Addition to List of Medical Devices Requiring Specific Authorization
OFAC has clarified and added to the list of medical devices requiring specific licenses. These medical devices formerly were authorized under General License 31 C.F.R. 560.530(a)(3) (Authorizing the Exportation of or Reexportation of Medicine and Medical Devices to Iran) and broadly permitted for export/reexport to Iran. Exporters must apply to receive a specific license from OFAC for the medical supplies and equipment added to this list.
The US-Iran Chamber of Commerce can advise you about the license application process required under U.S. laws and regulations. For your specific transactional needs, the Chamber may provide referrals to specialized sanctions or OFAC attorneys. For further guidance, please contact us at info@USIRCC.org.
The additions to this list are as follows:
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
- 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
- Fourier Transformation Infrared (FTIR) Systems
- Balancing machines
- Motion simulators
- Rate tables