TGA Update Bulletin November 2025
Having attended a RegTech meeting last Friday and receiving various TGA update emails this last month or so, I wanted to provide a summary of the main information here for ODMA Members.
Should you at any time want to see minutes of past RegTech meetings or contribute agenda items to upcoming meetings, I can always assist with that.
Regards
Amanda Trotman
CEO
ODMA
This Week’s Meeting Notes - Key Points for Optical
Software in medical devices
Industry made the point that software may be required to have updates or corrections however clear directions are needed for when matters need attention, for instance product alerts, given the need for quick TGA responses so there are no patient impacts.
Manufacturers evidence online form
Deemed currently not fit for purpose. TGA has put some workarounds in place to assist with uploading multiple attachments and additional supporting documentation through the quick pick. Note that when you are asked for an expiry date that you need to use the extension letter expiry date. Some of these steps and items were noted to be unique to Australia and are frustrating manufacturers and are being reviewed.
Ministers have stated they seek health related bodies to undertake joint advocacy to Government.
Conformity deadlines will be incorporated into TGA KPIs.
Accord noted they are still having trouble launching devices into Australia and that they are seeking closer alignment with international standards for items such as sunscreen despite Australia’s UV levels. (ODMA through its Standards representatives will be involved in a similar discussion no doubt in relation to sunglasses).
Cosmetic Contact Lenses
There was a call to ODMA to provide input to an upcoming virtual roundtable on cosmetic contact lenses. ODMA informed contact lens related members and then referred this to Standards reps for involvement given no member offers purely cosmetic contact lenses, only prescription lenses with tints. ODMA did highlight to the committee that there are some lenses that enhance the appearance of the eye (limbal ring contact lens designed to give the illusion of a larger iris) and there is also the matter of unregulated lenses that remain a health hazard such as Halloween lenses and these matters will all be discussed. The roundtable will be seeking stakeholder feedback on a range of issues, including consumer safety concerns, potential regulatory approaches, enforcement challenges, and market impacts.
Recent TGA Updates
Unique Device Identification (UDI)
As of 14 October 2025, the Australian Unique Device Identification Database (AusUDID) contains 1,682 published records linked to at least one ARTG inclusion. An additional 895 records are present but not yet publicly linked. The recent UDI Roadshows have significantly contributed to this growth, with 927 new records added between 1–14 October, well above the monthly average of 263 records since July.
Upcoming AusUDID Updates
Pre-Production environment: 29 October 2025
Production environment: 3 November 2025
These updates will include:
Usability enhancements to the bulk upload Excel template (v2.9), including filter functionality
Portal improvements to distinguish between Pre-Production and Production environments
New search capabilities for manufacturer name or TBS ID
Accessibility upgrades, including screen reader compatibility
The next major release is planned for late December 2025 or early January 2026.
Sponsor Engagement
The Sydney and Melbourne UDI Roadshows attracted 400 sponsors, with overwhelmingly positive feedback on format and content. The TGA thanks RegTech members for their support.
Key follow-ups include:
Roadshow slides emailed to attendees (15 October) and published on the UDI Hub in early November
A summary of questions and discussion points to be shared via email and the UDI Hub
Progressive updates to documentation and new artefacts for sponsors
International Medical Device Regulators Forum (IMDRF) - Adverse Event Reporting Codes
The TGA has commenced a review of the current process for applying IMDRF codes in the triage and risk assessment of adverse event reports. In parallel, we are exploring the feasibility of integrating coding into sponsor reporting as part of post-market obligations. This approach would align Australia with other international jurisdictions - including the EU, Japan, and the USA - and support the generation of harmonised, comparable post-market surveillance data.
This work is in its early stages, and further advice will be provided to RegTech members on opportunities to participate in future consultations.
Clarifying consent to supply (CTS) processes on the TGA website, and links with the procedure for recalls, product alerts and product corrections (PRAC)
In response to feedback from industry stakeholders, the TGA is updating its webpages to better clarify the relationship between Consent to Supply (CTS) and Procedure for Recalls, Product Alerts and Product Corrections (PRAC) actions.
The revised content will offer clearer guidance on selecting the most appropriate pathway, supported by illustrative examples. It will include information on:
a case-by-case approach for PRAC actions and CTS requirements,
considerations based on the type of device, its clinical use, criticality in healthcare, the nature of the issue, and any associated safety concerns.
The Medical Technology Association of Australia (MTAA) has provided valuable examples to inform this update. TGA are prioritising this work, with updated webpages expected to be published before the end of 2025.
Recent TGA Updates
IMDRF Consultation – Essential Principles and Content of PCCPs
The International Medical Device Regulators Forum (IMDRF) Software as a Medical Device (SaMD) Working Group has published the draft Essential Principles and Content of Predetermined Change Control Plans (PCCPs) document for public consultation.
This document is intended to support the development of PCCP frameworks that may allow regulatory oversight to keep step with the rapid pace of software development practices. The framework is broad but harmonised and is intended to allow jurisdictions to tailor the proposed concepts to suit their unique regulatory environments.
