The U.S. is known as one of the world’s leading countries in terms of medical innovation. Medical advances in the last 30 years have increased life expectancy by five years and decreased heart attack fatalities by more than half. There are currently over 1.9 million jobs in the U.S medical industry, of which small businesses are the leading creator. Due to the industry’s size, countries worldwide rely on the U.S. for their exported medical devices. Global reliance on medical equipment is also perfect for small companies planning to grow their business (some of the most widely exported medical devices are X-ray equipment and MRI systems). This article will explain what you will expect and how to prepare for exporting to other countries from the U.S.

Before shipping, it is essential to understand the regulations for transporting medical equipment outside the U.S. For example, any medical device a company wants to export must have prior Food and Drug Administration FDA approval. The FDA regulates the sale and safety of any medical device sold in the U.S. If the FDA has cleared a device, it can be sold and exported anywhere in the world. In the scenario of non-clearance in the U.S, devices must follow export provisions of the FD&C Act.

It is also crucial to know the policies that the country of destination follows. Contact a customs broker for information on the guidelines and required documents. Once meeting the policies, the shipper must find carriers to take the shipment to a port and export it internationally. The means of conveyance that the devices are transported can include planes, vessels, and trucks for countries connected by land. Different countries may also have specific tariffs that shippers must pay for imported medical devices.

The Documents Needed

When exporting, the shipper must have the correct paperwork available to prevent issues in the shipping process. This list is a summary; however, the documents may depend on the type of medical device. For more information, contact a freight forwarder. The documents can include the following:

• Certificate of Exportability 801(e)(1)
• Certificate of Exportability 801
• Non-Clinical Research Use Only Certificate
• Certificate to Foreign Government
• Simple Notifications
• Export Permit Letters

The Center for Devices and Radiological Health (CDRH) issues export certificates at the shipper’s request. The cost to issue a certificate is $175 for the first one and $85 for each successive certificate in the same request. A certificate is limited to 25 pages, and requesting a copy of the same certificate is $175 per 25-page increment. For a detailed explanation, visit the FDA Website. Permit letters and simple notifications do not require a fee to acquire.

The global medical device market is currently an estimated $536 billion industry. Over $159 billion is projected to come from the U.S. by the end of 2022. The exporting of medical equipment is in high demand and can help a business expand in many ways. Due to the requirements and logistics involved in the exportation process, it is ideal to find a customs broker to assist. If you plan on exporting medical devices to any country internationally, contact A1 Worldwide Logistics at 305-821-8995. Our experienced freight forwarders will guide you through the exportation process and provide open communication every step of the way.