Federal Register #2026-11761

OFAC List of Medical Devices Requiring Authorization for Export to North Korea

This notice from the Department of the Treasury's Office of Foreign Assets Control (OFAC) outlines medical devices and laboratory equipment that require specific authorization for export or reexport to North Korea under the North Korea Sanctions Regulations. - Government Buyer: - Department of the Treasury - Office of Foreign Assets Control (OFAC) - Products/Services Listed: - Medical devices and laboratory equipment, including: - Oxygen generators - Pumps with flow rates over 1 liter/minute - Gamma, tactile, and thermography imaging equipment - Freeze-drying and spray-drying equipment - Fermenters, bioreactors, chemostats - Filtration systems and disposable filter cartridges - Biocontainment chambers and hoods - Aerosol inhalation equipment - Decontamination showers - Borosilicate glass laboratory glassware - Autoclaves (over 20 liters) - Clinical laboratory water baths (over 10 liters) - Laboratory hot plates (over 1 sq ft) - Freezers capable of -80°C - Laboratory shakers and incubator shakers - Carbon dioxide incubators - Spectrometers (including circular dichroism, NMR, FTIR) - PCR machines - Chromatography equipment - Fluorescence and confocal microscopes - Cascade impactors - Light scattering equipment - Full face mask respirators (including PAPRs) - Decontamination systems using specific chemicals - HEPA filtration systems - Balancing machines, motion simulators, rate tables - Fluorescence-activated cell sorters (FACS) - Unique/Notable Requirements: - These items are excluded from the general license and require specific OFAC authorization for export to North Korea - No OEMs, vendors, part numbers, or purchase quantities are specified - This is a regulatory notice, not a procurement or award announcement

Description

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 under the general license authorizing certain exports. These medical devices require specific authorization from OFAC for exportation or reexportation to North Korea. The list is effective June 11, 2026, and is part of the North Korea Sanctions Regulations. This action aims to regulate the export of sensitive medical devices to North Korea to comply with sanctions.

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