How to prepare a Post-Market Surveillance Summary Report

Preparing a Post-Market Surveillance Summary Report Video

Reporting Timelines for Summary Reports

Timelines for Summary Reports are dependent upon the classification of the device in CANADA! Device Class I, II, III, or IV may mean other things in other jurisdictions. The bullets below outline the reporting timelines for the Medical Device License Holder to submit a summary report to Health Canada in.

• Class I Devices– Are exempt from summary reporting requirements
• Class II Devices– Must submit a summary report every two years with information gathered from the previous twenty-four months
• Class III Devices– Must submit an annual summary report
• Class IV Devices– These devices follow the same timeline as Class III, and the device license holder must submit an annual summary report

Summary Reports can be submitted to Health Canada by email to their device licensing contact address linked below. Both the Summary Report and any Notification of Changes must be provided in English or French.

devicelicensing-homologationinstruments@hc-sc.gc.ca

Within the summary report also be sure to include any preventive or corrective actions that have already been taken in response to the change in benefit/risk and whether Health Canada has already been notified via a license amendment or recall notification.

Record Retention Periods

The License Holder also has the responsibility for maintaining both a copy of the summary report and the information used to generate the summary report for at least 7 years. This is done in the event that statistical analyses need to be validated. These reports are also subject to inspection by Health Canada Inspectors.

It will be important to make sure that your Quality Management System captures this minimum record retention period appropriately. Especially because this is not just a copy of the report, but the data you used to create the report as well.

As an example, in the U.S.A the U.S. FDA requires the following record retention period under 21 CFR 820.180 General Requirements of Subpart M, Records, “(b) Record retention period. All records required by this part shall be retained for a period of time equivalent to the design and expected life of the device, but in no case less than 2 years from the date of release for commercial distribution by the manufacturer.”

This can cause confusion when dealing with quality management systems that address more than one authority having jurisdiction. The minimum 2 year retention period from the FDA may not meet the 7 year requirement from Health Canada depending on the type of device manufactured. On top of that the PMS Summary Report submitted to Health Canada is not a record required under the QSR (21 CFR 820) by the U.S. FDA.