New mandatory medical device reporting: key implications for facilities and sponsors

From 21 March 2026, healthcare facilities in Australia are now required by law to report adverse events resulting in death or serious deterioration in a patient's health associated with the use of high-risk medical devices to the Therapeutic Goods Administration (TGA). These new obligations apply to public and private hospitals and day hospital facilities, but do not include general practices or residential aged care facilities.

New obligations

The voluntary reporting period has now concluded and, under Stage 1 of the new mandatory reporting requirements, healthcare facilities are must report any adverse events associated with Class III medical devices and Class 4 in vitro diagnostic medical devices (Reportable Medical Device) under Part 4-8A of the Therapeutic Goods Act 1989 (TG Act) and Part 8AA of the Therapeutic Goods (Medical Devices) Regulations 2002 (Cth).

These obligations apply to high-risk medical devices such as hip, knee or shoulder prostheses, prosthetic heart valves, pacemakers or in vitro diagnostic tools that pose a high public health risk, for example a blood donor screening test for HIV (although the TGA recommends reporting healthcare facilities focus on the event outcome, rather than device classification).

The rationale for the new obligations is to encourage information sharing between healthcare facilities and the TGA, to support the detection of potentially critical safety signals and earlier intervention in responding to emerging risks. Failure to comply carries a maximum civil penalty of 30 penalty units (up to $9,900 from 1 July 2025).

When and what to report

The table below provides a quick reference guide to the triggers and timing for a report under the new obligations, and what must be reported.

"Serious deterioration" in the state of the health of a person is not defined in the Regulations. The TGA's guidance suggests that it has the same meaning as it does for sponsors' reporting obligations. That is, a serious deterioration in health will include a life-threatening illness or injury, permanent impairment of a body function, permanent damage to a body structure, or a condition necessitating medical or surgical intervention to prevent permanent impairment of a body or function or permanent damage to a body structure.

If a patient is being treated for a serious deterioration in their health as a consequence of the use of a medical device, the healthcare facility is required to report, regardless of whether the use of the medical device occurred at the healthcare facility.

How to report

The legislation requires that mandatory reports must be provided in an electronic form "other than a fax or a scanned document" (which will not be accepted by the TGA).

The TGA requires reports to be submitted via the Adverse Signal Detection and Event Reporting (ASDER) system. The TGA has progressively rolled out ASDER and each healthcare facility or centralised reporting body should be registered. Any facilities that do not have access should contact the TGA. Reporting of adverse events from public hospitals in some States and Territories may also be centralised with the relevant State health department (provided that the statutory timeframes can be met).

The TGA has indicated that successfully lodged ASDER reports will be receipted by email. Healthcare facilities should retain proof of lodgement of each report.

The Incident Reporting and Investigation Scheme (IRIS) remains available on the TGA's website and can be used by anyone. Using this system will meet a healthcare facility's mandatory reporting obligations if ASDER cannot be accessed.

Who is responsible and consequence for failure to report

For each healthcare facility, the new obligations apply to its CEO "however described" – meaning, in effect, the facility's most senior executive officer. Civil penalties for non-compliance will also apply to the CEO if the healthcare facility fails to provide a mandatory report in accordance with the requirements.

The penalties for non-compliance of healthcare facilities with the new mandatory reporting regime are relatively modest, compared to those imposed on sponsors, but they are personal to the CEO. Failure to report carries a maximum civil penalty of 30 penalty units, which at time of writing amounts to up to $9,900 from 1 July 2025. The TGA has indicated it considers that notification of (or a failure to notify) each individual incident will be a "report" for the purposes of the legislation. This means that it is incumbent on healthcare facilities captured by the legislation to have proper systems in place to ensure that the new obligations can be met.

The CEO is not required to report if the matters have already been reported to:

• the CEO of the Australian Commission on Safety and Quality in Health Care;

• the head of a State or Territory health department; or

• any other person prescribed by regulations (no such persons are currently prescribed).

Five implications for medical device sponsors

1. Sponsors should seek proactive engagement and monitor DAEN

The new mandatory disclosure obligations do not impose a requirement on healthcare facilities to report adverse events associated with Class III medical devices or Class 4 in vitro diagnostic medical devices to the sponsor or manufacturer directly. While there has never been a formal obligation for facilities to report adverse events directly to sponsors, there is now likely to be an increased level of direct reporting to the TGA about which sponsors may not be immediately aware.

A direct reporting pathway previously existed between practitioners and sponsors under the Authorised Supply Rules, whereby practitioners who were supplying unapproved therapeutic goods were required to report adverse events and defects to both the TGA and the sponsors within 15 days. This formal reporting requirement to sponsors was removed in 2025, although health practitioners supplying unapproved medical devices under an authority must still report defects and adverse events (as defined by the relevant rules) to the TGA.

