On April 25, 2024, the US Department of Commerce’s Bureau of Industry and Security (BIS) issued a new license exception for the export, reexport, or transfer (in-country) of EAR99 medical devices and related items for use in or with medical devices that are destined for Russia, Belarus, Crimea or certain other parts of Ukraine. This new license exception went into effect on April 29, 2024. The purpose of the license exception is to allow certain transactions that BIS generally had been approving on a case-by-case basis under its more permissive license application review policies for humanitarian-related transactions.

The new license exception, called License Exception Medical Devices (MED), was added under § 740.23 of the EAR. MED authorizes the export, reexport, or transfer (in-country) of “medical devices” designated as EAR99 to or within Russia, Belarus, the temporarily occupied Crimea region of Ukraine, or the covered regions of Ukraine (which include the Donetsk and Luhansk People’s Republics), subject to certain terms and conditions. The license exception also covers “parts,” “components,” “accessories,” and “attachments” designated as EAR99 that are exclusively for use in or with EAR99 “medical devices.” Under the EAR, “medical devices” are defined consistent with the definition of  “devices” under the Federal Food, Drug, and Cosmetic Act¹ and include products such as medical supplies, instruments, equipment, equipped ambulances, institutional washing machines for sterilization, and vehicles with medical testing equipment.

The new MED license exception does not authorize any transactions involving “proscribed persons,” “production” facilities, or items intended to develop or produce other items. The license exception also requires exporters, reexporters, and transferors to maintain a system of distribution that ensures that the items are not delivered to unauthorized end users or end uses and to keep records of verification for five years. To verify the effectiveness of distribution systems, the exception notes that exporters may need to acquire an affirmation from the consignee that the use and disposition of “medical devices” received under the license exception remain consistent with the exception’s terms, or to conduct periodic on-site spot-checks either directly, or via internationally accredited auditing firms or internationally recognized non-governmental humanitarian organizations. This verification provision formalizes BIS’s prior practice of requiring exporters to provide a certification regarding the end use and user of “medical devices” before granting license applications for their export, reexport, and transfer (in-country) to or within Russia, Belarus, Crimea, or the covered regions of Ukraine.

The rule announcing the new license exception also makes conforming changes to the EAR where relevant. Specifically, the rule revises §§ 746.5, 746.6, and 746.10 of the EAR, which outline license requirements applicable to Russia, Belarus, Crimea, and the covered regions of Ukraine, to include License Exception MED as an available exception that may overcome the license requirements in certain situations. The rule also revises § 762.2 of the EAR, which lists the records that must be retained under the EAR, to add a reference to § 740.23’s recordkeeping requirement.

Entities engaged in sales of medical devices to Russia, Belarus, Crimea, and the covered regions of Ukraine, should review their transactions to determine whether they meet the conditions of License Exception MED. Additionally, such entities should review their compliance procedures to ensure they meet the verification and recordkeeping requirements applicable under the license exception, if they intend to utilize it.

1. 21 U.S.C. 321.↩