The broken or non-operational replacement parts that are being replaced are promptly exported, reexported, or otherwise provided to a non-Iranian entity located outside of Iran selected by the replacement part supplier and.The number of replacement parts stored in Iran cannot exceed the number of corresponding operational parts currently in use in relevant medical devices in Iran.The replacement parts must be exported to replace a broken or non-operational component of a medical device that was legally exported or the exportation or reexportation of such replacement parts is necessary and incident to the proper preventive maintenance of such medical device.The replacement parts must be EAR99 (or if non-US origin, EAR99 if they were located in the US).
#Ofac general license iran medical license#
The conditions of this general license are as follows: OFAC expanded the general license for replacement parts for medical devices exported under general or specific license. The training cannot be provided to any military, intelligence, or law enforcement entity, or any official or agent thereof.Įxpanded General License for Medical Device Replacement Parts.Any technology released in the training must be EAR99 and.Payment terms and financing have to meet the standard requirements of 31 C.F.R.3, medical equipment are " to the Government of Iran, to any individual or entity in Iran, or to persons in a third country purchasing such goods specifically for resale to any of the foregoing." The conditions of this general license are as follows: The first set of EAR items excluded from the General License is medical equipment at Supplement No. Items "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.".3 to Part 774 of the Export Administration Regulations (EAR) " and Items "within the scope of the Statement of Understanding - medical equipment at Supplement No.However, the exclusion list also contains a mysterious note excluding two other sets of items based on their status under the Export Administration Regulations (the "EAR"), which we discuss in detail in the paragraphs below:.For example, the list includes the following items: oxygen generators, pumps with flow rates of more than 1 liter/minute, fermenters, bioreactors and chemostats, and autoclaves larger than 20 liters. Most of the items on the exclusion list are described in technical terms that hopefully will be clear to medical device manufacturers.All EAR99 medical devices qualify for the general license unless they appear on the exclusion list.The new general license works as follows: On December 23, 2016, OFAC expanded the general license to authorize medical device manufacturers to export from the US to Iran all EAR99 medical devices, or to export from other countries to Iran non-US medical devices that would be EAR99 if they were in the US, provided the medical devices in question do not appear on a special exclusion list, the List of Medical Devices Requiring Specific Authorization (effective December 23, 2016).Ĭompanies need to review the new exclusion list carefully: if their medical devices appear on that list, the general license is not available and they need to continue to apply for specific licenses. OFAC has provided a general license for the exportation or reexportation of certain listed medical devices to Iran, 31 C.F.R. Revised General License for Medical Devices to Iran We discuss both of these major changes below.Ī. OFAC also narrowed the list of excluded agricultural products, authorizing exports of shrimp and shrimp eggs to Iran under the general license.Įxporters will need to review the new regulations carefully, first to see if their medical devices qualify for the new broader general license, but also to see if they can now support their products more fully in Iran.
#Ofac general license iran medical full#
The full Federal Register notice is available here. OFAC also issued general licenses that provide much greater flexibility for training on the devices, as well as maintenance and repair. On Decemin pre-holiday spirit, the Treasury Department’s Office of Foreign Asset Control sent US medical device manufacturers and their overseas subsidiaries and affiliates a present last week in the form of a revised General License for medical devices to Iran. OFAC Expands General Licenses to Export Medical Devices, and Associated Services, to Iran OFAC Also Redefines “Iranian-Origin” Goods Eliminating Its Unintended Capture of Goods Just Passing Through Iranian Ports and Airports
0 kommentar(er)
