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TGA-Initiated Actions

Overview​

Most market actions are initiated by the sponsor or manufacturer when they identify a safety issue. However, the TGA has powers under the Therapeutic Goods Act 1989 to initiate recalls and other regulatory actions independently — particularly where a sponsor has failed to act, where an imminent risk to patient safety exists, or where post-market surveillance or adverse event analysis has identified a safety signal that the sponsor has not adequately addressed.

When the TGA May Initiate Action​

The TGA may initiate a market action where:

  • Post-market surveillance identifies a safety signal that the TGA believes warrants action, even if the sponsor has not initiated one
  • A sponsor fails to initiate a recall that the TGA determines is necessary
  • An overseas regulatory action affects devices supplied in Australia and the sponsor has not responded
  • The TGA identifies non-compliance with the Essential Principles or conditions of ARTG inclusion that poses a risk
  • Imminent public health risk exists and immediate action is required

TGA Regulatory Powers​

The TGA has a range of regulatory powers it can exercise in relation to ARTG-listed medical devices:

Mandatory recall direction Under Section 41GN of the Therapeutic Goods Act 1989, the TGA can direct a sponsor to recall a medical device if it is satisfied the device has caused or may cause harm or has an unacceptable risk of harm.

ARTG suspension The TGA can suspend an ARTG entry, preventing further supply of the device while a safety issue is investigated.

ARTG cancellation The TGA can cancel an ARTG entry, removing the device from the register and making further supply unlawful.

Safety alerts and public warnings The TGA publishes safety alerts and public warning notices on its website when it identifies safety issues with devices — even before or without a formal recall.

Infringement notices and civil penalties The TGA can issue infringement notices for breaches of advertising, labelling, or reporting obligations.

TGA Safety Alerts​

The TGA publishes safety alerts when it identifies safety signals from post-market surveillance or adverse event data. Safety alerts do not necessarily mean a device is being recalled — they may be precautionary notifications providing updated safety information to healthcare professionals.

Sponsors are notified when a safety alert relates to their device and must respond appropriately. In some cases, the TGA will direct a sponsor to issue an FSN even if no formal recall is required.

👉 TGA safety alerts — TGA

Cooperating With TGA-Initiated Actions​

When the TGA initiates or directs a market action, sponsors must cooperate fully and respond promptly. Failure to comply with a TGA direction is a serious offence under the Therapeutic Goods Act. Sponsors should:

  • Respond to TGA contacts within the timeframes specified
  • Provide requested documentation and information
  • Implement directed corrective actions on the timelines specified
  • Maintain records of all communications with the TGA

Official Sources​