Hi Karen!
Yes, they must report to both. It's in section 2.4.5 of this guidance: Applications for Medical Device Investigational Testing Authorizations Guidance Document
2.4.5 Mandatory problem reporting
The qualified investigator is required to report serious adverse events to Health Canada and to the manufacturer and importer within 72 hours of discovery. This includes cases in which the incident:
- is related to a failure of the device or a deterioration in its effectiveness, or any inadequacy in its labelling or in its directions for use, and
- has 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
For an incident that occurs in Canada, the manufacturers and importers are required to provide a preliminary and a final report in respect of the incident. The preliminary report shall be submitted:
- within 10 days after the manufacturer or importer of a medical device becomes aware of an incident, if the incident has led to the death or a serious deterioration in the state of health of a patient, user or other person, or
- within 30 days after the manufacturer or importer of a medical device becomes aware of an incident, if the incident has not led to the death or a serious deterioration in the state of health of a patient, user or other person, but could do so were it to recur.
Further details for the information required in the reports, as well as reporting for incidents outside of Canada can be found in sections 59 to 62 of the Regulations. Manufacturers may reference the Guidance Document for Mandatory Problem Reporting for Medical Devices and relevant forms (refer to Appendix 2) for the process of submitting these reports.
------------------------------
Karen Long RAC
Vancouver BC
Canada
------------------------------
Original Message:
Sent: 12-Aug-2019 15:03
From: Karen Zhou
Subject: Reporting of clinical investigation incidents to Health Canada - Healthcare professionals
Hello,
In Canada, are healthcare professionals required to report clinical investigation incidents to Health Canada? I know they are required to report to the manufacturer. But for serious adverse events related to the device, are they required to report to Health Canada separately? From the form below, it looks like they have to, but it's not specified anywhere in the guidance or in the regulations. Thanks. Please clarify my understanding.
https://www.canada.ca/content/dam/hc-sc/documents/services/drugs-health-products/medeffect-canada/adverse-reaction-reporting/mandatory-reporting-hospital-device-eng.pdf
------------------------------
Karen Zhou
------------------------------