Posted in TGA

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.

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.

The Therapeutic Goods Administration (TGA) has made further refinements to the regulation of personalised medical devices with the introduction of the Therapeutic Goods Legislation Amendment (2021 Measures No. 3) Regulations 2021.

The Amendment:

• Extends the deadline for stakeholders to register a patient-matched medical device for transition to inclusion in the Australian Register of Therapeutic Goods by 12 months to 25 August 2022.
• Introduces an exemption for patient-matched medical devices that are supplied in very low volumes, allowing the supply of up to five (5) devices each year without an inclusion in the ARTG.

The following web pages and guidance documents have been updated to reflect these refinements:

• The personalised medical devices landing page.
• Personalised medical devices (including 3D-printed devices).
• Custom-made medical devices landing page.

These refinements seek to address stakeholder concerns regarding their ability to meet their regulatory obligations and continue supplying personalised medical devices. 

Further consultation, both targeted and public, will be conducted by the TGA to identify additional refinements that could be made to ensure personalised medical devices are safe and fit for their intended purpose without imposing unnecessary administrative or regulatory burdens on businesses.

As you are aware the ADIA has worked closely with the Therapeutic Goods Administration (TGA) over the past 18 months on the development of the personalised medical devices framework.

On Monday the TGA announced a number of options for refining the framework that were identified as a result of the public consultations held over the last few months.

The ADIA advocated for a number of options to be considered in the development of the framework which included:

1. A review of Class 1 and Class IIa devices with a view to excluding very low risk products from Australian Register of Therapeutic Goods (ARTG) inclusion.
2. Continuing to include raw materials and components that are used to make medical  devices in the ARTG.
3. Maintaining a level playing field for all manufacturers of medical devices.
4. The ADIA suggested implementing a templated process to achieve a QMS system to reduce costs for the small laboratories and manufactures which was highlighted in a Risk Statement submitted by the ADIA in the initial consultation process.

In today's announcement the TGA have advised that: 

1. A limited number of low risk devices would be excluded from being considered to be medical devices.
2. Raw materials and components would stay on the ARTG.
3. The person assembling the low risk device would not need to include the device in the ARTG. 
4. The person assembling the device, including if they are a healthcare practitioner, will still need to meet all other regulatory requirements for medical devices.

An overview of these legislative instruments and their impact can be found on the TGA website.

What is required now?

If you manufacture or supply a product that has been included in the excluded goods determination, you do not need to register for transition or include the device in the ARTG.

If you have already registered a product that has been included in the excluded goods determination you are not required to take any further action.

Please Note:

If companies reacted to the TGA email re removing items from the ARTG before June 30 by deleting those entries, the ADIA will work with the TGA on the process for reinstating those entries.

Please reach out to the ADIA with a summary of how many ARTG entries were cancelled, and also advise on any applications rejected on the basis of the TGA position on raw materials, that will now need to be resubmitted