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Does anyone know the requirements to sell FDA approved products (made in China) in to the US?

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Does anyone know the requirements to sell FDA approved products (made in China) in to the US? I’m in the UK.

As I understand it the following must happen:

– Manufacturer must register/list with the FDA – fees for them
– Exporter must register/list with the FDA – fees for us
– Importer must register/list with the FDA – fees for us

I’m not sure if using a courier in the chain removes any of the requirement for fees or registration.

I must say I’m a bit lost with this and would appreciate someone explaining it if they have some experience.

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as I think of your situation, it reminded me of my client ( I am a china business consultant by trade). I have to say that it is a red flag if your supplier does not have FDA approval already. It also means that they never export it to USA. There must be a reason.

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The information sounds right. My client who tried to import nutritional products using animal protein learned that his product requires additional documents by department of agriculture.

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Hi. It’s not so much the registration that concerns me it’s the apparent $3-4000 fee to pay. I really hope I’ve got all this completely wrong. Hopefully, I can find a forwarder acting as IOR who has all this registration etc. I don’t know at all.

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Correct, as the seller you have to register and pay the annual FDA fee, plus register for 510k approval which is another 15-50k.

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