On April 29, 2024 the Bureau of Industry and Security (BIS) issued a Final Rule in the Federal Register (effective immediately) revising the Russia and Belarus sanctions by adding a new license exception “MED” [EAR § 740.23] allowing for the export, re-export or transfer (in-country) of EAR99 medical devices and EAR99 parts, components, accessories, and attachments that are exclusively used with or in medical devices classified as EAR99 to Belarus, Russia as well as the occupied regions of Ukraine.
The term “medical devices” or “devices” as applicable to use of this license exception is defined by the language found in Section 201 of the Food, Drug and Cosmetic Act which specifically defines a “device” as:
An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—
(A) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,
(B) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or
(C) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
The term ‘‘device’’ does not include software functions excluded pursuant to section 360j(o) of this title.
It is important to note that use of license exception “MED” in conformance with the EAR places a verification burden on U.S. exporters. In addition to the standard Part 762 Recordkeeping requirements, exporters, re-exporters, and transferors of EAR99 medical devices (and related parts, components, accessories and attachments) must maintain a system of distribution that ensures that ‘‘medical devices’’ and ‘‘parts,’’ ‘‘components,’’ ‘‘accessories,’’ or ‘‘attachments’’ are not delivered to ‘‘proscribed persons’’ or entities engaged in the ‘‘production’’ of any product. Verification of the effectiveness of the distribution system may entail obtaining certain information from a consignee (e.g., obtaining affirmations or other documentation from a consignee, or performing periodic on-site spot-checks (e.g., conducting such verification by staff of the exporter, reexporter, or transferor; an internationally accredited auditing firm; or an internationally recognized nongovernmental humanitarian organization in Russia, Belarus, the temporarily occupied Crimea region of Ukraine, or the covered regions of Ukraine to conduct such verification).
For further information on this new license exception and guidance on whether your company may be eligible to use “MED” please contact TSI Global Consulting, LLC.
Image by Vlad Vasnetsov from Pixabay
