Publication of the List of Medical Devices Requiring Specific Authorization for the North Korea Sanctions Regulations
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 t...
List of medical devices excluded from North Korea Sanctions Regulations general license.
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.
This document and additional information concerning OFAC is available on OFAC's website (
https://ofac.treasury.gov).
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 § 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 (
https://ofac.treasury.gov) 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
Oxygen Generators
Pumps with flow rates of more than 1 liter/minute
Diagnostic Medical Imaging Equipment:
○ Gamma imaging equipment
○ Tactile Imaging equipment
○ Thermography equipment
Laboratory
Freeze-drying (lypophilizers) and spray-drying equipment
Fermenters, bioreactors, and chemostats
Crossflow (tangential) filtration systems and disposable filter cartridges
Biocontainment chambers and hoods, including isolators, biological safety cabinets, and laminar flow hoods
Aerosol inhalation equipment, including full-body, head-only, nose-only, and mask exposure systems
Decontamination showers
Laboratory glassware made from borosilicate glass, including reaction vessels, storage tanks, heat exchangers, and distillation and absorption columns
Autoclaves larger than 20 liters
Clinical laboratory water baths larger than 10 liters
Laboratory hot plates exceeding 1 square foot of heating surface
Freezers capable of reaching temperatures of −80 degrees Celsius
Laboratory shakers and incubator shakers
Carbon dioxide incubators
Circular dichroism spectrometers
Spectrometers and spectrophotometers not designed for clinical use
Fluorometers
Nuclear Magnetic Resonance Spectrometers
Polymerase Chain Reaction (PCR) machines
Differential Scanning Calorimeters
Chromatography Equipment
Fluorescence Microscopes
Confocal Microscopes
Cascade Impactors
Dynamic Light Scattering Equipment
Quasielectric Light Scattering Equipment
Full face mask respirators, including Powered Air Purifying Respirators (PAPR)
Decontamination systems using the following chemicals:
○ Vaporized hydrogen peroxide
○ Vaporized paraformaldehyde
○ Vaporized ethylene oxide
○ Isopropanol (99% purity)
High Efficiency Particulate Air (HEPA) Filtration Systems and HEPA filters
Use this for formal legal and research references to the published document.
91 FR 35400
Web Citation
Suggested Web Citation
Use this when citing the archival web version of the document.
“Publication of the List of Medical Devices Requiring Specific Authorization for the North Korea Sanctions Regulations,” thefederalregister.org (June 11, 2026), https://thefederalregister.org/documents/2026-11761/publication-of-the-list-of-medical-devices-requiring-specific-authorization-for-the-north-korea-sanctions-regulations.