MedTechbloggen har tidigare beskrivit några av de guidelines som Health Canada givit ut.
”I am pleased to inform you that Health Canada has finalized the guidance document entitled ”Mandatory Problem Reporting for Medical Devices (GUI-0059)”, which is now available on Health Canada’s Compliance and Enforcement website under ”What’s New”.
This guide replaces the policy aspect of the current GUI-0055 document entitled ”Mandatory and Voluntary Problem Reporting for Medical Devices”, which was published in January 2003 and contains both policy and guidance elements. It also states the requirements and responsibilities regarding medical device compliance and enforcement in Canada, in accordance with the regulatory requirements of the Food and Drug Act and Medical Devices Regulations.”
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