This article applies to public and private hospitals across Australia.
Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023 (Cth)
On 21 March 2025, the remaining provisions of the Therapeutic Goods Amendment (2022 Measures No. 1) Act 2023 (Cth) (the Amending Act) amended the Therapeutic Goods Act 1989 (Cth) (the Act).
What’s changed?
The Amending Act has introduced a new mandatory reporting requirement to the Act, for public and private hospitals regarding adverse events involving certain medical devices.
Further Information
New mandatory reporting of adverse events for healthcare facilities
The Amending Act has introduced section 41JM to the Act which imposes a new mandatory reporting requirement on the chief executive officer of a healthcare facility (being a public hospital or a private hospital or any other prescribed facility). The chief executive officer is required to report to the Secretary of the Department of Health and Aged Care (Department) in the event that:
- a reportable medical device is used in the facility and the use of the device has resulted in the death, or a serious deterioration in the health, of a person while the device is used in the facility; or
- a reportable medical device is not used in the facility because of the intervention of a person in the facility and the use of the device, if the device were used, would result in, or would be likely to result in, the death, or a serious deterioration in the health, of a person; or
- a health practitioner provides treatment to a person in the facility for a serious deterioration in the health of the person and the use of a reportable medical device has resulted in the serious deterioration in the health of the person.
Section 41JM requires the report to be provided to the Department in the prescribed period and in the prescribed manner.
It is important to note that the key operational details regarding the type of medical device captured by new section 41JM and also the form and timing of the report is prescribed in relevant parts of the Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 (Cth) which will only commence on 21 March 2026. As a result, this practically means that there is a ‘transitional period’ for healthcare facilities until 21 March 2026. Essentially, the new mandatory reporting requirement in section 41JM will only be ‘switched on’ and become operational from 21 March 2026.
We note that failure to report under the new section 41JM incurs a sanction of 30 penalty units (currently $9,900.00).
What you should do
If your organisation is a public hospital or a private hospital, your organisation’s chief executive officer should be made aware of the new mandatory requirement to report about adverse events involving certain medical devices discussed above, that will operationally apply from 21 March 2026.
