Authorized medical devices for uses related to COVID-19: List of authorized testing devices
COVID-19 variants and testing devicesThere is no evidence at this time that variants affect the ability of Health Canada-authorized diagnostic tests to confirm COVID-19 cases. Health Canada is working with other regulators and manufacturers of COVID-19 test devices to determine what, if any, impact variants may have on the effectiveness of diagnostic tests. If an issue is identified, we will work quickly with the manufacturers and public health laboratories to respond and keep Canadians informed.
Health Canada is receiving a very high volume of requests for authorization. We are unable to prioritize requests for status updates at this time. If you learned recently that a device was authorized, please allow at least 48 hours for this list to be updated.
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 other types of COVID-19 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. Only the most conservative values pertaining to SARS-CoV-2 are presented where either:
- multiple clinical datasets have been provided to Health Canada for evaluation or
- the test is designed to identify more than just SARS-CoV-2
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 that intramuscular COVID-19 vaccinations will 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 testing devices 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 Interim Order No. 2 for importing and selling medical devices (enacted March 1, 2021). Some devices were first authorized under Interim Order No. 1 for importing and selling medical devices (March 18, 2020, to March 1, 2021). Any testing device that was first authorized under Interim Order No. 1 is deemed as authorized under Interim Order No. 2.
The entries in this list represent each individual device identifier included on each interim order (IO) authorization. In other words, a single IO authorization may contain multiple devices, such as a testing device and control kits, that are meant to be used together to conduct the test. Within the IO authorization, each device is listed separately. The "IO Authorization Date" column indicates the first date that the testing device was authorized for sale. Manufacturers may amend their IO authorizations to add additional devices over time. The date that new devices are added is reflected in the "Device first issued" column.
The entries also indicate what type of application the testing devices are authorized for lab-based, point-of-care or self-testing applications:
- Lab-based tests are conducted in a lab environment by a trained laboratory technician.
- Point-of-care testing devices are used by an approved operator (often a health care professional) in a near-patient environment like a medical office or at the bedside. The patient waits for the results.
- Self-testing devices are those that can be purchased and used by the general public.
This list is updated every day by 5:00 am EST.
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