Home / Obligation register / day-hospital
F2025L00414, Sch 2 item 1, reg 8AA.1
Day-hospital facilities are healthcare facilities
A day-hospital facility that meets the Act definition of healthcare facility. The Act definition of healthcare facility is extended to a day-hospital facility through paragraph (c).
Reader note for unit 17: this provision sits in Schedule 2, under Adverse event reporting. The first action it calls for is to review the Act definition. The evidence it names first is a facility status determination with the legal basis. The provision read on this page is Sch 2 item 1, reg 8AA.1. It is unit 17 of 21 in the register.
What the provision requires
The Act definition of healthcare facility is extended to a day-hospital facility through paragraph (c). The item does not create a separate reporting duty; it brings that facility type into the definition the duty uses.
Source pointer: reg 8AA.1.
What it means in practice
The reporting duty attaches to healthcare facilities. This item brings day-hospital facilities into that definition for the Stage 1 reporting provisions.
A facility should confirm its status against its licensing arrangements. The term is prescribed but not defined in the Act or the principal regulations, so the boundary is ordinary meaning and licensing rather than a statutory list. The text does not list which day-hospital services are in or out.
Source pointer: reg 8AA.1.
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 facility status determination with the legal basis. The duty depends on being a healthcare facility.
- The licence or accreditation record. Supports the status determination.
- A named reporting officer. The duty needs an owner before the first event.
Source pointer: reg 8AA.1. The artefacts are our suggested evidence, not a form prescribed by the instrument.
Common gaps
- Assuming a clinic is not a day-hospital facility.
- No documented status decision.
- A reporting officer named only after an event.
Preparation steps
- Review the Act definition.
- Record the determination.
- Name the reporting officer.
Dates that matter for this unit
| Date | What happens | Note |
|---|---|---|
| 2026-03-21 | Schedule 2 Part 1 commenced | s 2 table item 3 |
Source pointer: s 2 table item 3.
Where it sits
- Reportable devices from Stage 1, reg 8AA.2.
- Report content and timing, reg 8AA.3.
Questions this provision raises
Is every clinic a day-hospital facility?
The item prescribes a day-hospital facility for the Act definition. Neither the Act nor the principal regulations defines the term, so the facility should apply its ordinary meaning and its licensing arrangements. It does not say that every clinic is one.
When did this start?
Schedule 2 Part 1 commenced on 21 March 2026. The commencement table item is the source for that date.
Does the item create a reporting duty by itself?
No. It adds a class of facility to the Act definition. The reporting duty comes from the Act and from regulations 8AA.2 and 8AA.3.
Source pointer for the page
- Citation
- Sch 2 item 1, reg 8AA.1
- 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.1
- Requirement
- reg 8AA.1
- Evidence
- reg 8AA.1
- Dates
- 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: Report Class III and Class 4 IVD events.