Understanding Australia’s Consent to Supply Mechanism for Medical Devices
Over the past several years, Australia’s medical device regulatory framework has undergone significant change. From the transition to the European Medical Device Regulation (EU MDR) to the implementation of Australia’s Unique Device Identification (UDI) system, manufacturers and sponsors have had to navigate a range of new regulatory requirements.
These reforms have also brought renewed attention to one of Australia’s lesser-known regulatory mechanisms, the Consent to Supply (CTS) framework.
While the CTS provisions have existed within Australia’s therapeutic goods legislation for many years, many regulatory professionals are unfamiliar with how the mechanism operates, when it may be available and, importantly, when it does not apply.
These questions were the focus of two interactive Solution Circle discussions facilitated by KD&A Managing Director Kea Dent at the Euro Convergence RAPS conference in Lisbon, Portugal, in May 2026. The sessions brought together regulatory professionals from around the world to discuss practical scenarios involving Australia’s CTS framework, highlighting growing international interest in Australia’s regulatory landscape and the common misconceptions surrounding CTS.
Kea at RAPS Euro Convergence 2026
This article explains what CTS is, when it may apply, and why recent regulatory reforms have brought renewed attention to this important – but often misunderstood – legislative mechanism.
What is CTS?
CTS is a legislative mechanism under the Therapeutic Goods legislation that enables the Therapeutic Goods Administration (TGA) to permit the continued importation, exportation or supply of therapeutic goods in specific circumstances where they may not fully comply with certain legislative requirements.
Importantly, CTS is not an alternative approval pathway and does not replace the requirement to comply with Australian regulatory requirements or maintain inclusion of a medical device in the Australian Register of Therapeutic Goods (ARTG), where applicable.
Rather, it is a discretionary mechanism that the TGA may use in limited circumstances where continued supply is considered appropriate and in the interests of public health. Each application is assessed on its own merits, considering factors such as patient access, the potential impact of supply disruption and whether the legislative criteria have been satisfied.
Why has CTS received increased attention?
The purpose of CTS has not changed. However, recent regulatory reforms, including the EU MDR transition and Australia’s staged rollout of UDI requirements, have prompted greater discussion about when it may be available.
These reforms have increased awareness of the mechanism, particularly where transition arrangements may affect the continued supply of medical devices.
It is important to remember, however, that CTS is not a routine regulatory strategy or an automatic extension of compliance deadlines. It is a discretionary legislative mechanism that may be available only in specific circumstances where the TGA considers continued supply to be appropriate.
A practical example: Transitioning to the EU MDR
The TGA has published several practical examples demonstrating how CTS may apply during regulatory transitions.
One example considers a manufacturer transitioning a shoulder implant from the MDD to the MDR. During the transition, the manufacturer determines that the Instructions for Use (IFU) should be updated to clarify that the implant is suitable only for adults, rather than both adults and children.
Whether CTS is required depends on the reason for the change.
If the manufacturer no longer holds sufficient clinical evidence to support use in children, continuing to supply devices with the original IFU would mean the device no longer complies with the Australian Essential Principles. In this circumstance, CTS would be required before those devices could continue to be supplied in Australia.
Conversely, if appropriate clinical evidence continues to support use in both adults and children, or if the remaining stock is relabelled or accompanied by updated IFUs before supply, CTS may not be required.
This example highlights an important distinction: CTS is not required simply because labelling or documentation changes. Rather, it becomes relevant where those changes mean the device no longer complies with Australian regulatory requirements.
Recent example: Australia’s UDI transition
Australia’s implementation of the UDI framework provides a recent example of how CTS may be used during a significant regulatory reform.
From 1 July 2026, mandatory UDI requirements apply to Class III and Class IIb medical devices. Recognising that some sponsors may require additional time to complete implementation activities, the TGA has introduced a specific CTS pathway for eligible sponsors affected by the UDI transition.
This pathway supports the orderly implementation of the new requirements while minimising unnecessary disruption to supply.
However, it does not change the underlying compliance obligations. Sponsors remain responsible for meeting the applicable UDI requirements within the timeframe approved by the TGA, and the existence of this pathway should not be interpreted as indicating that CTS will be available for every regulatory transition.
Practical considerations
Where a CTS pathway may be available, organisations should consider:
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- Does my product meet the eligibility criteria?
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- What evidence will the TGA require?
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- What activities must be completed before the consent expires?
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- What happens if compliance cannot be achieved within the approved timeframe?
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- What contingency plans are available if CTS is not granted?
Early planning remains the best approach to managing regulatory change. CTS does not alter ongoing obligations relating to post-market surveillance, complaint handling, incident reporting or ensuring the continued safety and performance of medical devices.
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- CTS is a discretionary legislative mechanism, not an alternative approval pathway.
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- It should not be relied upon as part of routine regulatory planning or viewed as an automatic extension of regulatory deadlines.
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- Recent reforms have increased awareness of CTS, but they have not changed its purpose.
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- Whether CTS is required depends on the nature of the regulatory issue, not simply because labelling, documentation or regulatory requirements have changed.
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- Early planning remains the best strategy for achieving compliance and minimising unnecessary supply disruptions.
As Australia’s medical device regulatory framework continues to evolve, understanding the purpose – and limitations – of the CTS mechanism can help manufacturers and sponsors better navigate regulatory transitions while keeping compliance as the primary objective.
