BIS Drafting FAQ on New License Exception for Medical Devices to Russia

The Bureau of Industry and Security is developing a list of frequently asked questions (FAQ) to explain its new license exception authorizing certain exports of medical devices to Russia, it was revealed at an April 30 meeting of the agency’s Regulations and Procedures Technical Advisory Committee (RPTAC).

The FAQ could address a concern raised during the RPTAC meeting that the exception applies to EAR99-designated “medical devices” and related “parts,” “components,” “accessories” and “attachments” but does not specifically mention "consummables," such as fluids and vials, that are often essential to using medical equipment.

The FAQ is also expected to provide guidance on ensuring compliance with the terms and conditions of the license exception, as strained U.S.-Russia relations could make on-the-ground verification challenging.

BIS created the license exception in a final rule it released April 25 (see 2404250058). The exception, which is intended to facilitate transfers of life-saving medical devices to civilians, applies to Belarus and “the temporarily occupied areas of Ukraine,” in addition to Russia.