July 13th – 17th 2026
Inform Items
- Sydney Clinical Trials Centre – From 17 July 2026, the NHMRC Clinical Trials Centre has rebranded to the Sydney Clinical Trials Centre, reflecting its identity as the University of Sydney’s internationally recognised Clinical Trials Centre. Established in 1988 with NHMRC funding, the Centre remains a Flagship Centre within the University’s Faculty of Medicine and Health, with no change to sponsorship, governance, study delivery, or existing points of contact.
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TGA Fees and Charges – The Minister has determined updated TGA fees and charges, which took effect 1 July 2026, with the Cost Recovery Implementation Statement now published on the TGA website. Government approved Option 1 (full cost recovery of the TGA’s operating costs, in line with the Cost Recovery Framework), resulting in a 4.8% increase to all fees (3.3% indexation plus 1.5%) and a 6.1–6.3% increase to all annual charges (3.3% indexation plus up to 3%). The TGA advises these increases are necessary to fully recover known cost increases for 2026–27, maintain regulatory capacity and capability, and meet statutory obligations, while continuing to pursue efficiencies where possible.
Action Items
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TGA Advertising Code Consultation – The TGA has released a consultation on proposed changes to the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code), focused on clarifying unclear or inconsistent provisions and minor administrative updates, rather than the Code as a whole. Medical device stakeholders should note the proposed changes include advertising requirements and transparency measures for software-based medical devices, as well as other mandatory statements for medical devices. The consultation is open on RegConnect under the Consultations Hub, with member input due by COB 21 August 2026. Please share feedback via the platform, or use the Industry Comments section to discuss with peers ahead of the deadline.
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WHO MeDevIS Public Survey – The WHO Medical Devices and Assistive Technology team has launched a public survey on its Medical Device Information System (MeDevIS), inviting stakeholder input on the accessibility, quality, clarity, completeness, and usefulness of the platform’s data and content, as well as user experience and suggestions for improvement. The 35-question survey, developed with IHT Lab (University Campus Bio-Medico of Rome) and IFMBE, and in consultation with the WHO Strategic and Technical Advisory Group on Medical Devices, is anonymous and closes 31 August 2026. Members are encouraged to complete the survey here to help inform improvements to MeDevIS and support better access to medical devices globally.
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AI in Regulatory Practice Session – The MTAA RegConnect Summit 2026 (24 – 25 September) will feature a session exploring how AI is being used in regulatory and compliance work. If your organisation is applying AI in this space and you’d be interested in sharing your experience as part of the session, please reach out to Laila.
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Standards Australia Committee Seats, Call for Members – MTAA has 10 seats across the below Standards Australia technical committees currently open for MTAA member representatives:
- HE-003 – Medical Electrical Equipment
- HE-030 – Biological and Clinical Evaluation of Medical Devices
- SF-001 – Occupational Health & Safety Management
- HE-012 – Surgical Implants
- HE-032 – Biotechnology
- MS-024 – Optics and Ophthalmics
- TE-016 – Personal Alarm Systems
- MB-027 – Ageing Societies
- HE-023 – Processing of Medical and Surgical Instruments
We’re also seeking members to join a working group feeding into MTAA’s representation on Standards Australia’s ME-080 committee (Air Filters). This is not a direct seat on ME-080, but an internal MTAA group that reviews relevant draft standards and helps shape the positions MTAA puts forward. If you’d like to be involved in the group, or are interested in filling one of the above 10 seats, please reach out to Laila by COB Friday 24 July.
- Countdown Quiz Challenge & Profile Tags – Running 29 June – 31 July, the Countdown to RegConnect Challenge brings a daily multiple-choice regulatory question, with top leaderboard scorers winning tickets to RegConnect Summit 2026 🏆. While you’re on the platform, take a moment to update your RegConnect profile tags – log in and select your area(s) of expertise (e.g. RA, QA, Digital Health) under profile settings, so members can quickly identify who’s who across the community.
MTAA Events
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RegConnect Summit 2026 – MTAA’s RegConnect Summit 2026 program is shaping up to be incredible, with a strong lineup of international regulators confirmed to join us – bringing that IMDRF special flavour right to your backyard in Australia. And with so many of you already active on the RegConnect platform, it’s only fitting to take things one step further… time to reach the Summit! To make it easier to bring your team along, Early Bird pricing is now available for groups of 3 or more. Don’t miss the chance to lock in your seats and experience two days of world-class regulatory insight, right here at ICC Sydney, 24–25 September.
Thanks everyone, have a wonderful weekend!
