Contact OFAC First The most important piece of advice we can give to anyone who is interested in sending their device to a sanctioned country is to schedule a call with Office of Foreign Assets Control (OFAC). We urge clients to take advantage of the list of phone numbers on their site (link below). Getting someone on the phone at OFAC may seem like an arduous process, however, the OFAC team is the best source to help you understand the process and guidelines you will need to adhere by when exporting in sanctioned countries. https://www.treasury.gov/about/organizational-structure/offices/Pages/Office-of-Foreign-Assets-Control.aspx
Make sure you know who you are working with. When doing business in a sanctioned country, the number one most crucial rule is to absolutely know everyone who will contribute in any way to your project. Remember per OFAC guidelines, if you are working with a lab/facility/or hospital, please be aware that if even one employee is on the “blocked designated person” list, you and your company will be held liable. You can find the list of designated or blocked entities below. www.treasury.gov/resource-center/sanctions/SDN-List/Pages/default.aspx.
File for an OFAC License before you process any monetary transactions. Whether you are paying your shipping company for shipping company materials to Iran, paying an in-country representative for submitting your product registration, or simply being payed by a client for your goods, you must file for an OFAC license. You MUST apply for a license BEFORE any transaction occurs, no matter how small. You can find access to the license application below. https://www.treasury.gov/resource-center/sanctions/Pages/licensing.aspx
Have a product that has already obtained FDA or CE approval. Most of the sanctioned countries mainly follow European Union (EU) Medical Device Directives, but also accept FDA or any other GHTF country approvals. Medical devices with CE Mark and or GHTF country clearance can obtain market clearance in sanctioned countries fairly easily.
Find an In-Country Regulatory Representative. In our experience, we’ve often found that business in smaller nations is often bureaucratic. Therefore, the most effective method to get work done is by influencing others to help. For this reason, finding an experienced in-country representative to assist you with registration and importation in a sanctioned country will be necessary for you to obtain the approval in a timely and cost-effective manner.