Selling Medical Devices in Puerto Rico

[MariaHj]

Hi Everyone,

If a medical device is listed in the U.S/FDA can they be sold in Puerto Rico, or are there any additional requirements to register the devices for sale in Puerto Rico?

Thanks

 

[Sidney Vianna]

When medical devices are sold domestically, can they be sold in Puerto Rico?

 

[craiglab]

FDA jurisdiction covers PR and there are no additional requirements. There is a labeling exception in 801 that allows for 100% Spanish labeling if the device is sold solely in PR, if that is desired.

 

[MariaHj]

Thanks Sidney Vianna and Craiglab