How to Import Medical Devices into the United States


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Hi everyone,
I have a question :
How to import medical devices into US?
Can somebody briefly explain this

Thanks in advance.


Hello all,,
thanks for these info,
but what about the fact that ACE portal requests to choose a route for importation (rail, truck, air or ocean) when you need to fill-in the ace-import-manifest-documentation?
How to do when you have a software that is downloable or web-based?
Is it mandatory to register on ACE portal for a software? (to establish duty fees I imagine, and taxes)
or it is the final US distributors anyway who will invoice to the final customer who will pay the state taxes only?
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