ARCHIVED Guidance on applications for medical device clinical trials under the interim order: Incidents, record keeping and recalls
Notice to Reader:
We have replaced the Interim Order No. 2 respecting clinical trials for medical devices and drugs relating to COVID-19. See the regulations notice about the Clinical Trials for Medical Devices and Drugs Relating to COVID-19 Regulations.
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The holder of the COVID-19 medical device clinical trial authorization 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 Mandatory Medical Device Problem Reporting Form for Industry. The report should clearly state that the device was approved under this interim order.
The authorization holder should submit an incident report to Health Canada even if the clinical trial was terminated prematurely.
The authorization holder must keep records to confirm that the clinical trial has been conducted in accordance with the interim order for as long as the IO is in force. This includes information referred to in section 4(2) of the IO.
The qualified investigator should also keep these records should Health Canada require this information if an issue arises.
The authorization holder must keep distribution records for COVID-19 medical devices that are imported, sold or used in a clinical trial. The records must be kept while the IO is in force in the event the device needs to be quickly taken off the market should an issue arise.
The authorization holder must keep records on how complaints have been handled.
The holder must also develop, maintain and implement procedures to:
- investigate problems in a timely manner related to the performance characteristics or safety of the device, including any consumer complaints
- ensure effective and timely recall of the device
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).
Afterwards, the holder must notify Health Canada of the results of the recall and actions taken to prevent the issue from recurring.
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 is required to advise Health Canada that they have permitted the importer to provide all information on their behalf.
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