Diagnostic devices for use against coronavirus (COVID-19)
Only diagnostic tests authorized by Health Canada can be imported or sold in Canada. Unauthorized tests may not produce accurate results, leading to potential misdiagnosis. Health Canada has reviewed all authorized COVID-19 tests and confirmed that they will provide accurate and reliable results
COVID-19 is a new disease. A vaccine or therapy to treat or prevent this disease has not yet been developed. However, the COVID-19 pandemic has resulted in a global review of therapies that may be used to treat or prevent the disease.
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Canada is speeding up the importation and sale of medical devices used to diagnose, treat or prevent COVID-19. On March 18, 2020, the Minister of Health approved an interim order (IO) to expedite the review of these medical devices, including test kits. An interim order is one of the fastest mechanisms available to address large-scale public health emergencies.
Health Canada reviews all COVID-19-related submissions and applications as quickly as possible without compromising patient safety.
Nucleic acid amplification testing is the diagnostic technology used by public health laboratories across Canada and around the world for diagnosis of COVID-19 infection. As such, diagnostic tests using nucleic acid technology are being prioritized for review to increase the number of tests available in Canada to detect active infections of COVID-19.
Devices using serological technology are also being accepted for review, however the World Health Organization does not currently recommend serological assays for clinical diagnosis. Serological tests do not detect the virus itself. Instead, they detect the antibodies produced in response to an infection. It can take time (days to weeks) after an initial infection for antibodies to be produced. Further, the antibodies remain present for variable amounts of time after a viral infection is over. Research into serological testing is ongoing within Canada and worldwide and, along with expert advice, the results of this research will guide Health Canada’s regulation of serological tests.
How to get authorization
Under the IO, manufacturers are required to submit an abbreviated application to support the safety, effectiveness and quality of their medical device. The fees associated with an application through the IO pathway are waived. In addition, manufacturers applying through this pathway will not be required to hold a Medical Device Single Audit Programme (MDSAP) certification. This is the most effective pathway manufacturers should be following in order to apply for authorization.
A Guidance Document has been developed to help manufacturers and importers organize and submit an application for the sale or importation of medical devices that are manufactured, sold or represented for use in relation to COVID-19.
To submit an application for authorization under the interim order:
Please review the Guidance Document entitled Applications for Medical Devices under the Interim Order for Use in Relation to COVID-19 and submit the application to the Medical Devices Directorate at email@example.com.
Health care professionals can request access to COVID-19 medical devices not yet approved for sale in Canada through the Medical Devices Special Access Program.
For information about the licensing or authorization of medical devices in Canada, please contact the Medical Devices Directorate at firstname.lastname@example.org.
As with all drugs and medical devices, Health Canada will assess and monitor the safety and effectiveness of all products authorized under the IO, and will take immediate action if required to protect the health and safety of Canadians.
Manufacturers will still be required to follow strict post-market safety requirements such as mandatory problem reporting, recall procedures and complaint handling.
Special access programme
Healthcare professionals can request access to COVID-19 related medical devices not yet licensed in Canada, or authorized for sale under the IO pathway, through Health Canada’s Special Access Program (SAP). Applications are considered on a case-by-case basis.
For questions related to the SAP programme for medical devices, please contact the programme via email email@example.com or call 613- 946-8711. For urgent requests, please call 613-410-9186.
- Interim order respecting the importation and sale of medical devices for use in relation to COVID-19 guidance document
- Applications for Medical Devices under the Interim Order for Use in Relation to COVID-19 - Guidance Document
- Notice: Expedited Review of Health Product Submissions and Applications to address COVID-19
- Notice for Industry: Mandatory Reporting Requirement during the COVID-19 Pandemic
- Notice for Hospitals: Mandatory Reporting Requirement during the COVID-19 Pandemic
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