Recent Updates from the TGA for member attention
International Updates
Strong engagement with European regulators on joint witness audits and mapping of audit procedures; possible future recognition clauses in MDR/IVDR, with a 2027 target for implementation.
MDSAP & UDI
TGA will maintain its own MDSAP webpage for Australia-specific nuances; upcoming training for auditing organisations will address UDI and AI topics.
Government Approvals
Australian manufacturers can use the MRA with the UK for certification and market access to the UK; and from 1 December 2025, formal recognition of UK approved bodies and certificates can be used to support ARTG inclusion applications.
AI Integration
Microsoft Copilot is being trialed for clinical information review, with challenges around handling sensitive commercial data, input format variability, and training. The enterprise version is not linked externally. The department has published an AI transparency statement, and future meetings may showcase specific use cases.
Discussion of regulatory pathways and initiatives to better support Medtech innovation
Dr Jeffrey Brownscombe (TGA) noted that innovation support is a frequent topic with stakeholders and aligns with broader government objectives for health outcomes, research, and domestic manufacturing. The TGA has commenced a review of the Priority Review pathway and sought preliminary feedback through a recent targeted industry feedback process, as well as exploring international models. Members noted the following insights from this project:
The priority review pathway offers front-of-queue processing for critical devices but is under-utilised compared to similar pathways in other countries. Dr Brownscombe reported that some stakeholders see the criteria as restrictive, especially for novel technologies, and there was mixed feedback on time savings and transparency. Some sponsors reported that the evidence bar is too high and statutory timelines are unclear. Stakeholder suggestions included clearer guidance, tailored evidence requirements, better collaboration with reimbursement bodies, and recognition of overseas regulator approvals. Criteria: Life-threatening/serious condition, unmet need, significant improvement, major clinical advantage, public health benefit. There have been only 1-2 determinations per year; most successful applications already have strong overseas evidence. Some stakeholders suggested relaxed criteria (e.g. broaden "life-threatening" to "significant condition"), allow for public interest tests, and improve internal handling. Dr Brownscombe noted that, subject to Government approval of any changes, relaxing the criteria could be low risk since the ARTG inclusion requirements would remain unchanged.
Procedure for Recalls, Product Alerts and Product Corrections (PRAC).
The TGA has published two new resources to compliment the Procedure for Recalls, Product Alerts and Product Corrections (PRAC).The news announcement is at New resources on market actions and minor PRAC updates | Therapeutic Goods Administration (TGA).
The two new resources are:A webpage featuring frequently asked questions (FAQs) on the PRAC, and
A guidance page on the use of legislative powers related to recalls and other market actions.
The new FAQ resource includes over 20 questions which the TGA receives frequently on the PRAC and market action requirements. This list of questions and answers will be updated as new enquiries emerge.
While the PRAC itself is not a legislative instrument, the new legislation guidance page is designed to help sponsors and suppliers of therapeutic goods understand the powers which the TGA can impose relating to market actions in Australia. This follows the legislative review which occurred as part of the final phase of the Recall Reforms Program, with the aim of ensuring our existing legislative provisions continue to support effective market actions under the new PRAC.
Additionally, as part of TGA’s continuous improvement initiatives, the PRAC has also been updated with minor changes, including:
amendment of the ‘Purpose’
updates to, and renaming the section titled ‘Situations requiring additional documents’ to ‘High profile actions or actions involving product which isn’t traceable’
minor wording changes to the definitions of ‘Recall’ and ‘Product Correction’ and
other minor editorial or small improvements.
Unique Device Identification (UDI)
The TGA reported on UDI and compliances readiness UDI database numbers, updates and ongoing support given we are only a couple of months off the UDI compliance date for Class lll and Class llb devices.
