Key takeaways
Medical device shipping in and out of the United States must meet both FDA and CBP requirements at the same time, not one or the other.
Required documentation includes country of origin, product code, manufacturer and shipper details, and a Harmonized Tariff Schedule (HTS) code.
The FDA classifies medical devices into Class I, II, or III based on patient risk, and classification affects labeling and clearance requirements.
A customs broker who specializes in medical devices reduces delay risk by filing accurate, complete documentation the first time.
FDA and CBP Regulations for Medical Device Shipping
Shipping medical devices is a complicated, multi-layered task due to a device's fragility, size, and sometimes temperature sensitivity. All medical devices imported into the United States must meet the regulatory requirements of both the FDA and U.S. Customs and Border Protection (CBP). Products that do not meet FDA requirements may be detained upon entry.
The FDA regulates medical devices for safety and effectiveness, while CBP clears devices into the United States at the border. An importer or customs broker must file the required information to both agencies for proper entry: country of origin, importation product code, product description, manufacturer, shipper, and a Harmonized Tariff Schedule (HTS) code.
The HTS code identifies the medical device on import documents. HTS codes can be found on official government sites or a tariff classification database such as the World Customs Organization's page.
Partnering with a Customs Broker
Partnering with a trusted customs broker helps the FDA and CBP filing get completed accurately and on time. Timing matters, since you must be able to respond quickly to any request for additional documentation on a shipment. If you ship medical devices regularly, a broker who communicates proactively will ease this process considerably.
Some countries maintain restricted regulations for medical devices. Working with a logistics partner who understands the export process for your destination markets helps avoid penalties, delays, and unexpected fees.
Classify Your Medical Device for Proper Labeling
Correct classification drives correct labeling, and correct labeling drives customs clearance. The FDA classifies all medical devices into three regulatory classes: Class I, II, and III, based on the device's risk to the user or patient. The higher the risk, the higher the classification.
Classification depends on the device's intended use. You can confirm your device's classification directly through the FDA's classification database.
If your device is later recalled, classification also determines the FDA response timeline your company must follow.
Compliance Documentation for Packaging and Batteries
Two documentation points come up often. First, devices containing lithium batteries have specific packaging and documentation requirements before they can ship; see Mercury's guide to shipping protocols for lithium-ion batteries for the details.
Second, products requiring temperature-controlled shipping need validated packaging and a documented method for maintaining temperature until arrival, which should be referenced in your shipment's compliance file alongside the HTS and classification data.
For hands-on packaging and handling guidance beyond compliance documentation, see Mercury's best practices for shipping high-value medical devices.
How Mercury Supports Medical Device Shipping
Mercury specializes in importing and exporting medical devices that meet FDA and CBP requirements. Specific documentation, packaging, and shipment labeling can be tricky to get right consistently, and getting it wrong is what causes a detention at the border.
Mercury handles the shipping, manages the paperwork, and acts as your customs broker for all communication with the FDA and CBP, while coordinating shipping and storage as needed.
Contact Mercury to talk through your medical device shipping requirements.
Sources
Start shipping today!
Start your shipment now — no login required. Fast, secure, and guided by experts.
