On November 2, 2015, the Department of the Treasury’s Office of Foreign Assets Control (OFAC) updated the List of Medical Supplies eligible for export or reexport to Iran under the general license set forth at Section 560.530(a)(3)(i) of the Iranian Transactions and Sanctions Regulations, 31 C.F.R. part 560 (ITSR). The updated list includes more than 60 additional items that are now eligible for export under the general license. This development provides greater opportunities for businesses to engage in permissible sales of medical equipment to Iran and should reduce the number of specific license applications required of medical device exporters.

Overview of Established OFAC Provisions

The ITSR prohibits U.S. persons from engaging in most transactions involving Iran, including exports to Iran of goods, technology or services. The ITSR also prohibit U.S.-owned or-controlled foreign subsidiaries from engaging in the same activity.  

OFAC authorizes companies to engage in transactions through general and specific licenses that the ITSR would otherwise prohibit. A general license authorizes certain categories of transactions in the regulations without the need to apply for a license. In instances where a general license does not exist, companies may file a written request to OFAC for a specific license. OFAC authorizes specific licenses on a case-by-case basis under certain limited situations and conditions.

In Section 560.530(a)(3)(i), the ITSR contains a general license for the export and reexport of medicine and medical supplies by a U.S. person or non-U.S. person to Iran if certain conditions are met.  One of the requirements of this general license is that any medical supplies be included on OFAC’s List of Medical Supplies.  

Updates to the List of Medical Supplies

OFAC has now included additional items in the List of Medical Supplies that may be exported or reexported under this general license. For instance, the list now includes certain items critical for the care of infants, such as infant warmers and neonatal intensive care devices used in maternity units. Additionally, the types of radiology equipment have been expanded to include the full suite of radiology technology, including MRI machines, X-ray machines, PET machines and similar equipment. Other items that are now on the list include:

  • assisted reproductive technology
  • cardiac pacemakers
  • dentures, crowns, molds and orthodontics
  • genetic testing products
  • hearing aids, accessories and components
  • implantable neurostimulators
  • manikins for medical and CPR training
  • medical pumps
  • orthopedic shoes, boots, etc.

This is just a small sample of the items that have been added to the List of Medical Supplies. Affected companies should consider reviewing all of the additions to the list to identify potential opportunities for medical sales to Iran. Companies may also want to consider whether certain specific licenses may no longer be required based on this development.