Health Canada Issues Guidance on Postmarket Reports
Health Canada has issued guidance outlining what it expects from devicemakers in their postmarket “summary reports,” a new requirement recently added to Canadian regulations.
The agency defines a summary report as “a comprehensive assessment of new information on the benefits and risks of a licensed medical device.”
For the summary reports, device license-holders must periodically analyze information received about the use of their devices, including adverse events and problems reported to the manufacturer, importer or distributor related to performance characteristics or safety.
License-holders of Class III and Class IV devices should file summary reports every year, while license holders of Class II devices should prepare summary reports every two years. Makers of Class I devices do not need to submit summary reports, the agency said.