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:

As of May 23, 2020, the new interim order process expands the range of sponsors who may apply for a medical device clinical trial authorization. With this process, independent researchers and clinicians, for example, can also apply to sponsor a trial. The interim order process is also more flexible with respect to the application format and some administrative requirements, without compromising patient safety or validity of trial results.

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 interim order 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 hc.it-ee.sc@canada.ca.

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

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