New guidance for medical devices
by Health Canada
Health Canada has issued guidance on summary reports to implement a lifecycle approach to the regulation of medical devices in Canada.
Health Canada has issued a guidance on Summary reports and issue-related analyses for medical devices to help medical device manufacturers comply with sections 25, 39 and 61.4 to 61.6 of the Medical Devices Regulation. Two new requirements have been added to the regulation to help identify changes to what’s known about the benefit/risk ratio of medical devices on the market in Canada.
A summary report is a comprehensive assessment of new information on the benefits and risks of a licensed Class II, III or IV medical device. The guidance document clarifies Health Canada’s expectations on the preparation of summary reports.
A summary report is required for each medical device separately and is to be submitted by the license holder, usually the manufacturer. Health Canada may also ask manufacturers of a Class I, II, III or IV medical device to prepare and submit an issue-related analysis if deemed appropriate.
The time frame for the reporting requirements is:
Class I devices: No requirement for Summary reports
Class II devices: Every 2 years with information for previous 24 months,
Class III and IV devices: Yearly with the information for previous 12 months.
The reporting period is not tied to the anniversary date of a medical device license. License holders may choose the reporting period for the report if the report falls within the required reporting timeframe. This means that the above reporting requirement can be combined with the creation of the PSUR for EU.
Note that the retention time for summary reports including the underlying statistical data is at a minimum 7 years.
The additions to the regulation will come into force 23 Dec 2021 so it is important to have procedures in place even if the reporting is not due until 24 months. Auditors will ask about your preparedness for the new requirements.
Link to guidance: Guidance on summary reports and issue-related analyses for medical devices.
by Health Canada