We Can Help Develop and Validate your Medical Device
All medical devices sold in Canada and the US must meet the requirements of the Medical Device Regulations and Code of Federal Regulation (CFR), respectively.
The medical device classification system is risk based, with four groups of medical devices in Canada and three in the US.
Medical devices include a wide range of products including, but not limited to:
- Pacemakers
- Artificial heart valves
- Hip implants
- Syringes
- Medical laboratory diagnostic instruments
- Contraceptive devices
- Light therapies
- Contact lenses
- Insulin pumps
Depending upon the product classification and the target market, manufacturers may be required to:
- Obtain a Medical Device License prior to selling their product in Canada. Even if a device license is not required, all importers, distributors, and manufacturers of devices require an Establishment License in order to operate in Canada.
- Obtain a Medical Device Establishment, Premarket Notification “510(k)” FDA clearance, or Premarket Approval (PMA), in the US. These requirements are subject to the medical device classification.
Our in-house regulatory experts will ensure that your product receives the right classification and all licenses are acquired before entering the Canadian or US market.
