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Latest reforms to Post-Market Monitoring of Medical Devices- Australia’s TGA

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.

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