A Periodic Summary Reports is a comprehensive assessment of new information on the benefits and risks of a licensed Class II, III or IV medical device. Summary Reports are required by Health Canada for all medical devices. The reporting timeline for medical device licence holders Class II devices is every 2 years (first report is due Dec 31, 2023) with information gathered during the previous 24 months and for Class III and IV devices, it is every year (due by Dec 31, 2022) with information gathered during the previous 12 months. An elaborate report summarizing new cumulative safety and effectiveness knowledge gained during the reporting period should be compiled. If no changes to the benefits and risks are observed since the previous reporting period, the compilation of a summary report is not required.
If Health Canada determines that a medical device authorized for sale in Canada does not meet safety and effectiveness requirements, manufacturers of a Class I device, and the medical device licence holders of Class II to IV medical devices are requested to prepare and submit an issue-related analysis. Device complaints and incident reports, clinical data and other evidence, exposure data or sales data, device malfunction trends, quality issues, labelling and conclusion must be included in the assessment reports. The default timeframe for submitting an analysis is 30 calendar days from the date of the request unless specified otherwise by the Minister.
If you need any help drafting these reports, contact us and we’ll happily assist you.
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