TGA Opens Consultation on Improving Information Sharing About Medical Devices
The Therapeutic Goods Administration has opened a consultation on improving the sharing of information about medical devices.
The consultation was published on 13 August 2026 and is open from 13 August to 2 October 2026. During this period, stakeholders can make submissions through the TGA consultation hub.
Purpose of the Consultation
The consultation seeks feedback on TGA proposals to improve the sharing of information about the safety, quality and performance of medical devices.
The proposed changes are intended to provide more information to the public after post-market reviews or investigations, particularly where findings relate to the safety, quality, performance or use of a medical device.
Alignment with the Medical Devices Action Plan
The TGA states that the proposed changes align with the intent of An Action Plan for Medical Devices.
That plan aims to provide more information to patients about the medical devices they use, supporting greater transparency and access to relevant safety and performance information.
Proposed Expansion of Information Sharing
The consultation focuses on proposals to expand the TGA’s ability to release information lawfully under section 61 of the Therapeutic Goods Act 1989.
The TGA is seeking feedback on whether information should be shared about medical devices included in a post-market review or investigation, and what types of information should be shared while such reviews or investigations are being undertaken.
Topics Covered
The publication identifies the consultation topic as proposed amendments relating to transparency of disruptions to the supply of a medical device, as well as safety monitoring and information.
This indicates a broader focus on improving the availability of information that may be relevant to patients, healthcare professionals, sponsors and other stakeholders when post-market issues arise.
Impact on Medical Device Manufacturers
For medical device manufacturers and sponsors active in Australia, the consultation is relevant because it may affect how information from post-market reviews and investigations is shared publicly.
Manufacturers should pay particular attention to:
post-market review and investigation outcomes;
safety, quality and performance information;
transparency expectations;
information that may be released under section 61;
safety monitoring processes;
communication with patients and healthcare professionals;
supply disruption transparency;
post-market documentation and evidence readiness;
stakeholder submissions during the consultation period.
For manufacturers and sponsors, the consultation reinforces the importance of robust post-market surveillance, clear safety monitoring and preparedness for increased transparency around device performance and regulatory findings.
