Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

I am looking for confirmation I am correctly interpretting Canada's incident reporting requirement for Class I devices when the incident occurs outside of Canada. Is an incident report only required if the criteria of an incident are met AND corrective action has been indicated by the manufacturer in the foreign jurisdiction/mandated by the regulatory authority within that jurisdiction? 

Hello Anon,

Assuming you have looked through the guidance document: https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/incident-reporting-medical-devices-guidance-2021.html.  I am assuming you are referring to section 2.3.2 because the wording is confusing.  As I read the text, if the incident has occurred outside Canada and corrective action already taken, then no incident reporting needs to be made.  When the specific incident occurs than it does need to be reported.  Basically the answer is yes - but Health Canada only wants one specific incident reported - not all the 10 or 20 incidents which occurred along with what required the corrective action.  Hope that helps to clarify.

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Richard Vincins ASQ-CQA, MTOPRA, RAC
Vice President Global Regulatory Affairs
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Original Message:
Sent: 24-Oct-2022 14:12
From: Anonymous Member
Subject: Clarification on Reporting Incidents Occurring Outside Canada

This message was posted by a user wishing to remain anonymous

I am looking for confirmation I am correctly interpretting Canada's incident reporting requirement for Class I devices when the incident occurs outside of Canada. Is an incident report only required if the criteria of an incident are met AND corrective action has been indicated by the manufacturer in the foreign jurisdiction/mandated by the regulatory authority within that jurisdiction?

Incident reporting to Health Canada is required for a Canadian Class I device incident that occurred outside Canada only if BOTH of the following criteria are met:

a) the incident meets the incident criteria of Sections 59(1)(a) and (b);

b) for said incident occurring outside Canada, the manufacturer has indicated, to a regulatory agency of the country in which the incident occurred, the manufacturer's intention to take corrective action, or unless the foreign regulatory agency has required the manufacturer to take corrective action.

This is echoed by Health Canada's guidance document section 2.3.2.

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Kevin Randall, ASQ CQA, RAC (Canada, Europe, U.S.)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 24-Oct-2022 14:12
From: Anonymous Member
Subject: Clarification on Reporting Incidents Occurring Outside Canada

This message was posted by a user wishing to remain anonymous

I am looking for confirmation I am correctly interpretting Canada's incident reporting requirement for Class I devices when the incident occurs outside of Canada. Is an incident report only required if the criteria of an incident are met AND corrective action has been indicated by the manufacturer in the foreign jurisdiction/mandated by the regulatory authority within that jurisdiction?