Medical Device Exception to Russian Sanctions

Commerce Department’s Bureau of Industry and Security (BIS) published a final rule introducing the new License Exception MED, which enables delivery of humanitarian medical devices to the citizens of Russia, Belarus, and the temporarily occupied areas of Ukraine, consistent with the longstanding practice of authorizing transfers of life-saving medical devices to civilian populaces. At the same time, BIS is maintaining its sweeping restrictions on the export, reexport, or transfer (in-country) of items that could aid Russia’s brutal full-scale invasion of Ukraine.   

Specifically, License Exception MED authorizes certain exports, reexports, and transfers (in country) of the following items that are designated as EAR99 to Russia, Belarus, the temporarily occupied Crimea region of Ukraine, and the covered regions of Ukraine: low-level “medical devices” and related low-level “parts,” “components,” “accessories,” and “attachments” that are exclusively for use in or with “medical devices”.    

Bureau of Industry and Security (BIS) makes changes to the Russia and Belarus sanctions under the Export Administration Regulations (EAR) to add a new license exception for EAR99 medical devices and related parts, components, accessories, and attachments for use in or with medical devices that are destined for both countries and the temporarily occupied Crimea region of Ukraine, or the covered regions of Ukraine.

The purpose of this final rule is to authorize under a license exception certain exports, reexports, and transfers (in-country) of “medical devices” that are being regularly approved and that advance U.S. national security and foreign policy interests.

“This license exception only authorizes transfers of medical devices that are regularly approved through the licensing process,” said Assistant Secretary for Export Administration Thea D. Rozman Kendler

In addition, this final rule makes two corrections to the EAR related to Russia-related rules published in January, and March, 2024 by correcting an end-user control and adding a cross-reference correction.

The three sets of changes this final rule makes are described in section II as follows:

1. Addition of License Exception Medical Devices (MED);

2. Conforming changes to the EAR made in connection with the addition of License

   Exception MED; and

3. Correction to the March 21, 2024, final rule addressing EAR controls for certain

   Specially Designated Nationals (SDNs) and correction to the January 25, 2024,

   Russia sanctions final rule.