&geometry(706x85) "Australian Dental Industry Association")
Posted in Government & Regulation
ADIA CEO Update: August Regulatory & Technical Update
 "ADIA CEO Update: August Regulatory & Technical Update")
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.
Therapeutic Goods Administration (TGA)
The TGA's primary role is to ensure the safety, quality, and performance of therapeutic goods, including medical devices. This has been under the media spotlight in the past month. ADIA continues to foster a strong relationship with the TGA to facilitate an environment that balances patient safety with access to innovative health solutions, creating an environment where ADIA member businesses can thrive and continue to empower oral health professionals to advance the health and well-being of all Australians. Our next opportunity to engage with the TGA will be at the Regulatory and Technical Forum held in Canberra on 8 September 2026. If you have any issues to raise or require further clarification on TGA matters, please get in contact by Friday 28 August. |
The Top 3 Tech Updates for this month are:
MTAA RegConnect Summit 2026 - 24-25 SEPTEMBER in SYDNEY
Is Medical Device regulation part of your world?
Then the MTAA RegConnect Summit 2026 is a must for you!
The Summit is bringing together regulatory professionals, global health authorities, industry leaders and key stakeholders over the two day program, to explore the most pressing challenges and emerging opportunities in medical device regulation.
Therapeutic Goods Advertising Code
The TGA is currently consulting on Improvements to the Therapeutic Goods Advertising Code. This impacts:
- Advertising of Orthodontic Aligners
- Advertising requirements for Software-based Medical Devices
as well as proposed clarifications and amendments, mandatory statements and requirements for citations to research in advertising.
If you would like to have your views included in the ADIA submission, please send your comments and feedback to advocacy@adia.org.au by 25 August 2026.
Patient Matched Medical Devices (PMMDs)
The TGA are continuing consultations on the proposed regulatory reforms for PMMDs. ADIA attended an information session on 30 July to receive updates on the process. A Dental Sector specific session will be held in September and two public information webinars will follow.
We will continue to update you on this important issue in the coming months.
If you have information or issues you would like to raise, please contact us at advocacy@adia.org.au by 4 September 2026.
Questions & Feedback
We'd love to hear from you!
Contact Dr Sarah Raphael
Email: advocacy@adia.org.au
Phone: 0412 918 848
Please reach out to let us know what other Technical and Regulatory information you would find valuable in these monthly updates.
| Posted in:TGAIndustry NewsNews & MediaCEO UpdatesGovernment & Regulation |
ADIA CEO Update: Federal advocacy in action across Adelaide
 "ADIA CEO Update: Federal advocacy in action across Adelaide")
Federal Labor Business Exchange, Adelaide
Prime Minister Anthony Albanese delivering the keynote address at the Federal Labor Business Exchange lunch.
On 23 and 24 July, ADIA Director of Policy and Education, Dr Sarah Raphael represented the association at the Federal Labor Business Exchange in Adelaide, held alongside the 50th Australian Labor Party National Conference.
Across the two-day program, Sarah met with senior members of the Albanese Government, including:
- Minister Mark Butler - Health and Ageing, Disability and the NDIS
- Minister Sam Rae - Aged Care and Seniors
- Assistant Minister Rebecca White - Women, Indigenous Health and Health and Aged Care
- Assistant Minister Emma McBride - Mental Health and Suicide Prevention and Rural and Regional Health
- Minister Tanya Plibersek - Social Services
- Assistant Minister Ged Kearney - Social Services and the Prevention of Family Violence
- Minister Jess Walsh - Early Childhood Education and Youth
- Minister Anne Aly - International Development, Small Business and Multicultural Affairs
The meetings provided an important opportunity to discuss the dental industry’s priorities and strengthen relationships with ministers responsible for health, aged care, social services and small business, all which intersect with the dental industry.
Prime Minister Anthony Albanese delivered the keynote address at the Business Exchange lunch.
A Roadmap to Oral Health Reform
A significant outcome from the National Conference was the passage of an amendment to Labor’s policy platform committing the party to develop a roadmap to include dental services in Medicare. The roadmap would use a staged and evidence-based approach to improve access, prioritising people at the highest risk in the community. This represents an important policy development for oral health and provides a foundation for further engagement on how any future expansion could be designed and delivered.
 Meetings with senior members of the Albanese government. |  Prime Minister, Anthony Albanese delivering the keynote address. |
Senator Helen Polley Sees Bite Sized Beginnings in Action
The Bite Sized Beginnings Program Setup At Goodstart Early Learning Semaphore South.
