Shipping Regulations for Medical Devices

Navigating the Complexities: Understanding Shipping Regulations for Medical Devices in the United States

From FDA regulations and partnering with a Customs Broker to accurate, specific documentation, we will explore the regulations that must be considered when shipping medical devices.

Written By: Debbie Jung 

Shipping medical devices is a complicated, multi-layered task due to the device's fragility, size, and sometimes time and temperature sensitivity. Regulations must be followed when importing or exporting these goods to and from the United States. 

"All medical devices imported into the United States (U.S.) must meet the regulatory requirements of both the U.S. Bureau of Customs and Border Protection (CBP) and FDA. Products that do not meet FDA regulatory requirements may be detained upon entry."  * 

Food and Drugs Administration (FDA) and Customs Border Protection (CBP) Regulations

The Food and Drugs Administration (FDA), since approved in 1906, has been protecting and promoting the development of many consumer products, including medical devices. There are specific FDA shipping regulations for medical device companies, and it intends to provide safety and effectiveness for all medical devices. Navigating these import and export regulations is crucial for successful international medical device shipping.   

Medical Device companies must also navigate Customs Border Protection (CBP) regulations on top of the FDA regulations. The CBP plays a crucial role when clearing the devices into the United States.  

An importer or a Customs Broker must file the required information to the CBP and the FDA for proper entry. The required information includes the country of origin, importation product code, importer product description, manufacturer, shipper, and a Harmonized Tariff Schedule (HTS) Code. 

The HTS Code is an identification code of the medical device in the importing documents. These HTS Codes can generally be found on official government websites or a Tariff Classification Database such as World Customs Organization’s page with different Harmonized System Codes. 

Partnering with a Custom Broker

By partnering with a trusted customs broker, you can expedite the process with the FDA and the CBP because the information will be completed accurately and on time. Time is a crucial factor here, as you must be able to respond to any requests for additional documentation for shipments. If you commonly ship medical devices, partnering with a reliable customs broker that communicates effectively will help ease this process.  

Some countries have restricted regulations regarding medical devices, and to avoid any penalties, delays and fees, it's recommended to work with an expert in logistics that can guide you through the export process. 

Classify Your Medical Device for Proper Labelling

Another consideration is classifying your medical device for proper labeling that will ensure customs clearance, risk management, and safe handling with transportation. The FDA has classified all medical devices into three regulatory classifications: Class I, II, and III. The FDA regulates each medical device depending on its risk to the user or patient. The higher the risk, the higher the classification.  

Device classifications depend on the intent behind the medical device. You can determine your classification by going directly to the classification database run under the FDA. 

3 Tips for Safely Shipping Your Medical Device 

1. Packaging and Labeling: To avoid damaging the device, consider packaging that has enough cushioning, labels that clearly provide instructions on how to handle the package, and include any required warning label. 
2. Device with lithium batteries: for medical devices that contain lithium batteries, specific criteria for packaging and documentation must be met. If you want to learn more about shipping with batteries, click here.  
3. Cold Chain: for products requiring temperature-controlled shipping, use validated packaging and methods to maintain the temperature until the package arrives at the destination. 

Need help understanding shipping regulations for medical devices?  

Mercury specializes in importing and exporting medical devices that meet all shipping requirements with the FDA and CBP. As specific documentation, packaging, and shipment labeling can be tricky, partnering with a trusted logistics partner that can handle this process will save you immense time. At Mercury, we deal with shipping, manage all the paperwork, and ensure to comply with all the requirements. We act as a customs broker for your company and control all communications with the FDA and CBP, all while coordinating shipping and sometimes even storing your medical device to ensure success.  

*References: https://www.fda.gov/medical-devices/importing-and-exporting-medical-devices/importing-medical-devices-and-radiation-emitting-electronic-products-us