Medical devices for COVID-19: Conducting a clinical trial

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Clinical trial regulations

Clinical trials, or investigational testing, are tests done to look at the safety and effectiveness of a medical device. These trials are authorized by Health Canada and are conducted on a device that:

A trial provides information about the risks and benefits of a medical device. Clinical trials also require informed consent from patients who wish to participate.

Sponsors must apply to Health Canada for authorization to conduct a clinical trial.

Applying to conduct a clinical trial for COVID-19 purposes

Manufacturers of medical devices intended to treat COVID-19 can choose between 2 different processes to apply for a trial authorization:

The new Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (the Regulations), published in the Canada Gazette II on March 2, 2022, came into effect on February 27, 2022, following the repeal of the Interim Order No. 2.

The Regulations are a temporary measure. They will maintain the flexibilities and pathway set out by the interim order until the framework established through the Clinical Trials Modernization Initiative is in place. By reducing administrative burden, the Regulations will continue to:

Applications can be for clinical trials that assess:

Health Canada is prioritizing the review of all COVID-19 clinical trial applications received under both processes and has already authorized a number of trials.

For more information on how to apply to conduct a clinical trial using the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations process, see the guidance document on clinical trials for medical devices.

You can contact Health Canada to request a pre-clinical consultation before you submit your application. We are expediting discussions with applicants that have products in development and sufficient pre-clinical data.

For enquiries on clinical trials for COVID-19 medical devices, please contact

For information on drug and vaccine clinical trials for COVID-19, please visit our drugs and vaccines page.

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