Guidance on summary reports and issue-related analyses for medical devices: Issue-related analyses of safety and effectiveness

Name: Guidance on summary reports and issue-related analyses for medical devices: Issue-related analyses of safety and effectiveness
Creator: Health Canada
License: https://open.canada.ca/en/open-government-licence-canada

This guidance document was prepared to help medical device manufacturers understand and comply with the Medical Devices Regulations. Two new requirements in the Regulations were added to ensure the continued monitoring of risks after a product is authorized for sale in Canada.

Publisher: Health Canada
Resources: 2
Catalogue metadata updated: 2024-03-30

Data overview

Formats: HTML
File languages: English, French

Official sources and licences

Government of Canada Open Data
Open Government Licence – Canada

Resources

Guidance on summary reports and issue-related analyses for medical devices: Issue-related analyses of safety and effectiveness (English, HTML) HTML
Guidance on summary reports and issue-related analyses for medical devices: Issue-related analyses of safety and effectiveness (French, HTML) HTML

Related open data

Health Canada