”Įased Restrictions on Medical Device Training and Maintenance and Repair 3 to Part 774 of the ” or (2) “excluded from an otherwise applicable Export Control Classification Number (ECCN) on the Commerce Control List of the EAR because it is medical equipment, or because it is designed or modified for medical equipment or medical purposes,” and therefore does “not qualify for exportation to Iran under section 560.530(a)(3)(i) of the. Importantly, in addition to the listed items, the List of Medical Devices Requiring Specific Authorization contains a note excluding from the general license any item: (1) “within the scope of the Statement of Understanding – medical equipment at Supplement No.
The conduct of related transactions is also authorized to the extent payment terms and financing are consistent with Section 560.532 however, military, intelligence and law enforcement end-users remain prohibited.Ĭompanies should review the special exclusion list to determine if their medical devices appear on that list since such items are not authorized by the general license and specific authorization from OFAC is required. The Final Rule expands the general license to authorize medical device manufacturers to export all medical devices that fall within the definition of “device” in Section 201 of the FFDCA and are designated as EAR99, or in the case of an item not subject to the Export Administration Regulations (EAR), would be designated EAR99 if located in the United States, provided that the item is not on the List of Medical Devices Requiring Specific Authorization. Since October 2012, OFAC has provided a general license for the exportation or reexportation of certain listed medical devices to Iran. On December 23, 2016, the Treasury Department’s Office of Foreign Assets Control (OFAC) issued a final rule amending the Iranian Transactions and Sanctions Regulations (ITSR) to expand the scope of permissible exports and reexports of medicine, medical devices and agricultural commodities to Iran and clarify the terms “Iranian origin” and “Iranian-origin goods.” The Final Rule significantly expands the scope of the general license for medical devices to Iran, authorizing manufacturers to export all medical devices satisfying the definition in the Federal Food, Drug, and Cosmetic Act (FFDCA) that are also designated EAR99 or would be if located in the United States with the exception of certain devices appearing on a special exclusion list.Įxpanded General License for Medical Devices
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