Home / Obligation register / reporting-deadlines

F2025L00414, Sch 2 item 1, reg 8AA.3(1) to (3)

Report within 10 or 45 days, electronically

The chief executive officer (however described) of a healthcare facility. The report must include the healthcare identifier, the relevant dates and the nature of the deterioration, and the manufacturer's name if known.

Reader note for unit 19: this provision sits in Schedule 2, under Adverse event reporting. The first action it calls for is to set a same-day triage. The evidence it names first is a dated report and acknowledgement. The provision read on this page is Sch 2 item 1, reg 8AA.3(1) to (3). It is unit 19 of 21 in the register.

Key date: 1 April 2028. Schedule 2 Part 2 commences and widens adverse event reporting to Class IIa, Class IIb, Class III, Class 3 IVD and Class 4 IVD devices. The UDI amendments commenced on 25 March 2025 and apply from each device general start day. The full date table.

What the provision requires

The report must include the healthcare identifier, the relevant dates and the nature of the deterioration, and the manufacturer's name if known. A death or serious deterioration is reported within 10 days of the death or first identification. An intervention or treatment case is reported within 45 days. The report must be given in an electronic form, not by fax or a scanned document.

Source pointer: reg 8AA.3(1)-(3); Act s 41JM(1), (5), (7).

What it means in practice

The Act sets the duty holder, the recipient and the core content. The regulation sets the added content, the clock and the channel. The short clock for death and serious deterioration is the centre of the duty.

The clock starts on the death or the first identification of the deterioration, not on the internal investigation. A facility should have a same-day triage route so the 10-day clock is not lost in a quality queue. The text does not prescribe a form; it prescribes an electronic manner. Before reporting, check whether the same matters have already gone to the ACSQHC or a state or territory health department, because that report can displace the Commonwealth duty under section 41JM(7).

Source pointer: reg 8AA.3(1)-(3).

Evidence to keep

An auditor or a regulator will ask for the record that shows the duty was met, not a description of the process. Keep these artefacts with the device or facility file.

A dated report and acknowledgement. Shows the report was made and when.
The triage record showing the trigger date. The clock runs from the event or first identification, not the meeting.
The investigation file. Supports the content of the report.
A channel test showing the form is electronic. Fax and scanned documents are excluded.
Evidence of any report to the ACSQHC or a state or territory health department. A prior report can displace the Commonwealth duty under Act s 41JM(7).

Source pointer: reg 8AA.3. The artefacts are our suggested evidence, not a form prescribed by the instrument.

Common gaps

Starting the clock at the meeting rather than the identification.
Fax or scanned PDF.
No healthcare identifier.
A report with no manufacturer name where it was known.

Preparation steps

Set a same-day triage.
Build the report template.
Test the channel.

Dates that matter for this unit

Date	What happens	Note
2026-03-21	Stage 1 commenced	s 2 table item 3
2026-03-21	10-day and 45-day clocks apply	reg 8AA.3(2)

Source pointer: reg 8AA.3(2); s 2 table item 3.

Where it sits

Reportable devices, reg 8AA.2.
Stage 2 expansion, Sch 2 item 2.
Act duty and alternative report, Therapeutic Goods Act 1989 s 41JM.

Questions this provision raises

When does the 10 days start?

On the day of the death, or the day the serious deterioration is first identified. It does not start on the day the report is drafted or the committee meets.

Is 45 days the default?

No. Ten days applies to a death or serious deterioration. Forty-five days applies to an intervention or a treatment case. The clause sets a separate period for each situation.

Can a scanned form be emailed?

No. The clause prescribes an electronic form other than fax or a scanned document. A PDF of a paper form is a scanned document. Use the electronic reporting channel.

Does a report to the state health department satisfy the Commonwealth duty?

It can. Act s 41JM(7) says the Commonwealth duty does not apply if the CEO has already reported the matters to the ACSQHC CEO, the head of a state or territory health department, or another prescribed person. Keep evidence of that report and check that it covers the same matters.

Source pointer for the page

Citation: Sch 2 item 1, reg 8AA.3(1) to (3)
Instrument: Therapeutic Goods Legislation Amendment (Australian Unique Device Identification Database and Other Measures) Regulations 2025 (F2025L00414)
Official text: https://www.legislation.gov.au/F2025L00414/latest/text
Binding party: reg 8AA.3
Requirement: reg 8AA.3(1)-(3); Act s 41JM(1), (5), (7)
Evidence: reg 8AA.3
Dates: reg 8AA.3(2); s 2 table item 3
Silent fields: Where the instrument does not state a form, a period or a frequency, this page says so rather than filling the gap.

Back to the register. Next: Class IIa and IIb devices join on 1 April 2028.