Exporting a medical device to Turkey

ScottK

ScottK

Not out of the crisis
Staff member
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#1
#1
We (in the USA) have been asked by a Turkish company to design and make a device that is identified as Class I in the US and EU for them as a contract manufacturer, and ship directly to Turkey.

What is our regulatory responsibility as far as Turkish requirements since the Turkish company is the legal manufacturer?
 
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john ambrose

#3
#3
I work with integrated circuits, so, I can tell you what we do for export. First, check what your system would be considered by the Bureau of Industry and Security and check to see if it is EAR 99 or has a Export Control Classification Number (ECCN). You can get the descriptions at bis.doc.gov.

Next, you want to do your best to make sure your customer in Turkey is not going to ship to an embargoed country. We have our potential customers sign a document placed on their letterhead making sure they know that certain countries cannot receive our products. There are exceptions that your product may fit into, but, this requires more paperwork and I am not familiar with that process.

The key thing for the BIS is you don't "self blind". Ask the questions, be happy with the answers, document, and it should go well for you.
 
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