Canada Medical Device Compliance
Medical Devices are classified into one of four classes. Class 1 does not require a medical device license. Class 2 to 4 require a medical device license and differ based on the invasive nature of the device. All class of medical devices must be manufactured at a site that follows quality standards such as ISO 13485 or equivalent. If the medical device is manufactured outside Canada, the device must meet the quality standard and be brought into Canada by a licensed medical device importer who has a medical device establishment license (MDEL).
Health Canada charges a fee for each application of a Category 2 to 4 medical device. Quality Smart Solutions ensures a thorough due diligence is conducted to ensure your medical device meets the requirements of Health Canada in order for your medical device, it applicable, to be licensed.
Our Solutions for Canadian Medical Devices include:
- License Class Determination and Registration
- Medical Device Establishment License (MDEL) registration