Changes

While the language in the summary reporting provisions has been revised to be clearer, the intent is the same. As such, the requirements have not changed.

While the language in the summary reporting provisions has been revised to be clearer, the intent is the same. As such, the requirements have not changed.

To understand and comply with the regulatory requirements for summary reports, refer to our [https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/medical-device-reports-analyses-guidance.html guidance document].

To understand and comply with the regulatory requirements for summary reports, refer to our [https://www.canada.ca/en/health-canada/services/drugs-health-products/reports-publications/medeffect-canada/medical-device-reports-analyses-guidance/summary.html guidance document].