On February 2, 2017, the U.S. Treasury Department’s Office of Foreign Assets Control (“OFAC”) amended the List of Medical Devices Requiring Specific Authorization (“List”), to update and clarify the scope of medical devices not authorized for export/reexport to Iran pursuant to the general license (“Ag/Med GL”) at section 560.530(a)(3)(i) of the Iranian Transactions and Sanctions Regulations, 31 C.F.R. Part 560 (“ITSR”).
In December 2016, OFAC had expanded the scope of the Ag/Med GL to generally authorize exports/reexports of all items meeting the ITSR’s definition of “medical devices,” except for those identified on the List. Previously, only items appearing on a “List of Medical Supplies” were eligible for the Ag/Med GL. As a result of the December 2016 change, only medical devices on the List require specific licenses for export to Iran, which are issued by OFAC pursuant to ITSR §560.530(a)(1).
The specific changes to the List are as follows:
- OFAC has deleted a “catch-all” Note stating that the Ag/Med GL does not cover items (i) within the scope of the Statement of Understanding – medical equipment at Supplement No. 3 to Part 744 of the Export Administration Regulations, 15 C.F.R. Part 730 et seq. (“EAR”) or (ii) excluded from an otherwise applicable Export Control Classification Number (“ECCN”) on the Commerce Control List, Part 774 of the EAR because they are designed or modified for medical equipment or medical purposes. Such items may now be exported under the Ag/Med GL without a specific license from OFAC, provided they do not appear on the List.
- With regard to medical imaging equipment, OFAC has deleted “endoscopy equipment incorporating lasers for tissue ablation” and “elastography equipment” from the List as items requiring a specific license. Such medical devices are now eligible for the Ag/Med GL.
- With regard to laboratory equipment, OFAC has deleted “centrifuges and centrifugal separators” from the List but added “balancing machines,” “motion simulators,” and “rate tables”; the latter three items were previously mentioned as examples in the “catch-all” Note that has since been deleted from the List (as further detailed above) and therefore continue to require specific licenses from OFAC for export/reexport to Iran.