TGA Now Accepting UK Conformity Assessed (UKCA) Certification as Comparable Overseas Evidence: What This Means for Medical Device Sponsors

The Australian Therapeutic Goods Administration (TGA) has updated its comparable overseas regulatory framework to formally recognise UKCA certification from UK Approved Bodies as acceptable overseas evidence for medical device applications. The updated guidance came into effect on 11 May 2026 and follows on from the acceptance of such evidence under the Australia and UK Mutual Recognition Agreement.  This marks an important development for medical device manufacturers and Australian sponsors seeking more flexible and efficient pathways to market.

What Has Changed?

Under the updated framework, the TGA now accepts UKCA certification issued by recognised UK Approved Bodies as comparable overseas evidence for:

• Applications for inclusion in the Australian Register of Therapeutic Goods (ARTG)
• Certain abridged TGA conformity assessment applications
• Medical devices and IVDs above Class I

Previously, UKCA certification was not recognised under the TGA’s comparable overseas regulator arrangements following Brexit.

The change aligns the UK more closely with other recognised overseas regulatory systems already accepted by the TGA, including the EU, FDA, Health Canada, and MDSAP pathways.

Why This Matters for Sponsors and Manufacturers

For manufacturers already holding UKCA certification, this update may significantly simplify Australian market access.

Potential benefits include:

Reduced Regulatory Duplication

Manufacturers may now be able to leverage existing UKCA evidence rather than undergoing a full conformity assessment for Australia.

Faster ARTG Pathways

By relying on comparable overseas evidence, sponsors may benefit from streamlined assessment pathways and reduced TGA review requirements where appropriate.

Greater Flexibility Post-Brexit

Since Brexit created separation between EU CE marking and UKCA certification systems, many manufacturers have faced additional regulatory complexity. Recognition of UKCA evidence by the TGA helps restore an additional pathway for global market access strategies.

Expanded Market Opportunities

Manufacturers focused primarily on the UK market may now find Australia a more commercially accessible jurisdiction without requiring duplicate regulatory certifications.

What Sponsors Should Consider

While the TGA now accepts UKCA evidence, sponsors should still ensure:

• The UK Approved Body and certification fall within the scope accepted by the TGA
• Technical documentation aligns with Australian requirements
• Evidence is complete and appropriately mapped to ARTG application requirements
• Device classifications and intended purpose are consistent across jurisdictions

The TGA’s updated guidance also outlines specific documentation requirements and circumstances where abridged assessments may apply.

How We Can Help

Navigating evolving global regulatory frameworks can be complex, particularly where UKCA, CE, and TGA requirements intersect.

Our team can assist with:

• Assessing eligibility for the new UKCA pathway
• Preparing ARTG inclusion applications
• Gap assessments between UKCA and Australian requirements
• Regulatory strategy for multi-market device submissions
• Sponsor support and ongoing compliance obligations

As international regulatory harmonisation continues to evolve, this update presents a valuable opportunity for manufacturers seeking a more efficient route into the Australian market.

For further information about how these changes may impact your devices or applications, please contact our team.