TGA Medical Device Information Disclosure Consultation Closes 2 October 2026: Proposed Legislative Change to Expand Post-Market Review Disclosure

News: TGA consultation on sharing more information about medical devices closes 2 October 2026

Published: 9 October 2026, 13:31  |  Topic: UDI, labelling and post-market surveillance

On 13 August 2026, the Australian Therapeutic Goods Administration (TGA) launched a public consultation on improving the sharing of information about the safety, quality and performance of medical devices. The consultation ran from 13 August 2026 and closed on 2 October 2026. TGA published an explanatory notice in the consultations section of its website and opened an online submission channel on its consultation platform, the TGA Consultation Hub.

According to TGA, the core of the proposed change is to allow the regulator, after completing a post-market review or investigation, to provide more information to the public, particularly where the conclusion of a review concerns the safety, quality, performance or use of a medical device. TGA states that this direction is consistent with the intent of An Action Plan for Medical Devices (the medical device reform action plan) and is aligned with the requirements of the World Health Organization (WHO) Global Benchmarking Framework.

The legal basis sits in section 61 of the Therapeutic Goods Act 1989. TGA notes that this section currently permits external disclosure only in limited specified circumstances. The consultation was therefore intended to collect views on expanding the ability to disclose information under the law. Feedback was sought on two questions in particular:

• Whether information about a medical device that is under post-market review or investigation should be made public; and
• What types of information should be disclosed while a review or investigation is in progress.

The scope of the consultation should be distinguished carefully. It addresses TGA's regulatory information disclosure at the post-market stage. It does not involve pre-market approval pathways, classification rules or adjustments to registration fees, and it does not impose new compliance obligations on companies. TGA also noted that it had previously consulted separately on transparency of information about medical device supply interruptions, with the results published on its consultation platform; the present consultation focuses on public disclosure of review and investigation information.

On timing and process, TGA states that reading and completing the consultation page takes approximately 10 minutes, while a deeper reading of the consultation paper and a detailed written response may take longer. After the consultation closes, submissions will be collated and reviewed, and the results will be published on the same consultation platform page. As of the verification date for this report, TGA had not published the final conclusions of this consultation round, and had not released any proposed legislative amendment text.

TGA made available a full consultation document, Public consultation paper - Sharing more information about medical devices - V1.0, and a dedicated email address, devicereforms@tga.gov.au, for those unable to submit online. All content cited in this article comes from public information published on the TGA website consultations section and consultation page as of 9 October 2026.

Sources and scope of verification

Sources:

• Therapeutic Goods Administration (TGA) - Consultation on improving the sharing of information about medical devices (published 13 August 2026): https://www.tga.gov.au/news/news-articles/consultation-improving-sharing-information-about-medical-devices
• Therapeutic Goods Administration (TGA) - Consultation on sharing more information about medical devices: https://www.tga.gov.au/news/consultations/consultation-sharing-more-information-about-medical-devices
• TGA Consultation Hub - Sharing information about the safety, quality and performance of medical devices: https://consultations.tga.gov.au/tga/sharing-information-device-performance/
• Therapeutic Goods Administration (TGA) - An Action Plan for Medical Devices: https://www.tga.gov.au/resources/publication/corporate-reports/medical-devices-reforms-action-plan-medical-devices

Verification scope and access date: This verification reviewed the TGA news release, consultation explanation page, TGA consultation platform page and the public page for the action plan described above, accessed on 9 October 2026 (Asia/Shanghai). Dates, section numbers and consultation questions follow the original text on the official pages; no second-hand media reports were used as a basis for conclusions.

Applicability note: This article is an interpretation of publicly available TGA consultation information. The consultation remains at the stage of submission collection and review. It does not constitute a conclusion or commitment regarding any specific product, company or registration application, and it does not mean that the relevant amendments have entered into force. Final rules are subject to the legislative documents and official texts subsequently published by TGA, and the information may change as official updates are issued.

AIMEILI Regulatory Interpretation

The consultation matters less for what it changes today than for the direction of travel it confirms: TGA is seeking a broader statutory footing to publish information about devices while reviews and investigations are still open, not only after they conclude. The mechanism proposed is an expansion of the disclosure power under section 61 of the Therapeutic Goods Act 1989, which at present only supports disclosure in narrowly defined circumstances. If the amendment proceeds, the practical trigger for publication would be the existence of a post-market review or investigation, and the central policy question would be what TGA may publish during, rather than after, that process.

Three points deserve attention from a regulatory affairs perspective. First, the stated alignment with the WHO Global Benchmarking Framework signals that this is part of a broader transparency expectation for national regulators, not a one-off local initiative; similar disclosure practices are emerging across mature markets, which argues for treating device-level transparency as a global operating assumption rather than an Australian exception. Second, no new compliance obligations are being created at this stage, and pre-market pathways, classification rules and fees are explicitly out of scope, so the immediate effect on registration strategy is limited. Third, the consultation had not, as of verification, produced a final outcome or draft legislative text, so any assumption about what TGA will ultimately publish, on what timeline, and with what notice to sponsors, remains unconfirmed.

It is also useful to separate this consultation from the earlier round on supply-interruption transparency. The two tackle different information problems: one concerns continuity of supply, the other concerns the findings and status of post-market reviews and investigations. Sponsors who responded to the earlier consultation should not assume their positions carry over automatically.

Business Impact

Reputational exposure during open reviews. If TGA gains the ability to disclose information about devices under active review or investigation, a sponsor may face public scrutiny before any finding is finalised. That shifts the communications burden earlier in the process and makes parallel tracking of TGA correspondence, review milestones and external messaging essential.

Higher evidentiary standard for post-market files. Information that may be summarised for the public is only as strong as the underlying records. Complaint handling, corrective and preventive action files, post-market surveillance reports, periodic safety update reports and vigilance submissions should be complete, internally consistent and written in language that can survive paraphrasing in a public notice.

Commercial and contractual considerations. Distributors, importers and contract research organisations may need to reassess confidentiality clauses, incident notification flows and joint response protocols, since disclosure could affect product positioning in the Australian market even where the device remains on the register.

Engagement window. The formal consultation closed on 2 October 2026, but the outcome and any draft amendment text are still pending. Companies with material Australian revenue or a significant device portfolio should monitor the TGA consultation platform page for the published results, and prepare internal positions on device naming, the level of detail disclosed during open reviews, and the notice given to sponsors before publication.

Practical next steps. Map which products are currently or likely to be subject to post-market review; verify that safety, quality and performance claims in technical documentation are supported by retrievable evidence; brief local affiliates and distributors on a coordinated response approach; and record any internal positions taken while the legislative position remains open.

Until TGA publishes the consultation outcome and any amending instrument, this remains a proposed change. Registration strategies, labelling and UDI decisions should continue to be based on the law and guidance currently in force.