TGA Expands Recognition of UK Approved Bodies for Medical Devices and IVDs
The Australian Therapeutic Goods Administration (TGA) has updated its guidance on the use of market authorisation evidence from comparable overseas regulators and assessment bodies, now formally recognising UK Approved Bodies within its framework for medical devices and in vitro diagnostic medical devices (IVDs).
The guidance, originally published in 2018, was updated on 11 May 2026 and reflects the TGA’s ongoing strategy to leverage international regulatory reliance pathways.
What Has Changed?
The key update is the inclusion of UK Approved Bodies as comparable overseas regulators. This means that evidence generated through UK conformity assessment procedures may now support:
Applications for inclusion in the Australian Register of Therapeutic Goods (ARTG)
Possible abridged assessments for TGA Conformity Assessment certificates
This is particularly relevant for manufacturers already operating under the UK regulatory framework and pursuing UKCA marking.
Why This Matters for Manufacturers
For manufacturers, this update could help streamline access to the Australian market by allowing greater use of existing regulatory evidence.
Potential benefits include:
Reduced duplication of conformity assessment activities
More efficient use of existing technical documentation
Faster market access strategies for Australia
Improved alignment between UK and Australian regulatory pathways
Manufacturers with established UKCA certification strategies may now be able to leverage existing approvals more effectively when preparing submissions to the TGA.
Continued Trend Toward Regulatory Reliance
The update also reflects a broader global trend toward regulatory reliance and international harmonisation. In recent years, the TGA has progressively expanded the list of recognised comparable overseas regulators, including previous additions such as Singapore’s HSA and updates related to EU MDR and IVDR transition timelines.
For manufacturers managing multi-market regulatory strategies, these developments may help reduce administrative burden and support more coordinated global submissions.
Important Considerations
Manufacturers should note that recognition of overseas evidence does not automatically guarantee ARTG inclusion or exemption from Australian requirements. The TGA may still request additional documentation or conduct further assessment depending on the device classification and submission pathway.
Companies should also carefully review:
Device classification alignment
Scope of certificates
Applicable transition provisions
Post-market obligations in Australia
Read the full document below.
