Search
U.S. & Canada are the most lucrative markets for medical devices in terms of market acceptance as well as in terms of existent regulations required for necessary licenses and approvals. With a strong demand for high-quality medical device technologies, the U.S. and Canada markets continue to attract manufacturers worldwide. But tracking, decoding, and aligning with region-specific medical device Regulatory requirements, at times, poses a challenge for manufacturers, if not implemented intelligently. For example, U.S. requires all importing companies to appoint a registered U.S. agent to act as a connection between the company and the USFDA.
Head quartered in Princeton, NJ, U.S., Freyr has strong capabilities in the region and provides end-to-end Regulatory support to varied classes of Medical Devices ranging from software based to In-Vitro Diagnostic (IVD) Devices.
The Unites States of America is a highly regulated and competitive market with scores of medical devices and IVDs receiving approvals each year. Medical devices in USA are regulated by the Center for Devices and Radiological Health (CDRH) under the Food and Drug Administration (FDA).
Medical Device Registration USA
CDRH Medical Device approvals in the US are achieved through any of the registration pathways. The appropriate pathway is determined by a risk-based medical device classification system.
USFDA Medical Device Classification
Device Class |
Risk |
Registration Pathway for approval |
I |
Low Risk |
510(k) exempt |
II |
Moderate Risk (With predicate device) |
|
Moderate Risk (Without Predicate Device) |
||
III |
High Risk |
Companies lacking a local presence in the U.S. are required to appoint a U.S. Agent.
Canada has one of most stringent regulatory systems for medical devices. All the medical devices in Canada are regulated by Health Canada
Medical Device Registration Canada
Regulatory pathway is determined upon risk-based classification of the device.
Device Class |
Risk |
Regulatory Pathway |
I |
Low |
|
II |
Low-Moderate |
Medical Device License (MDL) |
III |
High-Moderate |
Medical Device License (MDL) |
IV |
High |
Medical Device License (MDL) |
There is no requirement for the manufacturer to appoint an Authorized Representative in Canada.
Successful submissions for varied class of devices ranging from software to sutures
Local affiliate access to meet the challenges of authority and language-specific requirements
Dedicated and expert personnel to provide Medical Device and IVD Regulatory support
Cost-effective model for In-country or Legal representation support
Have successfully delivered various projects across U.S. and Canada
Headquartered in the U.S.
Our Newsletter