on the regulatory class of the device. 
 
Thus, it is extremely important that the device be classified properly. In order to identify the product's regulatory class one can make use of:
 
  1. Title 21 of the Code of Federal Regulation (CFR) parts 862-892. This is the main classification instrument as it lists over 1700 devices, specifying the class and requirements needed for their approval.
  2. Another method is to use the product code database.
 
ExportUSA offers consulting services to companies that need help determining their product's regulatory class. 
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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