Kylie Harris of Avant Dental receives ADIA Women in Dentistry Scholarship

The Australian Dental Industry Association (ADIA) is pleased to announce Kylie Harris of Avant Dental as the recipient of the 2026 ADIA Women in Dentistry Scholarship.

Founded in 2020, the Women in Dentistry program promotes the professional advancement of women in the oral health sector through networking, mentoring, and education. With a focus on career progression, ADIA established the Women in Dentistry Scholarship to support the development of women in the Australian dental industry. The scholarship aims to expand the recipient's professional education and governance skillset, ultimately benefiting the broader sector.

As the 2026 recipient, Ms Harris will be enrolled into the one-week residential Australian Graduate School of Management General Manager Course. “Thank you very much for the opportunity, I am truly honoured to have been selected as the recipient of the 2026 ADIA Women in Dentistry Scholarship. I’m looking forward to undertaking the AGSM General Manager Program and making the most of this opportunity, while sharing my reflections throughout the year.” Said Ms Harris.

This scholarship is one of several Women in Dentistry initiatives led by ADIA. Throughout the year, the association hosts free webinars designed to upskill women in the dental industry and support their advancement into senior executive and c-suite roles. "The Women in Dentistry program is all about fostering career progression and leadership opportunities for women in the dental industry. We're proud to support initiatives like the scholarship and webinar program which empowers talented professionals to grow their skills and contribute to the future of our sector." Said Kym De Britt, CEO of ADIA.

For more information about the Women in Dentistry program, webinars and future scholarship opportunities, visit adia.org.au/women-in-dentistry

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?

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.

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

Would increased TGA fees impact heavily on your business?

Important changes to AS/NZ 5369 - Small Steam Sterilisers

Standards Australia has released an Amendment for AS/NZS 5369:2023, which will primarily affect small steam sterilisers (with chambers < 60 L).

The main change is that references to "Bowie and Dick-type tests" have been replaced with Air Removal and Steam Penetration Tests (ARSPT). For small steam sterilisers (chamber < 60 L), the amendment requires that the manufacturer's instructions (user manual) are followed to determine what type of ISO 11140-6 compliant ARSPT (porous device or hollow device) should be performed daily.

For large sterilisers (chamber > 60 litres) a Bowie-Dick type test that conforms with ISO 11140-3, ISO 11140-4, or ISO 11140-5 must still be performed daily.

If you require further information, please contact us.

The Australian Ethical Health Alliance (AEHA)

The AEHA is a working group for SMEs who manufacture or supply pharmaceuticals or medical devices that focuses on ethical challenges to enter or stay in the market. If you would like more information or would be willing to participate in a roundtable to discuss the challenges you face with regard to ethics, please contact us by COB Friday 13 February.

Would you be happy to share your proprietary device information?

As part of a proposal to improve transparency in situations of medical device supply disruptions, the TGA has a proposal to release information to other parties, including alternative device sponsors in an effort to protect continuity of patient care.

Would you be happy to share your proprietary medical device information with your competitors? You can read the full consultation paper and respond directly to the TGA or send your feedback to us by 9am on Wednesday 18 Feb 2026.

TGA changes to conformity assessment procedures

TGA has proposed amendments to conformity assessment procedures for medical devices, as part of An Action Plan for Medical Devices and the ongoing Medical Device Reform program. You can access the recording from the information session.

The consultation closes 27 February 2026. You can make your own submission via the link or send any comments you would like included in the ADIA submission by 20 February 2026.

Digital Transformation of the TGA portal

You can still have your say about the TGA’s TBS business portal (Beta release). It’s not too late to visit the test site TGA website and provide feedback via a survey form until 28 February 2026.

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

Welcome back to what is shaping up to be a busy and important year for our industry. There is plenty ahead in 2026 to ensure that you, our valued members, can stay actively involved in your dental industry, while continuing to build on both your business and personal success.

In parallel, the ADIA Board and team remain focused on strengthening existing relationships and building new connections across the oral health sector. This work is fundamental to ensuring the dental industry moves sustainably into the future — creating a stronger environment not only for today’s businesses, but for the next generation to thrive and achieve their own goals.

With this in mind, I thought it timely to provide an update on ADIA’s recent engagement across the oral health sector and how this is supporting stronger advocacy outcomes for members.

