This page provides information for use by persons who wish to use the expedited export license application procedure of the Treasury Department, Office of Foreign Assets Control (OFAC), for exports of agricultural commodities, medicines or medical devices to Iran or Northern Sudan under the Trade Sanctions Reform and Export Enhancement Act of 2000 (www.treasury.gov/resource-center/sanctions/Programs/Pages/tsra.aspx). Note that medicines and medical devices are not eligible for the expedited procedures to Cuba.
This page includes a list of basic medical devices that have been determined to be EAR99 and for which license applications to export to Iran or Northern Sudan may be submitted to OFAC without an accompanying commodity classification from the Department of Commerce, Bureau of Industry and Security. This page also includes guidance for EAR99 medicines and agricultural commodities.
From time-to-time, the contents of this page may change because the technical characteristics of items on it may change, items might be reclassified by BIS, or the Commerce Control List might be amended to include some of these items. Before filing a license application with OFAC, check the current page. “Medicines" and "medical devices" are defined in Part 772 of the Export Administration Regulations.
UPDATE: On October 12, 2011, OFAC amended the Sudanese Sanctions Regulations, 31 CFR Part 538, and the Iranian Transactions Regulations, 31 CFR part 560, by issuing general licenses that authorize the exportation or reexportation of most food items to individuals and entities in an area of Sudan other than the Specified Areas of Sudan and in Iran. Certain specified food items, as well as exports to certain persons, requiring a greater level of scrutiny are excluded from the general licenses. These general licenses do not authorize the export of food items to military or law enforcement purchasers or importers. No other agricultural commodities are covered by these general licenses. For complete details see: http://www.gpo.gov/fdsys/pkg/FR-2011-10-12/pdf/2011-26175.pdf.
Medical devices: For purposes of the EAR, medical devices are “devices” as defined in section 201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) including medical supplies, instruments, equipment, equipped ambulances, institutional washing machines for sterilization, and vehicles with medical testing equipment.
Exporter Guidance: BIS and OFAC encourage self-classification of obviously EAR99 items. Please use the list below for the types of medical devices that are EAR99. For medical devices that have an electronic component, OFAC requires a Commodity Classification (CCAT) from BIS. When submitting a CCAT, include the model name and number, and please reference any former CCATs by the G#. Please note that only six items can be listed on each CCAT.
|Ablation devices and accessories, radio frequency|
|Autoclave for medical instrument sterilization|
|AED, Automated External Defibrillator|
|Bags, I.V. ( drainage, biohazard)|
|Balloon (extractor, retrieval)|
|Bandages (all)/Gauze/ First aid dressings|
|Bath cubes, therapy|
|Biohazard waste plastic bags|
|Blood collecting tubes|
|Blood management machines, auto transfusion|
|Bone graft matrix|
|Boots, lined for heat relief|
|Bottles, specimen, prescription|
|Cardiac Monitors, implantable or external|
|Cardiac defibrillator, external and internal|
|Cardiopulmonary Oxygenation systems, devices and monitors|
|Cervical collar, soft|
|Cervical fusion kit|
|Coagulation machines, Cardiovascular and Vascular surgery|
|Contact Lenses, corrective|
|CPAP (continuous positive airway pressure) systems and all components|
|Defibrillator and all components|
|Dental composites, dentures, crowns, etc|
|Dental instruments, all (e.g., pliers, scrapers, etc)|
|Dental Implants (& screws & abutments)|
|Electrocardiogram (ECG or EKG), cart and accessories|
|Flowmeters, oxygen & air pressure|
|Flow cytometry accessories, reagents and components|
|Gloves, medical exam, surgical|
|Grafts, peripheral bypass|
|Heart positioners, surgical revascularization|
|Heart valves , surgical, transcatheter (non-surgical)|
|Image- guiding surgery products, ear, nose and throat|
|Inflation devices, interventional|
|Infusion (blood) pumps|
|Lift, patient chair|
|Liner, mitts and boot for therapeutic pain relief|
