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 Fiscal Agent Request Form20190325 DOCX 2019

2019-2025 Form

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morning if you are just waking up in the U.S you can go back to bed this is not about anything that you need if you're in the U.S this is specifically for companies that are outside the US if you're a medical device manufacturer that's in Europe when you won't import products into the U.S one of the things that you need to do is you need to have a U.S agent a lot of people aren't familiar with what the U.S agent does what what does this person responsible for in Europe we have an EU authorized representative we have a UK responsible person we have a Swiss responsible person this is very similar to those roles you need a person that's physically located in the U.S that will be the person that the FDA can contact if they can't get a hold of the manufacturer so this would apply to anybody that's registered on the FDA website if you're a manufacturer if you're a contract manufacturer if you're a specifi

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