RegDesk Regulatory Roundup

Jul 6, 2021

Health Canada on Incident Reporting: Timelines and Content

Health Canada, the country’s regulating authority in the sphere of medical devices, has published a guidance document dedicated to incident reporting under the new regulatory framework, which becomes effective from June 23, 2021. The document provides additional...

FDA: Adverse Event Reporting for EUA Medical Devices

Jun 16, 2020

COVID-19

FDA: Adverse Event Reporting for EUA Medical Devices

The Food and Drug Administration (FDA or the Agency) issued detailed guidelines dedicated to adverse event reporting rules for medical devices placed on the market under the Emergency Use Authorization (EUA). The EUA is a special regulatory framework implemented by...

RegDesk Regulatory Roundup

Health Canada on Incident Reporting: Timelines and Content

FDA: Adverse Event Reporting for EUA Medical Devices

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