TGA Consultation on Improved Sharing of Information about Medical Devices: Proposed Legislative Amendments to Publish Safety, Quality or Performance Concerns
On 13 August 2026, the Therapeutic Goods Administration (TGA) opened a public consultation on proposed legislative amendments that would allow it to publish more information about medical devices following post-market reviews or investigations. The proposal focuses on information relating to device safety, quality, performance and use, including circumstances where reviews conclude without regulatory action.
Overview
Authority | Therapeutic Goods Administration (TGA) |
Date | 13 August 2026 |
Focus | Publication of information arising from medical device post-market reviews and investigations |
Type | Public consultation on proposed legislative amendments |
Deadline for comments | 2 October 2026 |
What is this about?
The TGA is considering legislative amendments that would expand its ability to publicly disclose information obtained through medical device post-market reviews and investigations. Under the current framework, disclosure is generally limited to specific circumstances, such as where a regulatory decision has been made or publication is necessary to support the safe use of a device.
The proposal would permit broader publication of information relating to the reasons for reviews, their findings and outcomes, including cases where devices are found to be compliant and no regulatory action is required. According to the TGA, greater transparency could foster trust in the regulatory system and reduce the need for stakeholders to seek such information individually.
Consultation details
The consultation seeks feedback on:
Whether information about medical devices subject to post-market review or investigation should be shared with the public
What information would be appropriate to publish
Any additional views on the proposed approach
Information under consideration may include:
Identification details of the device concerned (e.g., name, model, ARTG entry, sponsor and manufacturer)
Reasons for a review or investigation
Relevant manufacturing or device information
High-level findings and outcomes
Reasons for regulatory action, where applicable
Findings where no regulatory action was required
The TGA states that it does not intend to publish commercially sensitive information, such as detailed material formulations or target analytes.
Key timeline
Consultation opened: 13 August 2026
Deadline for comments: 2 October 2026
Why this matters
The proposal could increase the amount of information made publicly available about medical devices undergoing regulatory review in Australia, including reviews that do not result in regulatory action. As a result, manufacturers, sponsors and other stakeholders may face greater visibility of review findings and outcomes.
The consultation also raises questions regarding the balance between regulatory transparency and the protection of commercially sensitive information.
Who should consider responding?
Medical device and IVD manufacturers
Australian sponsors
Industry associations and regulatory professionals
Healthcare professionals and healthcare organisations
Consumer and patient organisations
Researchers and other medical device experts
Practical implications
Stakeholders may wish to:
Review the categories of information the TGA proposes to publish
Assess potential confidentiality, commercial and operational impacts
Consider whether sufficient context should accompany published findings, particularly where no regulatory action is taken
Identify any additional information that could improve transparency for patients and healthcare professionals
Submit practical examples or recommendations regarding appropriate safeguards and disclosure practices
Support with stakeholder responses
We support organizations in:
Assessing whether regulatory consultations are relevant to their products, technologies, or business objectives
Identifying strategic risks, opportunities, and emerging regulatory trends
Preparing structured and evidence-based responses to authorities
Contact us if you would like to discuss how this request may affect your organization, software portfolio, or planned regulatory activities.
Note
Check back regularly for updates on ongoing consultations and emerging regulatory
trends.