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.
- Publisher - Current Organization Name: Health Canada
- Licence: Open Government Licence - Canada
Data and Resources
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Guidance on summary reports and issue-related analyses for medical devices: OverviewHTMLEnglish publication HTML
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Guidance on summary reports and issue-related analyses for medical devices: OverviewHTMLFrench publication HTML
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