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Medical Devices and Medicine
The revised GLs include the following beneficial changes for medical device and pharmaceutical manufacturers:
• OFAC has changed its approach from a positive list of medical devices that are eligible for the GL to a negative list approach; that is, most medical devices are now eligible for the GL unless they are identified on the new List of Medical Devices Requiring Specific Authorization, in which case a company must apply for and receive a specific license to sell such devices and engage in related activities;
o OFAC has provided informal guidance confirming that under the revised GL, all devices that were previously set forth on the List of Medical Supplies remain eligible for the GL, and that the agency did not intend to narrow the scope of items authorized for sale pursuant...
1) BACKGROUND RE: IMPORTATION OF TSRA-RELATED ITEMS FROM IRAN
See FR Notice Explaining Certain TSRA-Related Amendments to the ITSR; Change to Definition of Iranian-origin Goods (81 FR 94254, Dec. 23, 2016), with OFAC providing a broad overview of the evolution of 560.530 from 2012 up to the date of the amendments that are the subject of the guidance reported here by Hogan Lovells.
Hogan Lovells reports that:
"OFAC has informally confirmed that [560.530] extends to re-importation of non-U.S. origin medical devices if such devices would be classified as EAR99, as well as the importation of EAR99 U.S.-origin medical devices into, for example, the E.U. affiliate of a U.S. company for servicing or repairs, and that U.S. persons may...