Canada – Guidance on summary reports and issue-related analyses for medical devices: Overview

This guidance document was prepared to help medical device manufacturers understand and comply with sections 25, 39 and 61.4 to 61.6 of the Medical Devices Regulations. Two new 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)
  • the completion of issue-related analyses of safety and effectiveness (sections 25(1) and 39)

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…