Over recent months, ADIA has been meeting with senior executive and elected leaders from state-based Australian Dental Associations, including ADA Queensland, ADA Victoria and ADA Western Australia. While each discussion reflected local priorities, there were strong and consistent themes across all engagements.

Australian Oral Health Policy Institute (AOHPI)

ADIA continues to lead AOHPI. AOHPI is chaired by Dr Kathleen Matthews, with partners from The University of Sydney, The University of Melbourne, NSW Council for Social Service (NCOSS) and members who provide expertise in policy development. AOHPI aims to develop independent, authoritative and inclusive oral health policies that raise awareness and enact change for better oral health in Australia. Current areas of policy development include Aged Care, the Child Dental Benefits Schedule, Water Fluoridation and the Affordability of Dental Care in Australia. Visit aohpi.org.au.

National Oral Health Sector Forum (NOHSF)

Initiated by ADIA in 2024, NOHSF provides a facilitated platform for national oral health sector association representatives to meet, discuss common goals, maximise the impact of aligned advocacy initiatives and discuss shared pain points. Held alongside ADX exhibitions in Sydney, Melbourne and Brisbane, NOHSF has welcomed participation from key stakeholders including the Australian Dental Association (ADA), the Oral Health Association of Australia (OHAA), the Australian Dental Prosthetists’ Association (ADPA), the Dental Assistants’ Professional Association (DAPA) and the Royal Australasian College of Dental Surgeons (RACDS). The aim is, through collaborative efforts, to present a more united voice to key policy makers on the importance of oral health in overall health and wellbeing.

We will continue to keep members updated as these conversations progress. One of the best ways to stay informed is by attending our quarterly State Branch Briefings, which provide timely updates and an opportunity to ask questions and connect with fellow ADIA members. If you’re unable to attend, please feel free to get in touch with us via email at any time.

Wishing you a very successful year in 2026.

To ensure that you can stay up-to-date with the ongoing TGA Medical Device Reform program and any other regulatory information, we will be bringing you regular updates each month. If you have any feedback on regulatory and technical processes, changes or issues, please get in contact at any time.

UDI changes to Consent to Supply

The TGA is proposing a streamlined approach for sponsors unable to meet the UDI requirements including options for a reduced fee. Find out more and access the UDI Consent to Supply consultation. General UDI information and guidance can be found at the UDI Hub.

Submissions close:  23 January 2026.

You can make your own submission via the link or send any comments you would like included in the ADIA submission by 19 January 2026.

Public consultation on TGA Conformity assessment procedures

TGA is undertaking a public consultation on proposed amendments to conformity assessment procedures for medical devices, as part of An Action Plan for Medical Devices and the ongoing Medical Device Reform program.

The consultation closes 27 February 2026.

You can make your own submission via the link or send any comments you would like included in the ADIA submission by 20 February 2026.

Boundary and Combination Products

Toothpastes are among the Boundary and Combination products that have undergone recent regulatory changes based on their principal intended action starting on 1 January 2026.

From this date new ARTG inclusions must be entered under the correct regulatory pathway at the time of inclusion. Existing ARTG entries will have a five year transition period until 31 December 2030.

Find out more here.

TGA Regulatory engagement meetings

Did you know that you can access these meetings to discuss the regulatory requirements for your medical device?

Meetings can be accessed from the start of  medical device development all the way to seeking inclusion in the ARTG. They can help to navigate the regulatory requirements and pathways, understand the supporting information needed for an application and identify any issues before applying. TGA are keen to engage early to ensure a more seamless path to approval.

For more information, visit the TGA here.

Digital Transformation of the TGA portal - Beta release

You can access videos of the new system, featuring a refreshed TBS portal, GMP clearance form and Case Management Solution on the TGA website.

You can provide feedback via a survey form until 28 February 2026.

Save the date for the next ADIA Technical forum

Tuesday 31 March 2026
1-2pm

• Join Dr Joanne Challinor-Rogers, Ms Clare Martin and Dr Sarah Raphael for the latest TGA Updates following the first 2026 Reg Tech Meeting in Canberra.
• Email any technical questions ahead of time to have them addressed during the forum
• Any questions, email advocacy@adia.org.au or phone Dr Sarah Raphael on 0412 918 8484

We look forward to sharing more news on all the important ADIA projects, advocacy and events throughout the year.