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Changes to the visibility of suspended medical devices
Changes are coming to the visibility of the suspended medical devices, including IVDs. After these changes are implemented, the suspended medical devices will not be visible in the ARTG database on the TGA web site, as this is a list of goods that can be lawfully supplied. In addition, the ARTG certificate and record summary of the suspended medical device will be watermarked as 'Suspended'. These changes, at this stage, will not be applied to medicines.
Database for suspensions
The TGA maintains two databases listing suspensions from the Australian Register of Therapeutic Goods (ARTG) based on the different circumstances in which the suspension occurs and the kind of therapeutic goods involved.
To find out whether a product is currently authorised for supply in Australia, check the ARTG.
Effect of suspension
Once suspended, the goods are taken not to be included in the ARTG while the suspension has effect. The therapeutic good cannot be imported, manufactured or exported from Australia by the sponsor for the duration of the suspension. The Secretary can revoke or extend a suspension.
Review of a suspension by a delegate of the Minister
Under section 60 of the Act, a person whose interests are affected by a decision of the Secretary to suspend the entry of therapeutic goods from the ARTG, can, within 90 days, request an internal review of the decision by the Minister for Health. A person can also seek a review by the Administrative Appeals Tribunal (AAT) of the decision by the Minister on the internal review.
The Secretary is required under the Act to publish particulars of any decision by the delegate of the Minister that overturns a decision to suspend a product from the ARTG. Information about any such reviews of a suspension is the database under 'Decision status'.
Records of individual decisions
The database contains records of compliance decisions that the Secretary is required under the Act to publish. If a delegate of the Minister decides to revoke the suspension, the information about both the initial and review decisions are required to remain available to the public. It is for this reason that details about all decisions will remain in the database.