Medical devices (including IVDs) can be suspended from the Australian Register of Therapeutic Goods following a review by the TGA. These suspensions are made by the Secretary under section 41GA of the Therapeutic Goods Act 1989.
Medical devices and IVDs can also be suspended from the ARTG if the conformity assessment certificate applying to that kind of device is suspended under section 41GF.
If a suspension occurs because of a safety concern, the TGA considers whether other actions including a recall are necessary and takes those actions when required. Any related safety alerts will appear under 'Further information'.
The reasons for a suspension are stated in the database under 'Grounds for suspension'.
The heading 'Decision status' provides updated information about a suspension, for example, a decision to extend the suspension, or information about any decision to revoke a suspension decision. It will not appear in every entry.
Changes to the visibility of suspended medical devices
From 16 September 2021, the visibility of suspended medical devices in the ARTG database has changed, with the suspended medical devices no longer visible in the ARTG database on the TGA web site . The suspended medical device is not visible as it cannot be lawfully supplied. In addition, the ARTG certificate and record summary of the suspended medical device will be watermarked as 'Suspended'. Sponsors of a suspended medical device will not be able to submit an application to vary their medical device entry or transfer the ARTG entry to another sponsor whilst the medical device remains suspended.