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What must a healthcare facility report from 1 April 2028?
From 1 April 2028 the chief executive officer of a healthcare facility must report adverse events involving Class IIa, Class IIb, Class III, Class 3 IVD and Class 4 IVD devices to the Secretary. A death or serious deterioration is reported within 10 days. An intervention or treatment case is reported within 45 days. The report goes in an electronic form.
The short answer above is the direct answer. The detail below carries the clause and the date.
Which devices are in the expanded list?
Schedule 2 item 2 replaces the Stage 1 list with Class IIa, Class IIb, Class III, Class 3 IVD and Class 4 IVD devices. The Stage 1 list covered Class III and Class 4 IVD devices. The expansion is the item that commences on 1 April 2028. It covers non-implanted devices in those classes as well as implanted ones.
Who reports, and to whom?
The Act puts the duty on the chief executive officer (however described) of the healthcare facility. The report goes to the Secretary. The Act requires the name or a description of the device and a description of the matters in section 41JM(2), (3) or (4). The regulation adds the healthcare identifier, the dates, the nature of the deterioration and the manufacturer name if known.
When does the Commonwealth duty not apply?
Act section 41JM(7) says the duty does not apply if the CEO has already reported the same matters to the head of the Australian Commission on Safety and Quality in Health Care, 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.
What starts the 10-day clock?
The day of the death, or the day the serious decline in the person’s health is first spotted. It does not start on the day the quality committee meets or the day the report is drafted. A same-day triage route is the practical control.
What must the report contain?
The healthcare identifier assigned to the facility, the relevant dates, how the person’s health declined, and the manufacturer’s name if the chief executive officer knows it. The content requirements sit in regulation 8AA.3(1).
Which channel is allowed?
A digital channel. Fax and scanned paper do not qualify, and a PDF of a paper form is still a scan. The facility should test the channel before the first live event rather than during one.
What happens to the instrument after 1 April 2028?
The Federal Register title record lists a possible future repeal on 2 April 2028 under section 48A of the Legislation Act 2003. A continuation would change that. A facility should note the entry and check the register before treating the Stage 2 date as permanent.
Questions
Does Stage 2 change the 10 and 45 day clocks?
No. The clocks in regulation 8AA.3 stay. Stage 2 changes the device list they apply to, not the periods.
Can a state health department report replace the Commonwealth report?
It can, if the CEO has already reported the same matters to the head of the state or territory health department under section 41JM(7). The report must cover the matters in section 41JM(2), (3) or (4). Keep the evidence and do not assume a different report covers it.
Is a day-hospital facility covered?
Yes. Regulation 8AA.1 brings a day-hospital facility into the Act definition of healthcare facility through paragraph (c). A facility should record its status determination.
Can a near miss be reported?
The regulation defines the reportable device classes and the content of a report. The event test comes from the Act. A near miss that does not meet that test is not a report under this provision, but it may still belong in the facility safety system.
The unit pages behind this answer
- Class IIa and IIb devices join on 1 April 2028, Sch 2 item 2; s 2 table item 4.
- Report within 10 or 45 days, electronically, Sch 2 item 1, reg 8AA.3(1) to (3).
- Day-hospital facilities are healthcare facilities, Sch 2 item 1, reg 8AA.1.
Check your own device
The free check returns the start day, the 30th day and the privacy step for a class and certificate branch. It does not decide whether a device is in scope. How the record is built.
Not legal advice; does not certify. Source: F2025L00414, Federal Register of Legislation, retrieved 2026-10-20.