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Suspension & Cancellation

Overview​

An ARTG entry can be suspended or cancelled in two ways: by the TGA exercising its regulatory powers, or voluntarily by the sponsor. Understanding the distinction and the consequences of each is important for managing the device lifecycle and exiting the Australian market appropriately.

TGA-Initiated Suspension​

The TGA can suspend an ARTG entry when it has concerns about the safety, quality, or performance of a device but has not yet determined that cancellation is warranted. Suspension is a temporary measure pending investigation.

Grounds for TGA-initiated suspension include:

  • Post-market surveillance identifying a serious safety signal
  • Failure by the sponsor to comply with conditions of ARTG inclusion (e.g., non-payment of annual charges, failure to submit annual reports)
  • Failure of the manufacturer's conformity assessment evidence (e.g., certificate suspended by a notified body)
  • A serious adverse event or recall that raises questions about the device's ongoing acceptability

Effect of suspension: During suspension, the device may not be supplied in Australia. The TGA will typically notify the sponsor of the grounds for suspension and provide an opportunity to respond before suspension takes effect, unless an urgent safety issue requires immediate action.

TGA-Initiated Cancellation​

The TGA can cancel an ARTG entry where it determines that the device should no longer be on the Australian market. Grounds for cancellation include:

  • The device poses an unacceptable risk to patients or users
  • The sponsor has failed to comply with directions from the TGA
  • The sponsor has provided false or misleading information in the ARTG application
  • The conditions of inclusion have been persistently or seriously breached
  • Non-payment of annual charges after notice

TGA cancellation decisions are reviewable — sponsors can request reconsideration of a decision and may appeal to the Administrative Appeals Tribunal.

Voluntary Cancellation by the Sponsor​

A sponsor can voluntarily cancel their ARTG entry at any time by notifying the TGA. Reasons for voluntary cancellation include:

  • The device is being withdrawn from the Australian market (commercial decision)
  • The sponsor is no longer responsible for the device in Australia
  • The device has reached the end of its product lifecycle
  • The sponsor is consolidating multiple ARTG entries

Process for voluntary cancellation:

  1. Notify the TGA via the TBS portal of the intention to cancel
  2. Confirm there is no outstanding stock that needs to be managed before cancellation
  3. Ensure any ongoing post-market obligations (e.g., outstanding adverse event investigations, annual reports) are addressed before or at the time of cancellation
  4. The TGA processes the cancellation and removes the entry from the ARTG

Important: Cancellation does not relieve the sponsor of obligations that arose during the period of ARTG inclusion — adverse event reporting obligations, for example, continue for events that occurred while the device was on the ARTG, even after cancellation.

Obligations After Cancellation​

After an ARTG entry is cancelled (voluntarily or by the TGA):

  • The device cannot be legally supplied in Australia from the date of cancellation
  • Stock already with distributors or healthcare facilities may still be used, but the sponsor should consider whether a field safety action is needed for existing stock
  • Record-keeping obligations continue for the required retention period
  • Adverse event reporting obligations for events that occurred during the period of supply continue

Official Sources​