Develop and validate your medical device compliantly
As all medical devices sold in Canada and US must meet all 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.
These medical devices include a wide range of products including, but not limited to:
- Artificial heart valves
- Hip implants
- Medical laboratory diagnostic instruments
- Contraceptive devices
Depending upon the product classification and the targeted 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 Licence 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 further to that, all licenses are met and it enters the Canadian and the US market in a quick and stress-free manner.