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Are rapid COVID tests authorized in Canada?

When you’re caring for and diagnosing yourself at home, it’s important to know whether or not the things you are utilizing are authorized in Canada. Although the government giving the green light may not seem important at first, Health Canada’s seal of approval provides confidence in the devices you use for COVID testing. So, are rapid tests authorized in Canada? Here’s what you need to know.

Who provides approval in Canada?

stethoscope with canadian flag on the background

Health Canada is a government-appointed federal institution that helps Canadians maintain and improve their health. The main priority of Health Canada is to make sure that all Canadians have access to quality health services, and it also serves to decrease health risks for those in Canada. Of course, they serve all areas of health and not just approving tests or dealing with COVID-19 issues.

Are COVID tests authorized in Canada? 

Health Canada has authorized 107 COVID-19 testing devices so far. This number includes rapid antigen and PCR tests, which detect the virus. In addition, serological tests are also authorized, although they indicate antibodies due to infection and not the virus itself.

Has Health Canada authorized rapid antigen tests?

Yes, Health Canada currently endorses 27 rapid antigen COVID-19 tests. However, it’s important to note that although rapid tests are authorized in Canada, not all rapid tests are approved by Health Canada. MyZone Rapid Test Kits are authorized, so you can use our tests with confidence and know that they exceed the standards set forth by Health Canada.

What other COVID items has Health Canada authorized?

woman checking cellphone

Health Canada has four classes of devices that go through a process to be authorized.

  • Class I - respirators, face shields, masks, gowns
  • Class II - gloves, PPE, syringes, infrared thermometers, decontamination devices
  • Class III - ventilators
  • Class IV - COVID testing devices

Rapid antigen tests are categorized in Class IV. 

Why does it matter if a rapid test Is authorized? 

When your health is concerned, you should be using devices that have passed specific standards set forth by Health Canada. For a rapid test to be on the approval list, it must adhere to high standards while being accurate. Purchasing and using COVID-19 tests on Health Canada’s authorized list ensures that you use products that will give you the best results, such as our MyZone Rapid Antigen Tests.