U.S. Export of Medical Device to Iran

Greetings,

With the recent U.S. amendment to the Iranian Transactions and Sanctions Regulations (ITSR) relating to the exportation of medical devices to Iran, my company would like to export an IVD product to a customer who contacted us a few weeks ago.

Our product does not fall on the List of Medical Devices Requiring Specific Authorization (effective 2016-12-23). Therefore, if my interpretation is correct we do not need to apply for a specific license from the Office of Foreign Assets Control (OFAC) as our device falls under general license.

However, is anyone aware of additional steps we must take in order to export our product? Do we need a notarized, certification letter from our company to the Iranian Ministry of Health accompanying the product? Or, should such a letter, if required, be sent to the Iranian Ministry of Health directly?

Please advise.

Regards, Tonia

I doubt how man Iranians there are in this forum.

Because of the instability, on the Iranian side I would direct the questions to the client or local distributor. And the US side, it's to double check your assumption with the OFAC.

Shimon

At this time I doubt there is an answer considering the extreme political changes in the US.

If anyone does have any thoughts on this by all means do so.

I would also double check your assumption about OFAC with your attorney. Running afoul of these regulations could be really tragic, so it could be worth it to make sure you're on the right path with respect to these specific and general licenses.

I would also check with your attorney on what you need to do both on the ground in Iran to make sure your devices may be sold, and then again here in the US to make sure you get paid. What you want to avoid is your bank freezing your accounts because the payment for your product came from a bank that's on the blacklist.