Bhupinder,
It depends on where the legal manufacturer address is located; if there is no physical address in the U.S. then you should consider an Initial Importer and must have a U.S. Agent. If there is no physical transfer of goods, then it should be considered if there is a financial transaction occurring and who would be conducting this on behalf or for the company.
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Richard Vincins RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 22-Jul-2020 17:34
From: Bhupinder Singh
Subject: Initial Importer
Yes, Commercial invoice for the software
Thanks,
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Bhupinder Singh
QA/RA Manager (RAC)
San Jose CA
United States
Original Message:
Sent: 22-Jul-2020 14:22
From: Ed Panek
Subject: Initial Importer
If there are goods or services provided taxes will be considered. Is ther a commercial invoice for the software?
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Edward Panek
VP, QA/RA
Blue Spark Technologies
Original Message:
Sent: 22-Jul-2020 11:53
From: Bhupinder Singh
Subject: Initial Importer
Hello RAPs Community,
I need your advice.
I am working for a Software as Medical Device and it is located in Asia. We have submitted our 510(K) to FDA and will get clearance soon. My question is that do we need to have an initial importer for a Software as Medical Device.
I think we don't need to have an initial importer as the device is SaMD.
Thanks,
Bhupinder Singh
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Bhupinder Singh
QA/RA Manager (RAC)
San Jose CA
United States
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