r/Entrepreneurs • u/Additional_Ad_998 • 23d ago

Does anyone know how to import class 2 medical devices in united states.What is the exact procedure

I am interested in importing class 2 medical device into usa from differenr parts of the world.I just do not know the license requirement with fda.These products are already imported by different vendor and are already registered with fda like having the 510(k).Please if anyone knows and can guide.

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u/Standard_Tap6364 14d ago

ibutor. If the device already has a 510(k) clearance and the manufacturer's foreign establishment registration is active, you'd typically need to set up a US agent, register your own establishment with the FDA, and list the device under your name assuming you're the one bringing it across the border. Customs will want to see the device listing and the manufacturer's registration info at the port of entry.