There are now 16,780 published records in the AusUDID, including 12,199 added in the first two months of 2026. Most current records relate to Class IIb (11,306; 67.4%) and Class III (2,500; 14.9%) medical devices, although records are also present for a range of other classes of medical devices and IVDs. While no records have yet been submitted through the machine-to-machine interfaces, interest in this submission pathway is increasing. With only four months remaining until the UDI compliance date for Class III and Class IIb devices, these numbers are expected to increase significantly in the coming months.
Ongoing updates
A set of updates to the AusUDID was released on 19 February 2026, introducing improvements to system usability, security and performance. At the same time, the Grace Period was extended, allowing sponsors and manufacturers up to 30 days to review and correct their UDI records before the UDI trigger rules apply.
Further system improvements are planned for implementation in May 2026.
The UDI Guidance documents and the UDI Hub also underwent substantial updates in February, with four new web pages added and seven existing pages updated. Most changes were made in response to questions and feedback received during and after the 2025 Roadshows, improving the clarity and readability of the guidance and enhancing navigation of the UDI Hub. Three additional guides covering the use of, and troubleshooting for, the AusUDID are planned for release in March.
UDI compliance
Work to embed UDI requirements into the TGA’s pre-market, post-market and auditing processes is well underway across the relevant TGA areas. This includes updates to MDSAP processes and documentation, as well as, where applicable, alignment with the activities of comparable overseas regulators.
Consultation on the proposed approach for a UDI Consent to Supply (CTS) closed on 30 January 2026, with 23 submissions received. The key issue raised in responses was the value of the proposed reduced fee for the UDI CTS, with near-equal support for Option 2 and Option 3. The TGA is finalising its review of submissions, with the aim of including the reduced fee in the 2026–27 Fees and Charges Regulatory Package, to take effect from 1 July 2026.
Changes to the Consent to Supply IT system to support a streamlined UDI application are well progressed and on track to be available for sponsor use in late March or early April. A guidance document and user guide to support sponsors in completing a UDI CTS application are currently being developed and are planned for release alongside the IT system.
Exempt medical devices will be the topic of a second consultation paper on their regulation.
Medical Device Single Audit Program (MDSAP)
The TGA convened its final meeting of the MDSAP Regulatory Authority Council (RAC) as Chair and Secretariat in December 2025 and formally transferred responsibility for these roles to the United States Food and Drug Administration (U.S. FDA) on 9 January 2026.
As part of this transition, the U.S. FDA, in its role as Secretariat, is coordinating next steps to finalise the application process for new MDSAP Auditing Organisations (AOs). Following completion of the assessment process, additional AO options are expected to become available to manufacturers in 2026.
In 2025, and in consultation with industry, the RAC agreed to establish a formal MDSAP Industry Group. The purpose of this group is to provide strategic and operational feedback.
Draft terms of reference have been provided to AdvaMed to coordinate broader industry review. It is anticipated that the group will hold its first meeting in 2026.
The TGA is also preparing an update to the MDSAP Audit Approach to incorporate Australian Unique Device Identification (UDI) requirements, with a clear delineation of manufacturer and sponsor responsibilities. The Medical Device Organisation (MDO) pilot, which commenced in August 2025, remains ongoing. While Australian regulatory requirements are outside the scope of the pilot, the TGA is closely monitoring its progress. In future, the TGA may consider audit report content from an MDO site, alongside the legal manufacturer audit report, to support applications and other regulatory activities.
The 2026 MDSAP Forum will be held in Kyoto, Japan, from 15-19 June 2026. Invitations to international industry bodies are to be issued. There will be no restrictions for remote attendance and open sessions will be live streamed on YouTube. Australian Manufacturer’s wishing to attend in-person will need to seek an invitation from their Auditing Organisation (AO) or from an industry association. Further information will be made available on the MDSAP Global website from March 2026.
Recognition of UK approved bodies as comparable overseas regulators
Since 1 December 2025, UK approved bodies are now recognised as comparable overseas regulators.
