The regulation of medical devices in Canada is governed by the Medical Devices Regulations, established under the authority of the Food and Drugs Act. These regulations outline the requirements for selling, importing, and advertising medical devices in the country. Health Canada, along with regulatory agencies in other countries, follows a lifecycle approach to regulate medical devices. This approach involves assessing the safety and effectiveness of devices both before and after they are authorized for sale.
To ensure continued monitoring of benefits and risks after a medical device is authorized for sale in Canada, two new requirements were introduced. These requirements are addressed in sections 25, 39, and 61.4 to 61.6 of the Medical Devices Regulations.
The first requirement involves the preparation, retention, and submission of summary reports, which provide a comprehensive assessment of new information on the benefits and risks of licensed Class II, III, or IV medical devices.
Class I devices are exempt from this requirement. Manufacturers of Class II, III, and IV devices must periodically complete summary reports as outlined in the regulations.
The second requirement pertains to issue-related analyses of safety and effectiveness. If there are concerns that a medical device authorized for sale in Canada may not meet safety and effectiveness requirements, Health Canada may request manufacturers of Class I, II, III, or IV devices to prepare and submit an analysis.
The scope of these requirements applies to medical device license holders, primarily manufacturers, including private label manufacturers.
Acceptable Information to Include:
Introduction or Cover Page:
The introduction or cover page of the summary report should include the following information:
- Date of the report
- Time period for which the report is being completed
- Device licence number and details (medical device, medical device group, medical device family, and/or medical device group family)
- Identifier(s), if applicable
- Name and address of the licence holder
- List of countries where the device(s) was/were distributed, sold, or available during the reporting period.
Summary of Changes to the Device or Licence:
This section provides a summary of changes that have occurred to the device or its authorization in Canada since the last summary report. It includes:
Changes made to the device or its labeling related to benefits or risks (e.g., design, intended use, contraindications)
Applications made to Health Canada for a licence amendment under section 34 of the Regulations related to benefits or risks
Recalls issued in Canada and outside of Canada pertaining to serious risks of injury to human health Changes to the information and documents supplied by the manufacturer as required by section 43(1)(b) of the Regulations.
In this section, the licence holder conducts a critical analysis considering the following elements:
Possible adverse effects associated with the use of the medical device
Problems related to performance or safety, including complaints received by the manufacturer, importer, or distributor.
Incidents concerning device failure, deterioration in effectiveness, inadequate labeling, or directions for use that have led to death, serious deterioration in health, or could do so if the incident reoccurred
Serious risks of injury to health relevant to the safety of the device
Misuse or off-label use of the device resulting in changes to the known benefits or risks associated with the device.
The analysis should consider factors such as the risk profile of the device, Canadian sales rates, data from other countries, and clinical evidence updates.
The conclusion section provides an overall assessment of the benefits and risks of the device. It includes:
- Determination of whether a change to the benefits or risks has occurred during the reporting period.
- Identification of any changes to the benefits or risks
- Mention of any preventive or corrective actions considered, implemented, or planned as a result of the identified change.
- Examples of changes that may be mentioned include reductions in benefits, increased likelihood or seriousness of risks, or identification of new risks.
Types of information to include in an issue-related safety and
Device complaints and incident reports:
Include information on complaints, incidents, and relevant data specific to the issue.
Include Canadian and international data, if applicable.
Clinical data and other evidence:
Include relevant clinical data from published sources, device-related investigations, and clinical study outcomes.
Include pre-clinical safety data, published scientific literature, and other supporting evidence.
Exposure data or sales data:
Provide data on device exposure, such as the number of units sold or procedures performed.
Tailor exposure data to the type of device, considering single-use devices or devices used multiple times.
Device malfunction trends, quality issues, and other analyses:
Include information on device malfunctions, quality issues, root cause analysis, and failure modes and effects analysis.
Assess the current labelling to determine if it provides necessary information for safe and effective device use.
Evaluate whether the labelling adequately communicates potential risks associated with the device.
Notifying Health Canada of a Change in Benefits or Risks:
If a change to the benefits or risks of the device is identified, the licence holder must notify Health Canada in writing within 72 hours.
Methods for notification include submission of a medical device licence amendment application, notification of a recall, or submission of the summary report itself.
The notification should clearly identify the significant change and include the most recently completed summary report.
Retention Time for Keeping Summary Reports:
The licence holder is required to retain copies of the summary reports and the information used to prepare them for 7 years.
The reports and supporting information should be kept onsite or easily accessible.
Data used for the reports should also be retained for 7 years for potential validation during inspections.
Overall, the guidance provides a structured approach for preparing summary reports, including identifying the device and licence, summarizing changes, conducting critical analysis, reaching conclusions, and notifying Health Canada of significant changes. The reports should be retained for a specified period, and compliance with these requirements is essential for medical device licence holders in Canada.
Timeframe for Submitting an Analysis:
The timeframe for submitting an analysis will be specified in the request from Health Canada.
The default timeframe is 30 calendar days from the date of the request, but it may be shorter if there is a need to determine if the device poses a serious and imminent risk to human health.
The analysis should be submitted electronically in either English or French to the designated email address provided by Health Canada.
Compliance and Enforcement:
Non-compliance with the request for analysis may result in compliance and enforcement measures by Health Canada.
Compliance and enforcement actions will follow the risk-based approach outlined in the compliance and enforcement policy for health products (POL-0001).
Failure to comply with a request for analysis may lead to suspension of the licence for Class II to IV devices and a directive to stop the sale of the device for Class I devices.
The guidance emphasizes the importance of providing a concise analysis addressing the specific issue raised by Health Canada and complying with the specified timeframe and reporting requirements. Non-compliance may result in regulatory actions to ensure the safety and effectiveness of medical devices in Canada.
In summary, the regulation of medical devices in Canada follows a lifecycle approach, with requirements outlined in the Medical Devices Regulations. The guidance document provides clarity and instructions for manufacturers to comply with the regulations, specifically concerning summary reports and issue-related analyses. These requirements aim to ensure the ongoing monitoring of benefits and risks associated with medical devices, contributing to the protection of public health and safety in Canada.
For a template of the Canada summary report, please feel free to contact QuARa conseil. We can provide you with a comprehensive template that aligns with the requirements of Health Canada’s Medical Devices Regulations.