For the medical device sector, "wholesale distributors" (as officially defined by the FDA) located in the United States are exempt from FDA establishment registration. However, if such U.S. distributor is the initial importer of foreign devices, then corresponding registration is required. In addition, foreign exporters distributing devices from outside the U.S. into the U.S. must register accordingly.
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 27-Oct-2023 07:50
From: Anne LeBlanc
Subject: Register as Distributor in US
Hi Anoop
Is this firm located in the US? And distributing products within the US? In one or more US states? And the products are drugs or medical devices? Wholesale or retail?
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Anne LeBlanc
United States
Original Message:
Sent: 27-Oct-2023 07:36
From: Anoop Paliwal
Subject: Register as Distributor in US
Hi,
what are the requirements to register a firm as a distributor in USA?
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Anoop Paliwal
Jaipur
India
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