Submissions close 8 December 2025.
Provide your feedback here: IMDRF home - Medical devices - Citizen Space
UK recognition as a comparable overseas regulator
The Therapeutic Goods (Overseas Regulators) Amendment Determination 2025 and Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment Determination 2025 have been signed and included in the Federal Register of Legislative Instruments.
These instruments recognise the UK approved bodies (UKCA bodies’) under our comparable overseas regulator arrangements and the related preliminary assessment requirements. They will commence from 1 December 225 and be incorporated into the consolidated instruments after that date.
By 1 December 2025 we will also update:
TBS code tables to allow inclusion of UKCA certification as manufacturer’s evidence and use to support ARTG inclusion applications.
COR web content, preliminary assessment guidance and Brexit web content
Government approvals and regulatory changes
Amendments to the Therapeutic Goods (Medical Devices) Regulations 2002 have extended the transitional arrangement for in-vitro diagnostic (IVD) companion diagnostics until 31 December 2028. These changes have taken effect from 1 October 2025, aligning Australia’s timelines with the European Union’s extended transition period for class 3 IVD medical devices.
The Health Legislation Amendment (Improved Medicare Integrity and Other Measures) Act 2025 received royal assent on 4 September 2025. Upon enactment, it amended several Acts in the Health, Disability and Ageing portfolio to implement a range of public health reforms. Of particular relevance to medical devices, the Therapeutic Goods Act 1989 was amended to address:
Vaping measures
Enforceable directions
Delegation powers
Therapeutic goods shortages
Review of decisions
Consent to supply
Information release provisions
These amendments are part of broader efforts to strengthen regulatory oversight and align Australia’s framework with international standards. The originating bill and explanatory memorandum are available here.
Recent guidance changes
Guidance for sponsors of medical devices seeking to include a medical device (including in vitro diagnostic devices) in the Australian Register of Therapeutic Goods (ARTG).
This guidance is for sponsors of applications for inclusion of medical devices, including IVD devices, in the ARTG.
Understanding selection criteria for medical device application audits | Therapeutic Goods Administration (TGA).
Understanding the medical device application audit process | Therapeutic Goods Administration (TGA).
TGA Bulletin on Website Updates
Our website has been through some recent changes that will make finding information easier. These improvements are based on your feedback and extensive user testing.
Enhanced primary navigation
You spoke and we listened. Users told us they had trouble finding information. We’ve improved the structure, by grouping more ‘like’ information together.
Safety and shortages: Your go-to for reporting problems or finding information about safety, recalls, and shortages.
Product regulation: Here you’ll find regulatory content, organised by product type, just for industry.
Resources and guidance: Information for consumers and health professionals, as well as regulatory guidance for industry.
Business Services: Quick access to TBS, where you can manage applications and ARTG entries.
Home: A new homepage link makes it easy to return to the main page from anywhere on the site.
New or updated pages
Understanding selection criteria for medical device application audits | Therapeutic Goods Administration (TGA) (refer to above)
Understanding the medical device application audit process | Therapeutic Goods Administration (TGA) (refer to above)
Other enhancements include updates to the global navigation in the top right corner. Here, you can access TGA ‘News and events’, contact details, and corporate information.
Mega menus
We’ve made it easier to navigate the new sections by introducing a mega menu for each primary navigation item. Now you can browse popular content in a single view.
What’s new
To stay up-to-date, users had to check several different pages every day. Now, with What’s New, all recent changes to the website are conveniently collected on a single page.
Some content has been moved during these updates. Links will redirect you automatically, but please update your bookmarks. If you run into any issues, please report them.
Workplan including upcoming consultations
| Consultation Topic | Consultation Intent | Dates |
| Conformity Assessment Procedures | Review the Australian Conformity Assessment Procedures including, where appropriate, alignment with the EU. | Q4 2025 |
| Patient-matched medical devices (PMMD) | Proposed refinements to the current arrangements for the regulation of patient-matched medical devices, including those manufactured at the point-of-care. | Q4 2025 |
| Boundary Products | Consultation on clarifying the regulatory categories of additional boundary products and guidance. | Q1 2026 |
| Variations to ARTG entries | Consultation on refining the current framework, including fees, for varying ARTG entries. | TBA |
| Assistive Technologies | Consultation on refining the regulatory framework. | Q1 2026 |
| Exempt Devices and OTGs | Consultation #2 on proposed regulatory changes for exempt medical devices and OTGs. | TBA |
| In-house IVDs | Review of In-House IVD arrangements. | TBA |
| Disinfectants | Review and refine the current framework for therapeutic disinfectant goods and align more closely with international risk classifications. | TBA |
| Adverse event exemption rules | Follow-up consultation on implementation options. | TBA |
| Medical device vigilance program | Consultation on next steps, including broader implementation following the pilot program. | TBA |
| Clinical trials | Pending review of additional requirements implemented in 2024, proposed refinements to the current arrangements for clinical trial requirements. | TBA |
| Software and Artificial Intelligence (AI) | Proposed refinements to the current arrangements for the regulation of software and AI. | TBA |
