Medical Device Registration in the America Region

US FDA medical device registration involves determining medical device classification, selecting the correct FDA regulatory pathway (such as 510(k) premarket notification, De Novo, or PMA), preparing technical documentation, and ensuring compliance with FDA Quality System Regulation (QSR/QMSR). Manufacturers must also complete FDA medical device Establishment Registration and Listing before marketing their devices in the United States.

In Canada, medical devices are regulated by Health Canada using a four-class risk framework (Class I–IV). Most Class II–IV devices require a Medical Device License (MDL), while manufacturers, importers and distributors often need a Medical Device Establishment License (MDEL). Unlike the US 510(k) process, Canada focuses on safety, effectiveness and QMS evidence aligned with ISO 13485 and MDSAP.

An MDL (Medical Device License) authorizes a specific device to be sold in Canada, based on its safety, effectiveness and intended use. An MDEL (Medical Device Establishment License) applies to companies conducting regulated activities such as manufacturing, importing or distributing devices. Many organizations require both an MDL and MDEL to operate compliantly under Health Canada medical device regulations.

Your FDA pathway depends on your device’s risk, novelty and availability of predicate devices.

• 510(k) is for devices demonstrating substantial equivalence to an existing device.
• De Novo is for novel, low- to moderate-risk devices with no predicate.
• PMA is required for Class III medical devices needing substantial clinical evidence.
  A correct pathway decision is a key part of your US FDA medical device registration strategy.

Yes. Foreign manufacturers selling medical devices in the US must appoint a US agent to support FDA communications, inspections and compliance activities. In Canada, manufacturers outside the country often rely on a licensed Canadian importer or distributor to meet MDEL obligations and coordinate with Health Canada.

In the US, devices must comply with FDA QSR/QMSR, including design controls, CAPA and production controls. In Canada, manufacturers typically need ISO 13485 certification, and participation in MDSAP is often required for Class II–IV MDL submissions. Both countries expect robust QMS documentation to support medical device registration and post-market compliance.

FDA review timelines vary. Some 510(k) submissions may be cleared within a few months, while PMA approvals can take significantly longer. For Canada, MDL review timelines depend on device class, Class II medical devices may move faster, while Class III and IV require more extensive evidence and review. Strong documentation and a clear regulatory strategy help minimize delays in both markets.

Freyr provides end-to-end support for US & Canada medical device registration, including device classification, FDA pathway selection, 510(k)/De Novo/PMA preparation, MDL/MDEL applications, QMS alignment (ISO 13485 & MDSAP), US FDA agent services, and post-market compliance. We help manufacturers build a unified North America regulatory strategy that accelerates approvals and reduces regulatory risk.