Guidance on applications for COVID-19 medical device clinical trials under the Regulations: Post-authorization requirements

On this page

• Submitting an amendment to a clinical trial authorization
• Suspending a clinical trial
• Discontinuing a clinical trial
• Revoking a clinical trial authorization
• Importation

Submitting an amendment to a clinical trial authorization

You must amend a clinical trial authorization if:

• you have made significant changes to any information submitted to the Minister (section 4(2) of the IO) or
• we have requested more information (section 10)

For examples of significant changes, please refer to section 2.5 of the following guidance document:

• Applications for medical device investigational testing authorizations

For all amendment applications, the applicant's senior official should complete, sign and date the following form:

• Application form for an amendment to a medical device clinical trial under the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations (PDF)

You do not need to amend an authorization if you are:

• adding or removing an institution where the trial is being conducted or
• changing the list of qualified investigators

You may implement these 2 changes immediately. You do not need to submit these changes to Health Canada, but be sure to keep records of such changes on file.

Note: Any application to amend an authorization that was outstanding when IO No. 2 was repealed is considered an application under the Regulations.

Suspending a clinical trial

Health Canada may suspend, in whole or in part, the authorization of a clinical trial under the Regulations at any time.

For example, we have the ability to suspend an arm, or treatment group, of a multi-arm trial, if needed. The rest of the trial would proceed, ensuring that other patients can continue to receive a promising therapy.

We may take this action if we have reasonable grounds to believe that:

• any of the requirements of the original authorization are no longer being met
• the requested information was not submitted in the time, form and manner requested or
• the authorization holder has contravened the Regulations or the Food and Drugs Act

Note: All suspensions, in whole or part, for clinical trials issued under IO No. 2 will remain in effect under the Regulations. As indicated in the Regulations, you must also keep all records, even if your authorization is suspended or revoked.

Reinstatement

Health Canada must reinstate a suspended trial if the holder of the suspended authorization provides the required information or material in the time, form and manner specified. The information must demonstrate that the situation that gave rise to the suspension did not exist or has been corrected.

Additional information and material

We may request more information, materials or samples when deciding whether to issue, amend or suspend a COVID-19 medical device clinical trial authorization. You must provide this information within the timeframe, form and manner specified by us.

Note: A request made by Health Canada under IO No. 2 continues to be in effect under the Regulations.

Discontinuing a clinical trial

The authorization holder must notify Health Canada in writing as soon as possible, but no later than 15 calendar days, if a COVID-19 clinical trial, in whole or part, has been discontinued or closed.

All qualified investigators must also be informed in writing.

As well, the holder must stop importing or selling the device at each clinical trial site at which the trial has been discontinued. After the clinical trial is finished, you should return re-usable devices, such as capital equipment, that are not yet licensed, to the manufacturer or importer.

For information on what to include in the notification, please consult the following guidance document:

• Applications for medical device investigational testing authorizations

If the authorization holder discontinues and then wants to resume their trial, they have to refile a new clinical trial application.

Note: A notice of discontinuance provided to Health Canada in IO No. 2 continues to be in effect under the Regulations.

Revoking a clinical trial authorization

Mandatory revocation

When we receive a notice of discontinuance, we must cancel, in whole or in part, the authorization for importing or selling the COVID-19 medical device used for the clinical trial.

Discretionary revocation

We may cancel, in whole or in part, the authorization for importing or selling COVID-19 medical devices for the purpose of clinical trials at any time. We will do this if the authorization holder fails to provide satisfactory information following a suspension.

Failure to provide satisfactory information includes the following examples:

• the requested information under section 9(2) of the Regulations has not been provided in the specified timeframe
• Health Canada determines the information does not demonstrate that the situation giving rise to the suspension did not exist or has not been corrected

Notice/transparency of revocation

Following a mandatory or discretionary cancellation, we will issue a cancellation letter to the authorization holder. We will either confirm receipt of notice of discontinuation (mandatory cancellation) or give reasons for the cancellation (discretionary cancellation).

Note: A COVID-19 medical device authorization that was revoked in part by Health Canada under IO No. 2, and has not been revoked in whole since, will continue to be revoked in part under the Regulations.

Importation

Each shipment of a COVID-19 medical device imported into Canada must be accompanied by a copy of the authorization to import. We will issue this document to the applicant upon authorization.