Bite Sized Beginnings recently welcomed Senator Helen Polley to Goodstart Early Learning Semaphore South to see how the pilot is supporting children and families through practical oral health education and early intervention. |
Senator Polley has taken on the role of Co-Chair of the Parliamentary Friends of Dental and Oral Health alongside Dr Monique Ryan MP. During the visit, she saw firsthand how the program reaches families in a familiar and trusted early learning environment. |
She was particularly impressed by the program’s practical and accessible approach. By connecting with families in a setting they already know and trust, Bite Sized Beginnings helps make early oral health support easier to access. She is keen to stay informed as the pilot progresses and as opportunities are explored to expand the program nationally and reach more eligible children across Australia. |
Senator Helen Polley seeing Bite Sized Beginnings in action at Goodstart Early Learning Semaphore South on 23rd July 2026.
| Posted in:Industry NewsNews & MediaCEO UpdatesGovernment & RegulationAdvocacy |
ADIA CEO Update: ADIA Parliamentary Roundtable highlights the the value of early oral health prevention
 "ADIA CEO Update: ADIA Parliamentary Roundtable highlights the the value of early oral health prevention")
Last week ADIA returned to Australian Parliament House for its 2026 Parliamentary Roundtable. President Ryan Green together with ADIA Board directors and members met with parliamentarians and senior departmental representatives to discuss opportunities to improve oral health outcomes across Australia.
The Roundtable provided a direct forum for ADIA delegates to raise priority issues affecting the dental industry and the broader community. Discussions focused on improving awareness and uptake of the Child Dental Benefits Schedule, supporting better access to oral health care in aged care, and ensuring product regulation balances patient safety expectations with the ability to foster innovative product technology in Australia.
ADIA Parliamentary Roundtable delegates at Parliament House 2026
A key focus of the day was ADIA’s Bite Sized Beginnings pilot, which attracted strong interest from both parliamentarians and senior members of the Department of Health, Disability and Ageing. The program was recognised for its potential to support early childhood oral health education, reach families through early learning settings, and help identify oral health issues before they become serious. The discussions highlighted the value of case studies, stronger data and practical evidence to demonstrate how prevention can reduce avoidable hospitalisations and improve outcomes for children.
Senator Helen Polley sharing insights at Parliamentary Roundtable
The roundtable also marked an important advocacy milestone, with the Parliamentary Friends of Dental and Oral Health group reformed and co-chaired by Senator Helen Polley and Dr Monique Ryan MP.
ADIA welcomed this important opportunity to engage with Parliamentarians and Departmental staff and guests in a constructive day of discussion. The insights shared will help inform ADIA’s ongoing advocacy for a stronger dental industry and better oral health for all Australians.
If you would like to discuss any areas of ADIA’s Government advocacy, please get in touch with ADIA Director of Policy and Education, Dr Sarah Raphael at advocacy@adia.org.au
Senator Jordon Steele-John with ADIA Roundtable delegates
| Posted in:Industry NewsNews & MediaCEO UpdatesGovernment & RegulationAdvocacy |
2026-27 Federal Budget: Key measures for the dental industry
 "2026-27 Federal Budget: Key measures for the dental industry")
Key measures for the dental industry
The 2026-27 Australian Federal Budget includes a range of measures relevant to small businesses, dental suppliers, manufacturers, laboratories, practices and public oral health services. ADIA has prepared a detailed Budget Brief to help members understand the key announcements and what they may mean for the dental industry. For the dental sector specifically, the Budget confirms ongoing Commonwealth funding to support the delivery of dental care to eligible adult patients through state and territory public dental systems. In the past, this funding has only been provided as a short-term measure. The Budget also confirms ongoing access for State and Territory dental services to bill through the Child Dental Benefits Schedule. Public oral health services must continue to bulk bill eligible CDBS services through public-sector arrangements. This measure adds an addition source of Commonwealth funding for the State/Territory public oral health services. These are significant changes that allow the State/Territory public oral health services greater funding assurance for longer-term planning, staff recruitment and equipment procurement, which may support greater demand within the dental industry. The Budget confirms several broader small business measures, including the permanent $20,000 instant asset write-off, company loss carry-back arrangements, start-up loss refundability, R&D Tax Incentive changes, payroll and red-tape reform, and tariff simplification. These measures may support investment, cash flow, compliance and innovation across the dental supply chain. While the Budget does not include a dental-specific business package, several measures may have practical implications for ADIA members, particularly those involved in importing, manufacturing, technology development, public sector supply, clinical services and small business operations. ADIA’s Budget Brief outlines these measures, industry implications, and key watch points for members. Members are encouraged to seek professional advice where measures may affect tax planning, business structure, procurement, R&D activity or investment decisions. |
ADIA continues to advocate strongly with the Government, TGA and health stakeholders on members’ behalf. If you would like to get involved in our advocacy you can email us at advocacy@adia.org.au. |
| Posted in:Industry NewsGovernment & RegulationAdvocacy |
ADIA CEO Update: March Regulatory & Technical Update
 "ADIA CEO Update: March Regulatory & Technical Update")
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.
| Posted in:TGAIndustry NewsNews & MediaCEO UpdatesGovernment & Regulation |
