Health Canada Adverse Event Reporting for Medical Devices

ANSWERED ON THIS PAGE:

• When do we need to report an adverse event to Health Canada?
• What is the medical device adverse event reporting process in Canada?
• Are we required to report adverse events that occurred outside of Canada?

According to Canada's Food and Drugs Act, medical device manufacturers or importers must submit incident reports to Health Canada. This is referred to as Mandatory Problem Reporting (MPR).

Canada's Medical Devices Regulations SOR-98-282 (CMDR) and Guidance Document for Mandatory Problem Reporting for Medical Devices offer valuable information on terminology, timelines and other vigilance reporting requirements in Canada.

Companies that fail to accurately report incidents to Health Canada could face financial penalties or, in extreme scenarios, criminal sentences. Ignorance of the Law and Regulation is not an acceptable excuse for not implementing a vigilance system for Canada. It is critical that you are proactive.

When are adverse event reports required by Health Canada?

Manufacturers and importers are both required to inform Health Canada of any reportable incidents and file a Preliminary and Final Report. Incident must be reported if a medical device is sold in Canada and the incident relates to a failure of the device or a deterioration in its effectiveness, inadequacy in its labeling or directions for use, and has contributed to one or more of the following outcomes:

• Death of a patient, user or other person
• Serious deterioration in health of a patient, user or other person
• Potential for death or serious deterioration in health of a patient, user or other person if the incident were to recur

If corrective action is necessary, Health Canada must be informed in a Preliminary Report. Your report should include a corrective action strategy, such as a temporary stop-sale or recall, in addition to plans for communicating incident information to consumers.

Incidents that occur outside Canada involving the same devices sold in Canada must also be reported if a corrective action is deemed necessary either by the manufacturer or the local regulator.

Canada's medical device reporting process

Here are the basic steps you should follow in reporting an adverse event in Canada:

• Refer to your written Standard Operating Procedure / Quality System Procedure
• Reference Canada's Medical Device Regulations, SOR-98-282, and Guidance Document for Mandatory Problem Reporting for Medical Devices for the correct reporting timeline, which will depend on the severity of the incident.
• Submit a Preliminary Report to Health Canada detailing the incident and corrective action strategy.
• Distribute a corrective action notification to consumers if approved by Health Canada.
• Submit a Final Incident Report to Health Canada justifying any corrective or preventative actions you have taken, including any investigation results.
• Add all reports, along with any correspondence with Health Canada, to your Quality Management System records.

How can Emergo help with adverse event reporting for Health Canada?

We have established excellent relationships with Health Canada and are very familiar with handling vigilance issues and incident reporting in Canada. Working with Emergo offers you the following benefits:

• We can assist in submitting incident reports and corrective action information to Health Canada on your behalf.
• Our in-depth knowledge of Canadian medical device regulations ensures that your vigilance procedures will always be up-to-date.
• Our experienced Canadian consulting team can help you determine when incidents are reportable and ensure that required vigilance reports are completed on time.
• We have experience assisting hundreds of manufacturers with post-market surveillance, Health Canada Medical Device License approvals and other regulatory consulting services.

If you do not have the required documented procedure for incident reporting which specifically addresses the requirements of Health Canada's Mandatory Problem Reporting or if you are concerned that your existing documented procedure is not in compliance with the CMDR and the issued Health Canada guidance, we can help.