On April 26, 2024, the Department of Commerce’s Bureau of Industry and Security (BIS) published a final rule introducing the new License Exception MED that enables delivery of humanitarian medical devices to the citizens of Russia, Belarus, and the Crimea region of Ukraine, and the occupied regions of Donetsk and Luhansk. This license exception is an effort to formalize the U.S. policy of authorizing the export of medical devices to support civilian populaces. Specifically, License Exception MED authorizes certain exports, reexports, and transfers (in country) of the following items that are designated as EAR99: low-level medical devices and related low-level parts, components, accessories, and attachments that are exclusively for use in or with such medical devices. BIS notes that this license exception is intended to lessen the regulatory burden on both exporters and BIS on the export of medical devices “that are being regularly approved and that advance U.S. national security and foreign policy interests.” This final rule is effective as of April 29, 2024.
To be eligible for export under License Exception MED, the medical device must be an item subject to the EAR that is not described on the Commerce Control List (CCL) in Supplement No. 1 to part 774 and, thus, is designated as EAR99. The license exception does not authorize exports of medical devices to any prohibited persons/parties (such as persons on the Entity List or military end-users), to any “production” “facilities,” or when there is knowledge that the medical device, parts, components, accessories, and attachments are intended to develop or produce items. Further, exporters making use of this license exception must maintain a verification system to ensure such medical devices are not delivered to prohibited persons/parties or those engaged in production of any product. Such verification may include obtaining certain information (such as affirmations) from a consignee or conducting on-site spot-checks (including through an internationally accredited auditing firm or internationally recognized NGO).
The use of License Exception MED is nuanced and must be reviewed carefully prior to relying upon it for any export, reexport, or transfer (in-country) to Russia, Belarus, and the Crimea region of Ukraine, and the occupied regions of Donetsk and Luhansk. While the license exception does authorize transactions involving items designated as EAR99 that would otherwise require a license pursuant to various EAR controls under 15 C.F.R. §§ 746.5, 746.6, or 746.10, it specifically does not exempt an exporter from any license requirements imposed under § 746.8 or any other EAR license requirements.