The TGA has confirmed it will use the data for signal detection and trend analysis. The TGA's post-market surveillance team will generally engage with sponsors when adverse events are reported to the TGA, and may disclose information to sponsors about the nature of the adverse events where such disclosure "is necessary to ensure the safe use of a therapeutic good", pursuant to section 61(7)(a) of the TG Act.

Sponsors should seek proactive engagement with the post-market surveillance team, and should also actively monitor the Database of Adverse Event Notifications (DAEN), which is the publicly available database of adverse event reports.

Further, sponsors should also proactively engage with healthcare facilities and practitioners to seek voluntary direct reporting. This is consistent with sponsors' obligations at law, including to conduct appropriate post-marketing surveillance and, where active collection, review and investigation (where appropriate) of all available information (including complaints and event reports) about its medical devices.

2. Penalties remain severe for sponsors and obligations remain the same

There has been no change in sponsor obligations for reporting adverse events, which are imposed as conditions on the inclusion of a kind of medical device in the Australian Register of Therapeutic Goods.

Sponsors must report: a serious threat to public health within 48 hours of becoming aware of the occurrence; death or serious deterioration in health within 10 days of becoming aware; where recurrence of an incident might lead to death or serious deterioration within 30 days; and any other case within 60 days.<^[1]/p>

Failure to report adverse events may give rise to significant penalties including up to 12 months or 1,000 penalty units (or both), and for a body corporate up to 30,000 penalty units.

Medical device sponsors and manufacturers are still required to report through IRIS.

3. Sponsors still need to report

Sponsors still have reporting obligations regardless of whether a third-party has already reported the adverse event to the TGA. The reporting obligations are triggered when a sponsor knows that certain information is of a kind that is reportable (including adverse events) and then the person fails to give that information to the TGA as required by the legislation.

It is irrelevant whether the source of the information is through its own complaint-handling system, information received from a healthcare facility about a mandatory report made to the TGA, an overseas regulator, media reports or even from DAEN. However, a sponsor is entitled to consider whether it has sufficient information to meet the reporting thresholds for a particular report before making the report (eg. ascertaining what device is involved in a report, if any, and whether the information is of a reportable kind).

There is no exemption from reporting obligations where the sponsor knows that a (now) mandatory report of an adverse event has been made by a healthcare facility to the TGA. The sponsor should consider reporting that adverse event in line with its obligations and all relevant time frames from when it first learnt of the event. There is potential for duplication of reporting of adverse events which may result in the risk of over-reporting if duplicate reports cannot be identified due to available information. This reinforces the need for a robust system for post-market surveillance and investigation.

4. TGA now has an independent benchmark for reporting

It is likely that medical device sponsors will now be subject to greater scrutiny by the TGA for timeliness and completeness of reporting in compliance with sponsors' mandatory obligations. We can expect the TGA will be proactive in reviewing and comparing the reports which are made by healthcare facilities and those which are made by sponsors.

5. Greater litigation and regulatory risk

The TGA has observed that, in the period 1 July 2023 to 30 June 2024, 92.4% of medical device-related reports were submitted by medical device manufacturers and sponsors, with only 7.6% of reports coming from healthcare facilities, clinicians and consumers. These figures may suggest adverse events for high risk devices like implantables have been underreported, given that healthcare facilities are generally where the events were first observed.

It is also relevant to note that implantable devices also give rise to complex considerations associated with surgical implantation (including the expertise and experience of the healthcare professionals implanting, revising or explanting the device). These factors, and the absence of a clear pathway for reporting (and associated consequences for non-reporting), are likely to have contributed to the perceived underreporting.

The TGA has estimated that it may only be receiving 5% of reportable medical device adverse events.

Paired with the public-facing DAEN register, the mandatory reporting regime is likely to significantly increase not only the volume of reported adverse events but the level of interest of patients, lawyers and regulators (including overseas regulators) in the medical devices associated with these events.

Future of the regime

The commencement of the mandatory reporting obligations for healthcare facilities of high risk medical devices (Class III medical devices and Class 4 in vitro diagnostic medical devices) on 21 March 2026 is Stage 1 of the new reforms (following on from the prior voluntary reporting transitional period that commenced on 21 March 2025).

Stage 2 of the reforms commences on 1 April 2028 and is already part of the amending legislation. This stage will extend the mandatory reporting obligations to medium-risk medical devices, to cover:

• Class IIa, IIb and III medical devices;

• Class 3 and 4 IVD medical devices.

We note at the time of publication the TGA's guidance appears to suggest that mandatory reporting of near-miss adverse events and treatment of serious injury arising from reportable medical devices may only become mandatory at from Stage 2, 1 April 2028. However, based on our review of the legislation this is not accurate and these mandatory obligations are already in place.

The final stage, Stage 3 of the reforms, will commence on 1 April 2030 and will further expand the reporting obligations to include treatment for serious injury. This will require healthcare facilities to report all adverse events, near adverse events, and provisions of treatment for Class IIa and above devices to the TGA. The amending legislation does not incorporate this Stage 3.