ADIA CEO Update: February Regulatory & Technical Update

Tags:

Posted on 12 February 2026

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?

The TGA operates on a cost recovery basis to fund the regulation of Therapeutic goods, including medical devices. Unlike last year, the TGA is proposing significant increases to the annual fees and charges in 2026-27.

The TGA is proposing two options - partial recovery and full recovery resulting in proposed increases of TGA fees by 4.3 or 4.8% respectively and annual charges by 4.0-4.2% or 6.1-6.3% respectively.

Please provide your feedback with specific examples of the hardship that higher fees and charges from full recovery would impose on your business. This will enable us to build the case to support the adoption of the lower fees and charges. You can respond directly to the TGA or send your feedback to us by 9am on Monday 23 Feb 2026.

Read the consultation paper

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.

Access the Amendment (Free)

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.

View the consultation paper

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.

By:ADIA