Skip to contentSkip to navigation

Your Questions — 7 minutes

Why is it important to use a Health Canada-approved test for COVID-19?

Biron

Getting a false positive on a COVID-19 test or worse, a false negative, can have serious consequences. The first precaution to take is to ensure that the test being used has not only been authorized in Canada, but that it has not been recalled.

If the test is authorized in another country, why not in Canada?

To obtain approval of their product from Health Canada, all manufacturers and importers must go through a rigorous process that can take several months. In Canada, Health Canada is responsible for approving diagnostic tests. In the United States, the Food and Drug Administration (FDA) fulfills this obligation, while in Europe, the European Commission (EC) is responsible for approval in member states.

As with drugs and vaccines, approval of a product by a government agency is not transferable from one country to another. Philosophy, rules of approval, effects lobbying and political pressure vary from one jurisdiction to another. Also, it is not uncommon for a product authorized in the United States to not be authorized in Canada or Europe, and vice versa.

The approval process involves multiple steps that add up to a minimum of 60 days. The list of important information to submit to Health Canada is long, focussing not only on the product’s reliability compared to proven methods, but also the manufacturer’s reputation, safety, labelling and other criteria. [1]

Fast-tracking an application

Since March 18, 2020, Health Canada has had emergency authority to fast-track the approval of new COVID-19 screening devices. This authority was granted by order of the federal Minister of Health, Patty Hajdu, to avoid jeopardizing the health and safety of Canadians. [2]

While Health Canada does not specify the timeframes for approving each product, there is no doubt that these delays have been shortened since the beginning of the pandemic. Indeed, the first screening test for COVID-19 (Roche SARS-CoV-2) was authorized by Health Canada on March 17, 2020, barely two months after the publication of information required to develop this type of test. [3] Obviously, this delay must be added to the time it takes manufacturers to develop and test new devices.

Read more: Multiple ways to screen for COVID-19 (infographic)

Why are certain tests recalled after they have been authorized?

In addition to authorizing their use, Health Canada monitors the tests after approving them. Manufacturers and importers are required to provide Health Canada with all incident reports regarding their products. This may explain why some products already approved under emergency rules have later needed to be withdrawn from the market. This was the case with the rapid test developed in Ottawa by Spartan Bioscience, which was withdrawn from the market less than a month after being launched. The quality of the results obtained in the field did not match the quality alleged in the application. Quebec itself had ordered 200,000 of these devices. [4]

As a result, Health Canada recalls are a critical part of the process for approving a diagnostic test.

How do we ensure a screening test is authorized in Canada?

To make the right choice, check to see if the product appears on the list of products approved by Health Canada. [5]

Also, be aware that all Canadian medical laboratories, both public and private, are required to use tests authorized by Health Canada. Failure to do so can result in severe penalties, including loss of accreditation. Although it would be prudent to ensure that these stringent standards are also applied to tests sold online, this is not the case. When in doubt, use a laboratory that you trust.

For professional support, we’re here.

We offer services that can assist your doctor in diagnosing COVID-19 and other winter ailments and determining the appropriate treatment.

If you have any questions or need more information, please don’t hesitate to call our customer service number at 1 833 590-2713.

  1. Health Canada, “Applications for medical devices under the Interim Order for use in relation to COVID-19: Guidance document,” March 27, 2020 (August 28, 2020 update), https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/interim-order-importation-sale-medical-devices-covid-19/guidance-medical-device-applications.html (accessed on February 9, 2021).
  2. Health Canada, “Interim order respecting the importation and sale of medical devices for use in relation to COVID-19,” March 18, 2020, https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/announcements/interim-order-importation-sale-medical-devices-covid-19.html (accessed on February 9, 2021).
  3. Holmes E., “Initial genome release of novel coronavirus 2020,” January 14, 2020, http://virological.org/t/initial-genome-release-of-novel-coronavirus/319 (accessed on February 9, 2021).
  4. Stéphanie Marin, “Un test rapide et portatif de dépistage approuvé par Santé Canada,” La Presse [Montreal], April 13, 2020, https://www.lapresse.ca/covid-19/2020-04-13/un-test-rapide-et-portatif-de-depistage-approuve-par-sante-canada (accessed on February 9, 2021).
  5. Health Canada, “Authorized medical devices for uses related to COVID-19: List of authorized testing devices,” https://www.canada.ca/en/health-canada/services/drugs-health-products/covid19-industry/medical-devices/authorized/list.html (accessed on February 9, 2021).