September 28th – October 2nd 2026
Inform Items
- Updated guidance for reducing assessment fees for ARTG application audits and TGA conformity assessments of medical devices (including IVDs) – As planned, the revised fee reduction guidance for medical device assessments is now in place and available at Request a reduced medical device assessment fee | Therapeutic Goods Administration (TGA). Fee reductions remain discretionary and will continue to be considered case-by-case, meaning they are not guaranteed and eligibility should not be assumed. In line with previous correspondence, the key changes to the fee reduction guidance are as follows:
- Design examination fee reductions are now based on the number of component assessments (performance characteristics for IVDs) required for each Unique Product Identifier (UPI) within an application. This approach ensures that fees are more closely aligned with the effort and time required to complete the assessment while also improving predictability for sponsors.
- The reduced fee available for design examination and quality management system assessment recertifications (where there have been no changes since the previous assessment) has increased from 15% to 20% of the relevant schedule fee.
- Mandatory application audit fee reductions continue to be considered where devices are closely related and share the same technical documentation, with the full fee charged for the first device and a reduced fee for subsequent devices within the same application. However, the minimum fee payable for these subsequent devices has increased from 28% to 40% of the relevant schedule fee.
The new arrangements apply to applications received from 1 October 2026.
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TGA Business Plan 2026-27 – The TGA has published its Business Plan 2026-27 on its website. The plan sets out the TGA’s operational direction and priorities for the coming year. Guided by four Strategic Objectives, it identifies 17 focus areas aimed at improving public health outcomes, building trust, promoting compliance, and driving innovation and continuous improvement. It includes performance indicators to track progress and support transparent reporting. At the end of the reporting period, the TGA will publish a Performance Report on how it delivered against the focus areas and indicators. The plan also aligns the TGA’s work with the Australian Government’s performance reporting requirements, including Resource Management Guide 128. It sits alongside the Department of Health, Disability and Ageing’s broader planning and reporting documents, while giving a TGA-specific view of how regulatory work will be planned, delivered and reported.
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TGA Digital Transformation Program – The TGA has published new information on its Digital Transformation Program, including a dedicated page on upcoming changes to TGA Business Services. The update explains how TGA Business Services will move into the Health Business Services portal, what this means for users, and how industry can prepare ahead of the planned 2027 transition. A Beta demonstration is also planned for 2026. It will give users the chance to explore the new portal, see key features in action, and share feedback to help shape the user experience. Invitations to specific events will follow. Members are encouraged to read the update and share it with colleagues who may be affected. Questions and feedback can go to the Digital Transformation team at TGADigitalStakeholders@health.gov.au.
- New Advertising Guidance – Earlier this year, the TGA consulted on the draft ‘Determining when news is subject to the therapeutic goods advertising rules’ guidance. They have now published the new guidance – Determining when news is subject to the therapeutic goods advertising rules | Therapeutic Goods Administration (TGA). Information on advertising and compliance can be found on the TGA website: https://www.tga.gov.au/products/regulations-all-products/advertising/specialised-advertising-issues-and-topics
Action Items
- TGA Information Sharing Consultation – The TGA is consulting on proposed changes to how it shares information on the safety, quality and performance of medical devices, aligning with the Action Plan for Medical Devices and the requirements set out in WHO’s Global Benchmarking Framework. Proposed changes would give the public more information after post-market reviews or investigations, particularly on safety, quality, performance or use findings. Feedback is sought on whether and what type of information the TGA should share during such reviews. Open for MTAA member input on RegConnect till COB Wednesday 7 October 2026.
