In Vitro Diagnostic Devices and Registration in Canada
An ‘In Vitro Diagnostic’ device is a medical device or product subject to section 3 of the Medical Device Regulations. These devices are used in vitro for the analysis of specimens derived from the human body.
If you would like to sell in vitro diagnostic (IVD) devices in Canada, you must first register and obtain a license from Health Canada. Health Canada has a four-tier, risk-based classification system (Class I, Class II, Class III, and Class IV) for IVD products under its jurisdiction.