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F2025L00414, Sch 1 item 1, reg 9A.1(12)
Correct a database entry
The Secretary as database operator. The Secretary may correct model information where the sponsor, the manufacturer or another person acting for them cannot reasonably make the fix, or where a public health or safety interest favours the correction.
Reader note for unit 05: this provision sits in Schedule 1, under The database. The first action it calls for is to document the normal correction route and its failure modes. The evidence it names first is the failed or impractical correction attempt. The provision read on this page is Sch 1 item 1, reg 9A.1(12). It is unit 05 of 21 in the register.
What the provision requires
The Secretary may correct model information where the sponsor, the manufacturer or another person acting for them cannot reasonably make the fix, or where a public health or safety interest favours the correction.
Source pointer: reg 9A.1(12).
What it means in practice
The clause closes a gap. If the responsible party cannot fix an entry, or a safety issue makes speed matter, the Secretary can correct it directly.
A sponsor should first try to correct through the normal submission route and keep the attempt. The public health limb is a safety route, not a routine edit. The text does not define a service level or require the Secretary to notify the sponsor before a correction.
Source pointer: reg 9A.1(12); reg 13C.4.
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.
- The failed or impractical correction attempt. The first limb depends on the sponsor being unable to correct.
- A safety assessment supporting the public health route where used. The second limb is about health or safety, not convenience.
- The corrected entry and the date. Shows the record now reads correctly.
Source pointer: reg 9A.1(12). The artefacts are our suggested evidence, not a form prescribed by the instrument.
Common gaps
- Using the safety route for a routine typo.
- No record of why the sponsor could not correct the entry.
- A correction with no notification to the device owner.
Preparation steps
- Document the normal correction route and its failure modes.
- Give the quality lead a short safety-route note.
- Keep a correction log with the clause relied on.
Dates that matter for this unit
| Date | What happens | Note |
|---|---|---|
| 2025-03-25 | Schedule 1 commenced | s 2 table item 2 |
Source pointer: s 2 table item 2.
Where it sits
- Accuracy duty, reg 13C.4.
- Removal on accuracy grounds, reg 9A.1(9).
Questions this provision raises
Who can ask for a correction?
The clause gives the power to the Secretary. A sponsor or manufacturer normally makes the correction itself. The Secretary can act where that is not possible or practicable, or where public health or safety requires it.
Is the sponsor told before a correction?
The text does not require notice. A working relationship should include a notification, but it is not a stated obligation. Keep the sponsor's own record of the entry so a change can be detected.
Does a correction need evidence?
The clause does not prescribe evidence. Good practice is to keep the source of the correct value, the reason the normal route failed and the date of the correction. That record is what an auditor will ask for.
Source pointer for the page
- Citation
- Sch 1 item 1, reg 9A.1(12)
- 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 9A.1(12)
- Requirement
- reg 9A.1(12)
- Evidence
- reg 9A.1(12)
- Dates
- s 2 table item 2
- 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: Publish the database without representative data.