For medical device companies looking to make it in the US, there’s one huge hurdle standing in the way — importation. That’s because all medical devices need to be approved by the US Food and Drug Administration (FDA) and then cleared by the U.S. Customs and Border Protection (CBP). And this process can be long, challenging, confusing, risky, and expensive if not done correctly — and with the right help. 

As Founder and CEO of Preferred Depot, the premier white label operations management and consulting company in the US, I have partnered with some of the largest medical and health technology companies to help them ensure a smooth medical device importation process as they enter or grow in the US market. 

So, to help you get this seamless experience for your company, I’m detailing the must-know info for importing medical devices into the US in this two part series. First, let’s discuss how to navigate FDA compliance. 

US Agent

A key step in importation is designating a US agent – a requirement for foreign manufacturers. These are specialists who work with you to understand and navigate communication with the FDA.

Medical Device Classification 

You’ll then need to determine device classification. Medical devices are designated one of three classifications by the FDA with Class I being the lowest risk and Class III the highest risk. Class I items, such as bandages, are subject to general controls, Class II items are subject to general and potentially special controls, and Class III items such as pacemakers are subject to rigorous controls.   

The Premarket Process

Medical devices in lower classifications will need Premarket Notification 510(k): premarket submissions demonstrating safety and effectiveness while Class III devices will require Premarket Approval (PMA): approval by the FDA – including a scientific and regulatory review evaluating a medical device’s safety and effectiveness. However, some Class I devices are exempt from these processes.

Establishment Registration and Device Listing

Both foreign importers and foreign manufacturers must register with the FDA annually, list their device, and provide detailed and comprehensive information about their instruments and the activities of their establishments. 

Quality Systems Regulation Compliance

Medical device companies must ensure compliance with the FDA’s Quality Management System Regulation (QMSR) and the current good manufacturing practices (CGMPs). This is a flexible set of guidelines that manufacturers must define to prove their methods and procedures are consistent with creating safe and effective products — from design through post-distribution. 

To maintain compliance, it is best to work with an operations consulting company that is the International Organization for Standardization (ISO) certified, such as Preferred Depot.

Labeling Requirements

The FDA also has specific labeling standards that all medical devices imported into the US must follow — including the necessary information required to be safely and effectively used. This includes intended use, language requirements, disposal directions, warning statements, and more. 

Medical Device Reporting

The FDA has strict Medical Device Reporting (MDR) regulations for medical devices — including reporting past complaints about their devices, malfunctions that could cause harm, and knowledge of a device that contributed to serious injury or death. Certain Class II and Class III devices might also be required to be tracked from manufacture to post-market surveillance.

Seamless Entry

While these are the essentials to navigating FDA compliance, this is only one hurdle when it comes to importation. The next step is preparing for entry and inspection at the US border. To learn about how to achieve a seamless customs experience, read all about it in part two of our Medical Device Importation series!

 

At Preferred Depot, we have helped countless medical device companies manage their operations and logistics in a safer, smarter, and more cost-effective way. Plus, we make navigating the tricky importation landscape easy and stress free. But that’s not all — we’re your partner from before your product arrives until long after it achieves success in the US market. To learn more about Preferred Depot’s white label medical device operations management and consulting services, visit us at preferreddepot.com.