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Following a review by the TGA, medical device entries (including IVDs) can be cancelled from the Australian Register of Therapeutic Goods. These cancellations are made by the Secretary under section 41GK, 41GL, 41GM and 41GN of the Therapeutic Goods Act 1989.
Where other actions are taken in relation to safety, the TGA will generally publish additional information about the issue on its alerts page.
The reasons for a cancellation are stated in the database below under 'Grounds for cancellation'.
The heading 'Decision status' provides updated information about cancellation decisions, for example information about any decision to revoke a cancellation decision. It will not appear in every entry.
To find out whether a product is currently authorised for supply in Australia, check the ARTG.
For cancellations that result in only one or more medical devices of a kind being cancelled and not the entry removed from the ARTG, see:
- Medical devices and IVDs: Cancellations of certain devices within an entry
- Medical devices and IVDs: Cancellations requested by the sponsor of certain devices within an entry
For cancellations of face masks following post-market review, see: Post-market review of face masks: Cancelled ARTG entries