Medical devices for COVID-19: Conducting a clinical trial

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• Clinical trials regulations
• Applying to conduct a clinical trial for COVID-19 purposes

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:

• may be used for another purpose or
• is not yet available in Canada

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:

• process for investigational testing outlined in the Medical Devices Regulations or
• process outlined in the new interim order for clinical trials for medical devices and drugs related to COVID-19

On May 3, 2021, the Minister of Health signed a second interim order for clinical trials for medical devices and drugs related to COVID-19. This new interim order replaces the original signed on May 23, 2020.

The 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:

• existing, marketed products in Canada as COVID-19 therapies or
• new COVID-19 therapies currently under development

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 it-ee@hc-sc.gc.ca.

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

Related links

• Notice for industry: Ensuring predictability for interim orders relating to COVID-19
• Joint Statement on Clinical Trial Oversight in Canada
• Interim order respecting clinical trials for medical devices and drugs relating to COVID-19: notice
• Applications for COVID-19 drug and medical device clinical trials under the interim order: notice release of guidance documents
• COVID-19 health products industry
• COVID-19: For health professionals
• Drugs and vaccines for COVID-19