Import to Export question

My company has conforming devices by the fda that we are the distributor. We also have the device cleared by Canada. We want to swap the IFU for the us devices and sell to Canada. No differences or changing in labeling, packaging etc. Only adding the IFU.

I am getting mixed advice that - If there is an upfront intent to import for export the FDA needs to be informed at the point of importation and becomes the manufacturer.

Any guidance would help.

Thanks

Jkc3usc12 said:

My company has conforming devices by the fda that we are the distributor. We also have the device cleared by Canada. We want to swap the IFU for the us devices and sell to Canada. No differences or changing in labeling, packaging etc. Only adding the IFU.

I am getting mixed advice that - If there is an upfront intent to import for export the FDA needs to be informed at the point of importation and becomes the manufacturer.

Any guidance would help.

Thanks

Click to expand...

@Jkc3usc12
As we know, FDA's jurisdiction primarily applies to devices intended for distribution within the United States, and hence when a product is imported with the intent to export the FDA typically requires notification at the point of importation. This is also to save you from double compliance work. In summary, I’d like to suggest 2 things:

1. If you are certain that you are importing to export, notify the intent to the FDA at the point of import. The FDA can then track the movement of these devices, ensuring transparency and compliance with regulations.
2. Ensure that your labeling is fully in compliance with the destination country’s regulations - in this case Canada.

This suggestion is based on the information provided here, if there are other details to this which can make this more intricate, you may want to do a proper consultation with a legal counsel or regulatory expert.

Best,
Parul Chansoria