ADIA CEO Update: TGA Updates

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.