What Must Be Reported
What constitutes an adverse event or near adverse event requiring mandatory reporting to the TGA by Australian medical device sponsors.
Reporting Timeframes
Mandatory timeframes for sponsors to submit initial and follow-up adverse event reports to the TGA under Australian medical device regulations.
How to Report (IRIS)
How to submit an adverse event report to the TGA through the IRIS system, including the sponsor reporting portal and what the TGA does with reports.
Exemptions from Reporting
Circumstances in which sponsors are not required to report an adverse event to the TGA, and important limitations on these exemptions.