Testing devices for COVID-19: Overview
There are new lists of authorized COVID-19-related medical devices. These lists are a result of new regulatory tools in place to expedite access to COVID-19 medical devices.
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Types of testing
Health Canada regulates the sale and import of commercial testing devices relating to COVID-19. The majority of submissions received by Health Canada are for 2 types of commercial testing devices:
- nucleic acid-based testing
- serology-based testing
Public health laboratories across Canada and around the world use nucleic acid-based testing to diagnose COVID-19 infection. We have authorized several diagnostic tests using this technology to increase the number of devices in Canada to detect active infections of COVID-19.
We have also authorized devices using serological technology. However, these are not intended for use in clinical diagnosis. For more information, please consult serological testing devices for COVID-19. This page also includes links to specific guidance for serological testing device applications.
Consult the testing devices that Health Canada has authorized to date for use related to COVID-19.
Only testing devices authorized by Health Canada can be imported or sold in Canada. Unauthorized tests may not produce accurate results, leading to potential misdiagnosis. Health Canada confirms that authorized COVID-19 tests are well supported by evidence indicating they will provide accurate and reliable results.
Health Canada does not regulate lab-developed tests. Laboratories may develop methods for diagnosing COVID-19 or detecting antibodies to COVID-19 for use in those laboratories. This is how all initial diagnostic testing for COVID-19 in Canada was accomplished.
Canada's National Microbiology Laboratory (NML) developed a nucleic acid-based testing method and then validated that the test would produce reliable and accurate results. The NML shared this method with other public health laboratories across Canada so that they too could use it.
Lab-developed nucleic-acid tests make use of machines (called thermocyclers) that are commercially available. Health Canada does not regulate the use of those machines in lab-developed tests. Laboratories that use these machines for diagnosis are responsible for validating their results in accordance with the requirements of their jurisdiction.
List of applications under evaluation
Health Canada publishes a list of applications for testing devices that are currently under evaluation. This list provides information on those products that have been submitted to Health Canada for authorization. These applications for testing devices are complete and ready for scientific review. The applicant has agreed they can be made public.
Health Canada has not authorized the testing devices on this list. The Food and Drugs Act prohibits the sale or importation of these devices until an authorization or licence has been issued.
Being on the list of applications does not guarantee that Health Canada will authorize a product.
We will only discuss details of an application with an authorized representative of the applicant.
How to get authorization
Under the interim order for importing and selling medical devices related to COVID-19, manufacturers submit an application that explains the safety, effectiveness and quality of their medical device. We are waiving the fees for these applications.
To submit an application for authorization, follow these steps:
- Review the guidance document on how to apply for medical devices for use in relation to COVID-19, under the interim order.
- If you are submitting an application for a serological test, also review the
- Prepare your submission package. Each submission must include enough information, including device labelling, so that Health Canada can authorize the device.
- Submit your application to the Medical Devices Directorate at email@example.com.
For information about the licensing or authorization of medical devices in Canada, please contact the Medical Devices Directorate at firstname.lastname@example.org.
- Interim order respecting the importation and sale of medical devices for use in relation to COVID-19
- Applications for medical devices under the interim order for use in relation to COVID-19 - guidance document
- Requirements for serological antibody tests submitted under the COVID-19 interim order - guidance document
- COVID-19 medical devices
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