If i do not want to be an initial importer should i register with FDA?

I

Irina85

Registered
#1
#1
Good day, could you please advice in the following question:
I want to sell medical device class II in US on marketplace. I have manufacturer with FDA and FDA 510K. I see the two variations to do this:
1. to stay an initial importer of this device. In this way i should registered on FDA, pay fee and find logistic company to deliver the product from China to US
2. to stay only seller and to find the agent who become an initial importer for my product and deliver it in US. For this way, should i get FDA approval to sell medical device? Or i need any other permissions to sell medical device in US? Do you know any verified agent who can be an initial importer and supplier for my product?
will be very appriciate for any feedback
 
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