Health Canada collects post-market information from a wide variety of sources after products are approved for sale in the Canadian market, then evaluates information to come up with appropriate safety measures involving medical devices.
Signal detection and assessment
Health Canada continuously receives and evaluates Medical Devices Incident Reports and Post-Market Adverse Reaction Reports. Through the data collected, detection of new safety signals is possible which may warrant more safety investigations.
Health Canada publishes Summary Safety Reviews (SSRs) to inform the public of safety investigations that possibly affects the health products used.
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Mandatory Problem Reporting
Manufacturers and importers of medical devices are required to submit any reportable incident to Health Canada and failure to accurately do so could lead to financial penalties or criminal sentences. Reportable incidents are those occurring inside or outside Canada involving a medical device sold in Canada and that:
- Is related to device failure or deterioration of its efficacy, or inadequate labelling or directions for use
- Has led to serious health deterioration or death of a patient, user or other person,
- Could lead to serious health deterioration or death of a patient, user or other person if the incidents recur
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Preliminary report
With regards to incidents occurring inside Canada, a preliminary report must be submitted
- within 10 days after the manufacturer or importer becomes aware of the incident, if the incident has led to death or health deterioration of a patient, user or other person
- within 30 days after the manufacturer or importer becomes aware of the incident, if the incident has NOT led to death or health deterioration of a patient, user or other person, but could do so if the incident recurs
With regards to incidents occurring outside Canada must be reported as soon as possible after the manufacturer indicated to the regulating authority of the country where the incident occurred, that the manufacturer intends to take corrective action or after the regulating authority requires the manufacturer to take corrective action.
A preliminary report must contain the following information:
- name of the device and its identifier
- name and address of manufacturer and its importer; name, title, contact details of representative
- date which the incident came to the attention of manufacturer or importer
- details of the incident
- name, address, and contact details of the reporter of incident
- identity of other medical device or accessories involved in the incident
- manufacturer’s or importer’s preliminary comments regarding the incident
- course of action and investigation that manufacturer or importer will follow and timetable for completing proposed action and for submitting final report
- statement if previous report has been submitted regarding the medical device
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Final report
After submitting a preliminary report, a final report must be submitted within the proposed timetable mentioned in the preliminary report. A final report must contain the following information:
- description of the incident and the number of persons who experienced health deterioration or death
- detailed explanation of the cause of incident and rationalization for actions taken with regards to the incident
- actions taken resulting from investigation including:
- increased post-market surveillance of the medical device
- corrective and preventive action regarding the design and manufacture of the medical device
- recall of the medical device
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Risk Management Plan
Risk management plan helps Health Canada improve the quality of evaluation including measures for companies to take to identify, minimize, and prevent known or possible risks to patients or users. Identified risks will then be disclosed to healthcare professionals and to the public through Health Canada’s Recall and Safety Alerts Database.
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Recall
Before a recall of a medical device, the manufacturer and importer must provide the following:
- name and identifier of the medical device
- name and address of manufacturer and importer, name and address of establishment where the medical device was manufactured if different from manufacturer
- reason for recall, nature of defect or possible defects, date and circumstances which defects and possible defects where discovered
- evaluation of risk linked to defects and possible defects
- number of affected units of the medical device that the manufacturer or importer manufactured in Canada, imported to Canada, and sold in Canada
- period which the affected units of medical devices were distributed in Canada
- name of each person whom the affected units were sold to by manufacturer or importer, plus the number of units sold each person
- copy of any communication issued regarding the recall
- proposed strategy for conducting the recall, including date of start and completion of recall, and manner of progress information
- proposed action in preventing problem recurrence
- name, title, and contact details of manufacturer or importer’s representative
After completion of recall, the manufacturer or importer must report the results of the recall and the action taken in preventing problem recurrence.
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Health Products Advertising
Health Canada regulates the advertising of health products sold in Canada to ensure that companies do not make false claims. When advertising complaints are received, Health Canada reviews these complaints and take action, like halting the sale and advertisement of the product for instance.
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Updates
While manufacturers and importers are already required to submit incident reports, healthcare practitioners, hospitals, and patients/consumers are already encouraged to report any incident involving medical devices, starting February 2019. Health Canada is also currently developing an educational content and approach in helping hospitals and healthcare professionals identify reportable medical device incidents. Improvement of reporting from other healthcare facilities such as clinics is also on the works.
Also starting early in the year 2019, Health Canada will require medical device manufacturers to conduct studies, tests, and assessments. Health Canada will also require manufacturers to provide information addressing health risks or experience monitoring with their products. Manufacturers will be given 72 hours to notify Health Canada when other regulatory agencies issue warnings on serious risks related to the medical device. Information on label changes or license suspensions must also be submitted.
