·         Objective: Enhance understanding of "significant change" in Medical Devices Regulations, aiding manufacturers of Class III or IV devices in Canada.

·         Application: Helps identify changes needing amended medical device authorization, covering aspects like design, manufacturing, safety, and effectiveness.

·         Process: Outlines a structured approach for assessing changes, ensuring compliance before marketing modified devices.

·         Support: Provides examples distinguishing significant from non-significant changes, with contact info for further assistance.

🔗 Original: https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices/application-information/guidance-documents/interpret-significant-change-medical-device.html