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OFAC Provides North Korea Medical Devices List

Lindsay Bernsen Wardlaw
2 min read

Exporters are no longer reliant on a similar list from the Iran sanctions program.

On June 11, 2026, OFAC released a list of the medical devices that do not require a specific license to be exported to North Korea (i.e., items that are covered by the Feb. 2024 general license incorporated directly into the North Korea Sanctions Regulations at 31 C.F.R. § 510.521, as long as they also meet the FDA’s definition of a “device”).

You might think this is old news. But it is interesting because the North Korea general license for agricultural commodities, medicine, and medical devices always promised that this particular list would be available on OFAC’s website. It was not. Instead, exporters of medical devices had to infer coverage based on the 2017 list of items that do not require a specific license to be exported to Iran.

There are two upshots:

  1. As it turns out, the North Korea list is nearly identical to the list of medical devices covered by the comparable general license for Iran (with the North Korea list actually adding spectrometers to the spectrophotometers already covered)–so anyone who acted in reliance on the Iran list can likely now breathe a sigh of relief. (Of course, I don’t know your specific situation. Talk to your counsel if you need analysis.)
  2. This publication is actually very gratifying. It shows OFAC’s intention to continue improving its communication with industry. Exporters should not have to guess or make assumptions about what law applies to their products. While practitioners often assume concepts from one sanctions program apply to another unless the text states otherwise, the clearer OFAC is on these issues, the better compliance with OFAC’s intentions will be.
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Disclaimer: Our practice focuses on U.S. trade regulations (and related federal regulations, like ICTS, as they emerge). We do not advise on state laws or on the laws of any other country.

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