Australia’s medical-device critical supply disruption pathway has expanded

What changed in May 2026?

The TGA expanded the section 41HD approval pathway to include every classification of medical device and IVD. This creates a broader mechanism for responding when registered substitute devices are unavailable or in short supply and an alternative device is needed in the interests of public health.

The expansion does not create a general fast-track route for routine commercial supply. The pathway remains tied to a critical supply disruption and an application must address the relevant statutory tests and supporting evidence.

When may the pathway be relevant?

The TGA states that an approval may be considered where suitable kinds of devices already in the ARTG are unavailable, in short supply or foreseeably at risk of shortage; the proposed device has an appropriate overseas approval or has passed preliminary assessment for ARTG inclusion; and access is necessary in the interests of public health.

Sponsors should assemble evidence that explains the disruption, available substitutes, forecast demand, overseas regulatory status and the public-health need. The quality of this narrative and its supporting records is likely to be central to an efficient assessment.

Approval does not remove regulatory responsibilities

Devices supplied under section 41HD are not treated as included in the ARTG. The approval is subject to conditions that may address adverse-event reporting, supply records, changes in information, evidence of conformity, samples, English labelling and instructions, advertising, and continuing supply issues.

• Nominate clear responsibility for sponsor records and TGA communication.
• Confirm that English labelling and instructions meet the approval conditions.
• Maintain traceability for the source and destination of supplied devices.
• Integrate adverse-event and complaint handling into existing vigilance systems.
• Track the approval period and plan for expiry, extension or normal ARTG inclusion.

Planning beyond the immediate shortage

A shortage approval solves a time-limited access problem. Sponsors should also develop an exit plan: restoration of the usual device, transition to an ARTG-included alternative, or completion of a conventional inclusion pathway. Commercial forecasts and regulatory planning should be kept aligned so emergency supply does not become an unmanaged long-term position.