Authorized medical devices for uses related to COVID-19: List of authorized testing devices
This page is updated daily by 5:00 am EST.
If you recently learned that a device was authorized, please allow at least 48 hours for this list to be updated. Health Canada is receiving an extremely high volume of requests for authorization. We are unable to prioritize requests for status updates at this time.
In Canada, medical devices are classified into one of 4 classes. Class I represents the lowest risk and Class IV the highest. To determine the appropriate classification for their device, manufacturers are encouraged to refer to the classification rules for medical devices in the Medical Devices Regulations.
The following are examples of COVID-19 medical devices that fit within each class:
- Class I: masks, respirators, gowns, face shields
- Class II: infrared thermometers, gloves, personal protective equipment (PPE) decontamination devices, syringes
- Class III: ventilators
- Class IV: SARS-CoV-2 testing devices
For COVID-19 devices other than testing devices, see the list of authorized medical devices other than testing devices.
Sensitivity values are presented here to provide transparency around clinical performance data that were filed with Health Canada at the time of submission. The sensitivityFootnote * value indicates the proportion of patients who show as positive using the subject test. The reverse transcription polymerase chain reaction (RT-PCR) test, which is the gold standard testing method, is used for comparison. Where multiple clinical datasets have been provided to Health Canada for evaluation or where the test is designed to identify more than just SARS-CoV-2, only the most conservative values pertaining to SARS-CoV-2 are presented.
The performance of authorized COVID-19 testing devices has not been assessed in people who are vaccinated against COVID-19. However, Health Canada does not expect intramuscular COVID-19 vaccinations to interfere with the performance of authorized nucleic-acid or antigen-based testing devices.
Tests that identify antibodies to the spike protein of the SARS-CoV-2 virus, however, will be unable to distinguish between people who have been infected and those who are vaccinated. Manufacturers of authorized tests will be asked to change their product labelling to reflect the impacts of vaccination on the performance of COVID-19 testing devices.
We have authorized the following testing devices for sale or import in Canada through the interim order for importing and selling medical devices.
Note that number of entries appearing on this list represents the number of individual device identifiers included on each Interim Order authorization. For example testing devices, and control kits are listed separately.
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