|Manikin, medical training|
|Medicines, prescription and over the counter except for vaccines, immunotoxins, and products containing toxins|
|X-ray Medical lights|
|Medicine cup holder|
|Meter, portable (temperature/pH)|
|Monitors, all patient|
|Monitor, glucose management|
|Naso gastric tubes|
|Neonatal equipment and all components|
|Ophthalmology instruments (keratotome, retractors,speculums, etc)|
|Orthopedic plates/screws, fixators, implants|
|Ostomy equipment (e.g., tubes, adhesives, cleansers, bottle)|
|Oxygen apparatus, all|
|Padding, under cast|
|Pads, elbow & foot|
|Parts and accessories for medical imaging devices (e.g., x-ray, ultrasound, CT or MRI scanners) that do not contain nuclear or chemical components|
|Patient gowns, underpads, under garments|
|Placement sets, I.V.|
|Pumps, medical blood management, insulin, etc|
|Refrigerator, compartmental for morgues|
|Resuscitation devices, all|
|Sterilization supplies, roll tube, tape, etc|
|Surgical supplies (drapes, dressings, foot covers, gowns, masks, procedure packs, scrub brushes)|
|Surgical instruments - all (no electronic components)|
|Suture removal kits|
|Tents, pediatric, aerosol, & mist|
|Thermometers, mercury for measuring human body temperature|
|Tissue Stabilizer, surgical revascularization|
|Trays for holding medical instruments. Includes accessories (i.e., tray lids and tray mats|
|Ultrasound machines and accessories|
|Urine test strip|
|Urine collection bags|
|Urine collection bottle|
|Wash basin, plastic|
|Whirlpool, hydrotherapy designed for burn treatment|
|Wound drainage tubes|
|Wrist band, patient I.D.|
Medicines: Medicines means “drug” as defined in section 201 of the Federal Food, Drug and Cosmetic Act (21 U.S.C. 321). For purposes of the EAR, medicines includes prescription and over the counter medicines for humans and animals. Note that certain medicines, such as vaccines and immunotoxins, are on the Commerce Control List. Only items meeting the definition of “medicine” and that are classified as EAR99 are eligible for export to Iran and Northern Sudan under the licensing procedures set forth in the appropriate regulations promulgated and administered OFAC.
Exporter guidance: The majority of medicines, including over the counter items, are considered EAR99 and OFAC does not require a CCAT. Vaccines, “immunotoxins” (antibody-toxin conjugates intended to destroy specific target cells (e.g., tumor cells) that bear antigens homologous to the antibody), certain toxin containing medical products, and diagnostic and food testing kits are controlled under ECCN 1C991, 1C395, or 1C995. It is the exporter’s responsibility to review these ECCNs, and if uncertain apply for a CCAT.
Agriculture Commodities: Agricultural commodities are defined in Section 772 of the EAR and reference is made to Section 102 of the Agricultural Trade Act of 1978 and listed at www.csrees.usda.gov.
Exporter guidance: OFAC does not require a CCAT for any agricultural items except for fertilizer, western red cedar, and live horses. (See 66 FR 36683).
On October 12, 2011, OFAC amended the Sudanese Sanctions Regulations, 31 CFR Part 538, and the Iranian Transactions Regulations, 31 CFR part 560, by issuing general licenses that authorize the exportation or reexportation of most food items to individuals and entities in an area of Sudan other than the Specified Areas of Sudan and in Iran. Certain specified food items, as well as exports to certain persons, requiring a greater level of scrutiny are excluded from the general licenses. These general licenses do not authorize the export of food items to military or law enforcement purchasers or importers. No other agricultural commodities are covered by these general licenses
The term “food” is broadly defined in OFAC's regulations as “items that are intended to be consumed by and provide nutrition to humans or animals, including vitamins and minerals, food additives and supplements, and bottled drinking water, and seeds that germinate into items that are intended to be consumed by and provide nutrition to humans or animals.” The term “food” does not include alcoholic beverages, cigarettes, gum, or fertilizer.
For complete details see: http://www.gpo.gov/fdsys/pkg/FR-2011-10-12/pdf/2011-26175.pdf.
(This page was last updated on March 20, 2012)