A recent notice was published by Australia’s TGA details on the latest reforms to post-market monitoring of medical devices.
The TGA reporting forms system was updated in 2019 to improve monitoring and tracking of device incident reports, following feedback from stakeholders.
A report can be now lodged electronically, and previously reported incidents, initial reports, and follow-up reports can be updated with additional information. The status of reports can be reviewed and past reports can be viewed.
To complement these changes to the form, a guidance document for medical device incident reporting was published.