You need approval from the FDA [Food and Drug Administration] to import and sell medical devices in the United States of America.







Exporting and selling medical devices into the United States of America


If you want to sell medical devices in America, you need to obtain FDA approval for the device.



You need approval from the FDA [Food and Drug Administration] to import and sell medical devices in the United States of America.

Approval by the FDA Center for Devices and Rediological Health (CDRH) is required to export any kind of medical device to the United States. The procedure involves various steps: first of all it is necessary to determine whether the product is considered a “medical device.” If not, authorization will have to be asked to other FDA departments. 
 
The device must then be classified according to CDRH rules. Depending on the characteristics of the product, it may be placed in regulatory classes I, II or III.
 
Classification is very important, as requirements and regulation vary accordingly. For example, while  many class I products are eligible for exemptions, class III products require a more detailed set of documents. 
 
Preparation and presentation of the marketing application is the last and fundamental step to obtain FDA approval. 
 
It is worth noting that importers should make sure the device meets all labeling requirements as well. 
 
Finally, the company will register at the FDA and declare the products it intends to sell on the American market.