The TGA website and guidance materials have been updated to reflect these changes:
Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Amendment Determination 2025 - Federal Register of Legislation
Therapeutic Goods (Overseas Regulators) Amendment Determination 2025 - Federal Register of Legislation
Medical devices reforms: Mutual Recognition Agreements
Use of market authorisation evidence from comparable overseas regulators / assessment bodies for medical devices (including IVDs)
Adverse event reporting form and International Medical Device Regulators Forum (IMDRF) Adverse Event Reporting Codes
The TGA is currently reviewing the Medical Device Incident Reporting (MDIR) form for sponsors. In parallel, they are considering amendments to the Regulations to specify that adverse events must be submitted using a form approved by the Secretary. This proposed change would not alter the existing MDIR form or the current submission process via the MDIR system; rather, it would formalise the existing arrangements within the Regulations.
Separately, the TGA is assessing the feasibility of incorporating International Medical Device Regulators Forum (IMDRF) Adverse Event Reporting codes into sponsor reporting as part of post-market obligations. This approach would align Australia with other international jurisdictions, including the European Union, Japan, and the United States, and support the generation of harmonised and comparable post-market surveillance data.
Recent Government approvals and regulatory changes
Two legislative instruments have been made to clarify whether certain products are medical devices based on their principal intended action:
Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025
Therapeutic Goods (Medical Devices—Specified Articles) Amendment Instrument 2025
One legislative instrument has been made to allow approval of a specific kind of medical device as a substitute for medical devices that are unavailable:
| Information sharing | Consultation Intent | Dates |
| Information sharing | Consultation for proposed amendments relating to transparency of disruptions to supply of a medical device. | Opened 7 Jan 2026 Closed 20 Feb 2026 |
| Variations to ARTG entries | Consultation on refining the current framework, including fees, for varying ARTG entries | Q2 2026 |
| Boundary Products | Consultation on clarifying the regulatory categories of additional boundary products, and guidance | Q2 2026 |
| Information sharing | Consultation on proposals to refine TGA’s information sharing arrangements for post market reviews | Q2 2026 |
| Exempt Devices and Other Therapeutic Goods | A second consultation to refine the regulatory requirements for medical devices and other therapeutic goods that are exempt from certain premarket requirements including a model of notifications. | Q2/3 2026 |
| Patient-matched medical devices | Consultation on proposed refinements to the regulation of personalised medical devices, specifically for patient-matched medical devices including those manufactured at the point-of-care. We will also conduct a consumer survey seeking feedback from people who have experience with personalised devices. | Q2/3 2026 |
| Conformity Assessment Procedures | A second consultation on clarifying post-market requirements under conformity assessment procedures | Q2/3 2026 |
| Adverse event reporting forms | Targeted consultation to require adverse event reports submitted by medical device sponsors be provided in a specified form | Q2/3 2026 |
| Assistive Technologies | Consultation on refining the regulatory framework including any potential impacts on the NDIS and aged care programs | Q3 2026 |
| Digital mental health tools | Consultation on proposed amendments to the way we regulate digital mental health tools (DMHTs) including consideration of the current DMHT exclusion | Q3 2026 |
| Regulatory pathways for innovative medical devices | Consultation on options to improve the regulatory pathway for innovative medical devices, including the priority pathway | Q3 2026 |
| Adverse Event reporting requirements | Targeted consultation to require sponsors to provide IMDRF codes in their submissions | TBA |
| In-house IVD arrangements | Seeking feedback on the regulatory framework for in-house IVDs to verify whether it continues to be fit for purpose | TBA |
| Disinfectants | Conduct targeted and public consultation on the regulation of disinfectant products to refine the current arrangements and to align more closely with international risk classifications | TBA |
| Medical device vigilance program | Consultation on proposed options to implement an ongoing medical device vigilance program | TBA |
| Software and Artificial Intelligence | Conduct targeted and public consultations on proposed refinements to the current arrangements for the regulation of software and AI. | TBA |
| Clinical Trials | Consultation on legislative amendments to allow flexibility in administrative arrangements | TBA |
Amanda Trotman
CEO
ODMA
