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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.
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:
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.
Here are the basic steps you should follow in reporting an adverse event in 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:
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.
Please contact us for more information on how we can assist you with medical device vigilance reporting for Canada.