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Notice to sponsors of medical devices transferring existing registered and listed device entries

July 2007

Medical device sponsors seeking approval for an inclusion of a medical device that has previously been entered on the Australian Register of Therapeutic Goods (ARTG) as a registered or listed therapeutic device do not need to pay annual charges for both entries in the same financial year.

Annual charges are imposed by Regulation under the Therapeutic Goods (Charges) Act 1989 and provides that an annual charge is payable for all entries on the ARTG that is in force at any time during the year.

This year, a separate invoice for annual charges will be issued to Sponsors for the registered and listed device entered on the ARTG as at 1 July 2007. To avoid the potential of paying two annual charges for the same medical device, sponsors will be asked to identify existing registered/listed medical device which they are planning to transition to the new medical devices regulatory scheme and not pay annual charges for the old entries.

  • Where the inclusion is subsequently approved, a new invoice will be issued for the new entry and the previous registered and/or listed annual charges invoices will be cancelled.
  • Where a valid application has not been made to the TGA by 4 October 2007 for the transition of listed and/or registered devices (except tampons, disinfectants invitro diagnostics and devices of human origin) to the new medical devices regulatory scheme, companies will be required to pay their invoice by due date of invoice.

Sponsors planning to convert existing registered/listed medical devices entries before 4 October 2007should identify the relevant devices on their invoice and notify TGA Revenue Manager.

Facsimile 02 6232 8222
Email to

Sponsors should note that invoices for registered or listed therapeutic devices entries not paid by the due date as mentioned above will be cancelled for non-payment from the ARTG, whether or not the included therapeutic device entry has been approved. Details of such cancellations will be published in the Commonwealth Gazette.

  • The supply of a therapeutic good that is no longer entered on the ARTG is an offence which carries significant penalties.