Guidance on applications for COVID-19 medical device clinical trials under the Regulations: Incidents, record keeping and recalls

On this page

• Reporting incidents
• Keeping records
• Recalls

Reporting incidents

The authorization holder of the COVID-19 medical device clinical trial must report to Health Canada within 10 days of becoming aware of all incidents (within and outside of Canada) that:

• are related to a failure of device or a deterioration in its quality or effectiveness, or any inadequacy in its labelling or in its directions for use or
• have led to the death or a serious deterioration in the state of health of a patient, user or other person, or could do so were it to recur

When submitting the incident report, follow the procedure outlined in the appropriate problem reporting form:

• Mandatory medical device problem reporting form for industry
• Medical device problem reporting form for health care professionals

Clearly state in the report that the device was approved under these Regulations.

You should submit an incident report to Health Canada even if the clinical trial was terminated prematurely.

Keeping records

The authorization holder must keep records to confirm that the clinical trial has been conducted in accordance with the Regulations. You must keep these records for a minimum of 15 years, beginning with the last visit of the last participant in Canada. This includes information referred to in section 4(2) of the Regulations.

This requirement continues to apply to former authorization holders who have had their authorizations revoked in whole.

Health Canada will require this information if there's an issue.

Note: The retention period applies to device clinical trials previously authorized under IO No. 2, as well as to all new clinical trials authorized under the MDR.

Distribution records

The authorization holder must keep distribution records for COVID-19 medical devices that are imported, sold or used in a clinical trial, in a manner that would allow for their timely retrieval. The records should be kept while the IO is in force, as per the MDR, in case the device needs to be taken off the market quickly if there's an issue.

Complaint handling

The authorization holder must keep records on how complaints have been handled. You must keep these records for a minimum of 15 years, which would begin with the last visit of the last participant in Canada.

The holder must also develop, maintain and implement procedures to:

• investigate problems in a timely manner related to the device's performance or safety (includes consumer complaints)
• ensure effective and timely recall of the device

Recalls

Authorization holders must be proactive and notify Health Canada on or before they recall a COVID-19 medical device in Canada. To recall a device used in a clinical trial, follow the same procedure outlined in the Guide to recall medical devices (GUI-0054).

You must then notify Health Canada of the results of the recall and actions taken to prevent the issue from occurring again.

The importer of the COVID-19 medical device may submit this information on behalf of the authorization holder if the information that the holder and importer submit are identical. However, the holder must advise us that they have permitted the importer to provide all information on their behalf.