MAE Group

Marketing Your Medical Device Globally and Export Compliance

Congratulations – you just received your Clearance Letter from the FDA after months of hard work by a team of dedicated professionals. That Clearance Letter, the CE Marking, and ISO 13485 Certification are the gateway to international markets. You can now move forward to submit dossiers and market your product globally.

As you look to ship your product to the four corners of the world, you have just entered the realm of export compliance. However, prior to making the first shipment outside of the United States, you must classify your product including components and subassemblies to determine if you need an export license. Factors that are included in this determination are the product’s technical characteristics, destination, end-user and end use.

The Department of Commerce’s Bureau of Industry and Security (BIS) is responsible for implementing and enforcing the Export Administration Regulations (EAR) that regulate the export and re-export of most commercial items. BIS regulates items known as “dual-use” which means items that have both commercial and military or proliferation applications.

Just in case you’re wondering – any item that is sent from the United States to a foreign destination is an export. Items include commodities, software or technology, materials, product, blue prints, design plans, packages and technical information, etc.

How do you determine if your product requires an export license? Start by making certain your product falls under the Department of Commerce jurisdiction. If it does, then classify the product using the Commerce Control List (CCL) and determine the Export Control Classification Number (ECCN). Then cross-reference the ECCN Controls against the Commerce Country Chart (CCC) to see if a license is required. If a license is required you should work with BIS to determine if your export qualifies for an exception or if not, you must apply and secure the license prior to the product leaving the United States.

The world of import and export compliance is complex. Whether you are just starting to ship products internationally or have been marketing your products globally for years, you must take into consideration trade compliance regulations in addition to the familiar medical regulations promulgated by the US, EU and other government agencies. Shipping a product to a country such as China or India may be very beneficial to your company but product registrations are only half of the equation, you must know and understand the trade side of the equation if your company is to maintain a good standing with all customers, including the US government.