Australian TGA Expands Capabilities to Address Potential Medical Device Supply Disruptions

By Evan Ruby

Background

Health authorities worldwide have recently communicated measures to monitor and mitigate risks of medical device supply disruptions or shortages arising from the ongoing conflict in the Middle East. As Emergo experts previously reported, the Australian Therapeutic Goods Administration (TGA) announced that it is monitoring potential impacts to the supply of medical devices and IVDs and has initiated targeted outreach for products known to be manufactured in or supplied through the affected region. 

More recently, the TGA has introduced regulatory amendments to strengthen its ability to respond to potential shortages and support continued access to medical devices and IVDs.

The Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026

In March, the TGA issued the Therapeutic Goods (Medical Devices—Foreign Countries) Determination 2026 to enable the approval of certain “specified medical devices” that are not included in the Australian Register of Therapeutic Goods (ARTG) based on Section 41HD of the Therapeutic Goods Act 1989. Under the Determination, approvals may be granted where specific conditions are met, including that:

• Medical devices of the same kind included in the ARTG are, or may become, unavailable or in short supply, and their authorization is necessary in the interests of public health.
• The device to be supplied is registered or approved in at least one country listed in Schedule 1 of the Determination or is the subject of an ARTG inclusion application submitted to the TGA.
• The device type is specified in Schedule 2 of the Determination.

At commencement, Schedule 2 was narrowly scoped, only identifying “cannulas for use in cardiac surgery or cardiopulmonary bypass procedures.”

Expansion of Eligible Medical Devices and IVDs

In April, the Therapeutic Goods (Medical Devices—Foreign Countries) Amendment Determination 2026 was issued to amend the Determination by significantly expanding the range of devices specified in Schedule 2. As amended, Schedule 2 now includes all medical devices and IVD risk classes. 

Accordingly, as of May 1, 2026, the TGA may exceptionally authorize medical devices and IVDs if they are authorized for marketing in the European Union, Brazil, Canada, China, Japan, Singapore, the United States or the United Kingdom. The TGA publishes additional details, including devices approved for supply under the Determination, on its website.

Concluding remarks

These amendments materially expand the TGA’s regulatory flexibility to respond to actual or anticipated shortages of critical medical devices and IVDs, whether driven by the ongoing conflict in the Middle East or by other circumstances, and they reflect the TGA’s proactive and reliance-driven approach to market authorization. 

As the current geopolitical crisis and other external factors continue to challenge medical device availability around the world, manufacturers and other stakeholders should remain attentive to evolving regulatory pathways designed to preserve patient access.