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.

There has been plenty of recent activity in the Advocacy Space. Last week during Dental Health Week, ADIA held its second Adelaide Dental Symposium and hosted a South Australian Dental Service key stakeholder, Ms Kristy Nixon. Kym De Britt, CEO provided a guided tour of the Exhibition, showcasing our members' innovative technology, that is facilitating dental treatment outside of traditional dental clinics, including mobile dental carts, scanners and 3D printers.

In other news, ADIA has been met with several other dental sector association leaders, including Nathan Clarke, the CEO of the newly-formed Oral Health Association of Australia (OHAA). OHAA has formed from the merger of Dental Hygienists Association of Australia (DHAA) and the Australian Dental and Oral Health Therapists Association (ADOHTA). In addition, ADIA participated in final workshop for the development of the next National Oral Health Plan which sets out the strategic focus for improvements in Australia’s oral health over the next decade.

ADIA has partnered with Colgate on two projects to raise the awareness of the Child Dental Benefits Schedule to eligible families. Firstly, including our ADIA CDBS Information brochures in Foodbank NSW School Breakfast Hampers (pictured) and also within G8 Early Learning Centres.

Our Director of Policy and Education, Dr Sarah Raphael and Technical Team member, Dr Joanne Challinor-Rogers participated in the Medical Technology Association of Australia, Regulatory Summit in July. To catch the regulatory information from the summit, which included global and TGA presenters, as well as news from the forthcoming TGA Regulatory and Technical Forum, join the Technical Forum at 1pm on Tuesday 2nd September. Register here

To get involved in ADIA Advocacy or share your thoughts and ideas, please contact Dr Sarah Raphael by emailingsarah.raphael@adia.org.au

STANDARDS AUSTRALIA CONSULTATION: DR AS/NZS 5369:2023 AMENDMENT

Standards Australia have a current consultation open until 22 September 2025 on amendments to:

DR AS/NZS 5369:2023 Reprocessing of reusable medical devices and other devices in health and non-health related facilities.

These amendments are centred on updates that result from the amendment of ISO 11139:2018/Amd 1:2024, 3.214.2 including impacts on sterilzation processes and process challenge devices.

To review the proposed amendment to the Standard, you are required register with Standards Australia. All comments are made online via the consultation portal.

Please follow these steps to provide your feedback.

Register and Log in

1. Visit Standards Australia
2. Hover on Committee Access - the blue heading on the top right of the menu bar.
3. Click on Public Comment where the list of open consultations will be listed.
4. Type "5369" in the Search Drafts bar.
5. If you are registered for Standards Australia - log on here. If you are not registered you can follow the prompts to register.

Providing feedback

Once you have registered and logged in:

1. Click on DR AS/NZS 5369:2023 Amd 1:2025.
2. Comments can be made throughout the sections of the document by either:

• Clicking the sections on the Table of Contents; or
• By using the Previous and Next buttons on the top right corner; or
• Comments can be made by clicking on the Add Comment button at the end of each section.
• Alternately, general comments can be made at the bottom of the "Draft Details" page.

Need help?

Additional help is available at the Help Guide to assist in navigating the Public Comment Portal.

If you require further information please email ADIA Director of Policy and Education, Dr Sarah Raphael