All Medical Devices and healthcare products sold in Canada must meet all the requirements of the Medical Device Regulations even if they are currently FDA approved.
These medical devices include a wide range of products including, but not limited to, pacemakers, artificial heart valves, hip implants, syringes, medical laboratory diagnostic instruments and contraceptive devices.
Depending upon the product classification, 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.
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 market in a quick and stress-free manner.