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Who must pay an Establishment Registration Fee for medical device exports?
The following types of establishments are required to pay the establishment registration fee to the US FDA: Device manufacturers Contract sterilizers Contract manufacturers Single-use device reprocessors Specification developers Initial distributors are not required to pay the fee. The establishment registration fee for fiscal year 2008 is $1706. United States Agent for Foreign Establishments All foreign establishments must advise and notify FDA of the name, business name, address, phone number, and email address of their designated United States agent. Responsibilities of United States Agent.
U.S. Food and Drug Administration (FDA)
http://www.fda.gov
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