Covid-19 test kits, either antigen or molecular (PCR) based, are In-Vitro Diagnostics Tests (class IV) devices. These test kits can be registered faster under the Interim Order Authorization pathway (IO). Health Canada has published a list of medical devices that have received interim order Authorization.
To bring Covid test kits into Canada, you will need the following:
• The testing device is registered with Health Canada under interim order or permanent medical device license. If the device is not registered, then this process must happen first before importation and/or distribution is permitted.
• If you intend to import and sell directly to consumers, you will need a medical device establishment license (MDEL)
• If you intend to resell these devices to a retailer or reseller, you must obtain an MDEL with the distributor activity (note that one MDEL can cover one or more activities i.e. importing and/or distributing)
• As an MDEL holder you must follow the practices and procedures based on the respective activities you plan to conduct. Standard Operating Procedures are required for your business.
• If your business generates revenue under $5 million you may qualify as a small business and your Health Canada application fees will be reduced by approximately 25%
• Health Canada fees for an MDEL are due before license issuance (Health Canada will notify you via email) and an annual renewal fee is due when you submit your license renewal each year by April 1. Please note that MDEL fees are not prorated.