Notice of updated guidance: Applications for COVID-19 medical device clinical trials under the Regulations 

The Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (the Regulations) were published on March 2, 2022, and came into effect on February 27, 2022. This follows the repeal of Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19, which was published on May 3, 2021.

The flexibilities under the interim order (IO) will continue under the Regulations. This approach will ensure that:

Health Canada has updated and renamed the guidance document that was created for interim orders No. 1 and No. 2 for COVID-19-related clinical trials. The new name of this document for medical devices is the Guidance on applications for COVID-19 medical device clinical trials under the Regulations.

Note: This notice excludes drugs. A separate notice of intent and guidance on applications for COVID-19 clinical trials for drugs is available:

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Purpose

The Regulations make it possible for COVID-19 medical device and drug clinical trials to continue under a flexible regulatory pathway.

The updated guidance document has information and guidance for:

Scope

The guidance document applies to COVID-19 clinical trials for medical devices. It also applies to applicants and authorization holders of COVID-19 medical device clinical trials under IOs No. 1 and No. 2.

For non-COVID-19-related clinical trials and those outside the scope of the Regulations, the Medical Devices Regulations (MDR) and related guidance continue to apply.

What the Regulations mean for applicants

The Regulations maintain all the flexibilities that were available through the repealed IOs No. 1 and No. 2. Some of these flexibilities include:

The reduced administrative burden that was in place under IOs No. 1 and No. 2 is also maintained.

What's new in the Regulations

The Regulations continue the optional pathway that was in place under IO No. 2 for COVID-19 medical device clinical trials. It ensures that all authorizations, suspensions and exemptions for clinical trials issued under IOs No. 1 and No. 2 remain in effect. This includes any terms and conditions.

The Regulations provide a more flexible authorization and implementation pathway for the clinical trials of drugs and medical devices involving human subjects in relation to diagnosing, treating, mitigating or preventing COVID-19.

Implementation

The provisions of IO No. 2 will expire on May 3, 2022. They will be replaced by the Regulations in advance of this date, on February 27, 2022.

The Regulations are a temporary measure until the framework established through the Clinical Trials Modernization Initiative is in place.

Applicants of COVID-19 medical device clinical trials may apply for authorization under either:

Once applicants apply for authorization under the Regulations, they must proceed with that pathway.

Trials already under way (authorized under the MDR) or new trials submitted under the MDR, and not authorized under IO No. 2 cannot be transitioned under the Regulations. These trials must follow the regulations under which they were originally submitted.

Contact us

For more information about this notice, please contact Health Canada's Medical Devices Directorate at meddevices-instrumentsmed@hc-sc.gc.ca.

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