ADIA CEO Update: March Regulatory & Technical Update

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Posted on 25 March 2026

Welcome to your monthly TGA and technical update. As your industry representative, your views shape the responses we make to consultations on everything from fees and charges to patient safety and sharing of your medical device data. If you have feedback on regulatory and technical matters, please get in contact at any time

What would the TGA Conformity Assessment Proposal mean for you?

This consultation has 8 proposals with wide-reaching impacts including the up-classifying of reusable surgical instruments and annual reporting for Class IIb and above medical devices. You can access the recording from the information session.

If your business has Class IIb medical devices registered with the TGA, including dental implants and abutments, autoclaves and washer/disinfectors, these proposals will impact you.

The deadline has been extended due to the complexity of the consultation and there is still time to respond. The consultation closes 31 March 2026. You can make your own submission via the link or send any comments you would like included in the ADIA submission by 20 March 2026.

Updates to the AusUDID

Improvements to the online portal and machine to machine HL7 SPL submission method are now live on the AusUDID portal. You can view the Release Notes for more information.

The AusUDID Grace Period in the AusUDID Production environment has been extended from 7 days to 30 days, allowing additional time to correct any errors from the early stages of the AusUDID data loading.

Guidance for Surgical Loan Kits has also been published.

Non-compliance on Annual Reporting can lead to ARTG cancellation

Annual reports for Class III and Class IIb devices for the first 3 years of inclusion on the ARTG are mandatory and are due on 1 October each year. The TGA is actioning compliance measures including ARTG cancellation for Sponsors who fail to submit on time.

You can find guidance on submitting annual reports here.

Product Recalls, Alerts and Corrections (PRAC)

New resources are now available, including FAQs, guidance on compliance, and minor changes to the PRAC, available here.

Adverse Event Terminology updated by IMDRF

Updated Adverse Event terminology, including revised terms, definitions and codes, has now been published on the IMDRF website.

Medical device supply disruptions from the Middle East

The TGA is monitoring disruptions or impacts to the supply of medical devices to Australia. If you are aware of disruptions or impacts from recent developments, please let the TGA know by emailing MD.SupplyDisruptions@health.gov.au.

We will continue to provide you with technical updates each month.

By:ADIA