Rule2026-11761
Publication of the List of Medical Devices Requiring Specific Authorization for the North Korea Sanctions Regulations
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
June 11, 2026
Effective
June 11, 2026
Issuing agencies
Treasury DepartmentForeign Assets Control Office
Abstract
The Department of the Treasury's Office of Foreign Assets Control (OFAC) is publishing a list of medical devices that may not be exported or reexported to North Korea pursuant to the general license authorizing the exportation or reexportation to North Korea of certain agricultural commodities, medicine, medical devices, and replacement parts and components. The exportation or re-exportation of these excluded medical devices to North Korea requires specific authorization from OFAC.
Full Text
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<title>Federal Register, Volume 91 Issue 112 (Thursday, June 11, 2026)</title>
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[Federal Register Volume 91, Number 112 (Thursday, June 11, 2026)]
[Rules and Regulations]
[Page 35400]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2026-11761]
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DEPARTMENT OF THE TREASURY
Office of Foreign Assets Control
31 CFR Part 510
Publication of the List of Medical Devices Requiring Specific
Authorization for the North Korea Sanctions Regulations
AGENCY: Office of Foreign Assets Control, Treasury.
ACTION: List of medical devices excluded from North Korea Sanctions
Regulations general license.
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SUMMARY: The Department of the Treasury's Office of Foreign Assets
Control (OFAC) is publishing a list of medical devices that may not be
exported or reexported to North Korea pursuant to the general license
authorizing the exportation or reexportation to North Korea of certain
agricultural commodities, medicine, medical devices, and replacement
parts and components. The exportation or re-exportation of these
excluded medical devices to North Korea requires specific authorization
from OFAC.
DATES: This list is effective June 11, 2026.
FOR FURTHER INFORMATION CONTACT: OFAC: Assistant Director for
Regulatory Affairs, 202-622-4855; or <a href="https://ofac.treasury.gov/">https://ofac.treasury.gov/</a>contact-
ofac.
SUPPLEMENTARY INFORMATION:
Electronic Availability
This document and additional information concerning OFAC is
available on OFAC's website (<a href="https://ofac.treasury.gov">https://ofac.treasury.gov</a>).
Background
On February 16, 2024, OFAC adopted a final rule (89 FR 12233)
amending the North Korea Sanctions Regulations, 31 CFR part 510 (the
``Regulations''), to, among other things, add a new general license at
Sec. 510.521 authorizing the exportation or reexportation to North
Korea of certain agricultural commodities, medicine, medical devices,
and replacement parts and components that are not subject to the Export
Administration Regulations, 15 CFR parts 730 through 774. Section
510.521(b)(3) defines a medical device to mean an item that (i) falls
within the definition of ``device'' in section 201 of the Federal Food,
Drug, and Cosmetic Act (21 U.S.C. 321), and (ii) is not on the List of
Medical Devices Requiring Specific Authorization (the ``List''), as
maintained on OFAC's website (<a href="https://ofac.treasury.gov">https://ofac.treasury.gov</a>) on the North
Korea Sanctions page. OFAC is now publishing the List in the Federal
Register and on its website.
The text of the List is provided below.
List of Medical Devices Requiring Specific Authorization (June 11,
2026)
The list below comprises the List of Medical Devices Requiring
Specific Authorization as identified in 31 CFR 510.521(b)(3)(ii).
General Medical Supplies and Equipment
<bullet> Oxygen Generators
<bullet> Pumps with flow rates of more than 1 liter/minute
<bullet> Diagnostic Medical Imaging Equipment:
[cir] Gamma imaging equipment
[cir] Tactile Imaging equipment
[cir] Thermography equipment
Laboratory
<bullet> Freeze-drying (lypophilizers) and spray-drying equipment
<bullet> Fermenters, bioreactors, and chemostats
<bullet> Crossflow (tangential) filtration systems and disposable
filter cartridges
<bullet> Biocontainment chambers and hoods, including isolators,
biological safety cabinets, and laminar flow hoods
<bullet> Aerosol inhalation equipment, including full-body, head-only,
nose-only, and mask exposure systems
<bullet> Decontamination showers
<bullet> Laboratory glassware made from borosilicate glass, including
reaction vessels, storage tanks, heat exchangers, and distillation and
absorption columns
<bullet> Autoclaves larger than 20 liters
<bullet> Clinical laboratory water baths larger than 10 liters
<bullet> Laboratory hot plates exceeding 1 square foot of heating
surface
<bullet> Freezers capable of reaching temperatures of -80 degrees
Celsius
<bullet> Laboratory shakers and incubator shakers
<bullet> Carbon dioxide incubators
<bullet> Circular dichroism spectrometers
<bullet> Spectrometers and spectrophotometers not designed for clinical
use
<bullet> Fluorometers
<bullet> Nuclear Magnetic Resonance Spectrometers
<bullet> Polymerase Chain Reaction (PCR) machines
<bullet> Differential Scanning Calorimeters
<bullet> Chromatography Equipment
<bullet> Fluorescence Microscopes
<bullet> Confocal Microscopes
<bullet> Cascade Impactors
<bullet> Dynamic Light Scattering Equipment
<bullet> Quasielectric Light Scattering Equipment
<bullet> Full face mask respirators, including Powered Air Purifying
Respirators (PAPR)
<bullet> Decontamination systems using the following chemicals:
[cir] Vaporized hydrogen peroxide
[cir] Vaporized paraformaldehyde
[cir] Vaporized ethylene oxide
[cir] Isopropanol (99% purity)
<bullet> High Efficiency Particulate Air (HEPA) Filtration Systems and
HEPA filters
<bullet> Fourier Transformation Infrared (FTIR) Systems
<bullet> Balancing machines
<bullet> Motion simulators
<bullet> Rate tables
<bullet> Fluorescence-activated cell sorters (FACS)
Bradley T. Smith,
Director, Office of Foreign Assets Control.
[FR Doc. 2026-11761 Filed 6-10-26; 8:45 am]
BILLING CODE 4810-AL-P
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