Change in classification of COVID-19 testing devices: Notice to industry
This notice is to inform manufacturers, importers and distributors of the change in classification of COVID-19 testing devices.
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Background
During the COVID-19 pandemic, SARS-CoV-2 was considered a life-threatening disease with high transmission risk. An accurate diagnosis was critical to reducing public health impacts.
In response, Health Canada:
- classified all COVID-19 testing devices as Class IV medical devices and
- authorized a range of COVID-19 testing devices for sale under the Medical Devices Regulations
Since the pandemic, the scientific evidence, risk profile of the disease and public health context have evolved. We have thus re-evaluated the classification of these devices in line with the classification rules in Schedule 1 of the regulations. We have updated the classification to help keep regulatory oversight in proportion to the medical device's risk.
About the classification change
As of March 18, 2026, COVID-19 testing devices are classified as follows:
- Laboratory-based testing devices: Class II under Schedule 1, Part 2, Rule 2
- Point-of-care and self-testing devices: Class III under Schedule 1, Part 2, Rule 6
The classification of multiplex testing devices and analyzers that can detect other diseases may also be impacted. The classification of these devices will follow the highest-risk component detected (Schedule 1, Part 2, Rule 7).
The new classification applies to all COVID-19 testing devices currently authorized or licensed for sale under the regulations. This includes multiplex tests and analyzers where applicable.
Implementing the classification change
The new classification does not impact a manufacturer's ability to import and sell their authorized or licensed device.
No action is required from applicants, authorization or licence holders at this time.
We will contact:
- applicants about their medical device licence application and
- authorization and licence holders to issue updated authorizations or licences with the new classification
All new applications for medical device licences should reflect the updated classification.
For information on submitting an application, consult:
Contact us
If you have questions about this notice, contact the Medical Devices Directorate at meddevices-instrumentsmed@hc-sc.gc.ca.