The U.S. Department of Commerce’s Bureau of Industry and Security (BIS) has amended the Export Administration Regulations (EAR) to include a new license exception for Medical Devices “MED”[i]. This exception allows U.S. companies to export, reexport, or transfer certain medical devices classified as EAR99 to Russia, Belarus, the temporarily occupied Crimea region of Ukraine, and certain other regions of Ukraine, easing the movement of these devices.

By introducing the new License Exception “MED,” BIS aims to facilitate legitimate exports of medical devices while strengthening the reporting process to ensure that these devices are carefully tracked and comply with U.S. export controls. 

Medical devices designated EAR99 are generally exempt from BIS licensing[ii]. However, in recent years, further sanctions against Russia made several medical device items subject to BIS licensure[iii]. As a result, exporters of affected medical devices were forced to apply for and wait to receive a BIS license, which could often take several months to complete.

Thanks to the new License exemption “MED,” US companies are authorized (subject to certain terms and conditions) to export, reexport, and transfer (in-country) medical devices that BIS has generally been approving under the licensing application review policies.

Key Components of the Amendment

• Scope of License Exception MED: This license exception covers medical devices and related parts, components, accessories, and attachments exclusively used in or with EAR99-classified medical devices.

• Restrictions and Compliance: License Exception MED does not apply to exports involving restricted persons, including military end-users, or to production facilities. Exporters must verify that the goods’ end use aligns with the license’s conditions and keep records of these verifications. 

• Reporting Requirements: Effective April 29, 2024, exporters using License Exception “MED” must follow the specific reporting requirements set out by the BIS, which include the correct usage of the new License Code C69 (MED) in the Automated Export System (AES). This ensures that the exports are appropriately tracked and comply with the EAR​.

Questions about License Exemption Code MED and export compliance can be sent to Tradecompliance@marken.com.

[i] Amendment to Existing Controls on Russia and Belarus Under the Export Administration Regulations (EAR) Adding New License Exception Medical Devices (MED) https://www.federalregister.gov/documents/2024/04/29/2024-09076/amendment-to-existing-controls-on-russia-and-belarus-under-the-export-administration-regulations-ear

[ii] BUREAU OF INDUSTRY AND SECURITY FREQUENTLY ASKED QUESTIONS APPLICABLE LICENSE REQUIREMENTS CURRENT AS OF MAY 2, 2022 https://www.bis.doc.gov/index.php/documents/policy-guidance/2974-2022-05-02-bis-faq-applicable-license-requirements/file

[ii] Supplement No. 4 to Part 746—Russian and Belarusian Industry Sector Sanctions Pursuant to § 746.5(a)(1)(ii). https://www.ecfr.gov/current/title-15/subtitle-B/chapter-VII/subchapter-C/part-746/appendix-Supplement%20No.%204%20to%20Part%20746