Tag: adverse event reporting

3
Jun

Global Adverse Event Databases

The United States Food and Drug Administration Mandatory Reporting According to Applicable Regulations Drugs and Biologics Drugs – FDA Adverse Event Reporting System (FAERS) Data Files Devices Medical Devices – MAUDE (Manufacturer and User Facility Device Experience) Vaccine Adverse Event Reporting System Australia – Therapeutic Goods Administration Database of Adverse Event Notifications (DAEN) The Therapeutic Goods Administration (TGA) receives adverse event reports associated with

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24
Jun

Medical Device Adverse Event Reporting in EU, Health Canada and FDA

By Regulatory Doctor; LinkedIn; Google Plus; Twitter Here is a list of applicable guidances from EU Commission, Health Canada and US FDA.  The following will be helpful when you establish and maintain your adequate procedures for reporting medical device adverse events in EU, Canada and US. European Union (EU) EU MEDDEV 2.12/1 Rev 8, January 2013 Health Canada 2011 October Health Canada Mandatory

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