Guidance on summary reports and issue-related analyses for medical devices. : H164-309/2026E-PDF

"This guidance document was prepared to help medical device manufacturers understand and comply with sections 25, 39, 61.4 to 61.6 and 68.31 to 68.33 of the Medical Devices Regulations (regulations). Two requirements in the regulations were added to ensure the continued monitoring of benefits and risks after a product is authorized for sale in Canada. The 2 requirements concern: the preparation, retention and submission of summary reports (sections 61.4 to 61.6 and 68.31 to 68.33 of the regulations); the completion of issue-related analyses of safety and effectiveness (subsection 25(1) and sections 39 and 68.23 of the regulations). This guidance document: clarifies Health Canada's expectations for the preparation of these summary reports and issue-related analyses; gives an overview of the requirements and procedures for submitting summary reports and issue-related analyses to Health Canada. …"-- Purpose of the guidance document, pages 1-2.

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publications.gc.ca/pub?id=9.960789&sl=1

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