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F2025L00414, Sch 1 item 2, reg 10.7(1)(e)
Review a removal decision
A person affected by a decision under reg 9A.1(9), in practice. A decision under subregulation 9A.1(9) is added to the list of initial decisions in regulation 10.7.
Reader note for unit 07: this provision sits in Schedule 1, under The database. The first action it calls for is to add the review route to the removal procedure. The evidence it names first is the written decision and its date. The provision read on this page is Sch 1 item 2, reg 10.7(1)(e). It is unit 07 of 21 in the register.
What the provision requires
A decision under subregulation 9A.1(9) is added to the list of initial decisions in regulation 10.7. The review route in that regulation therefore applies to a decision to remove information that the Secretary considers incomplete or incorrect.
Source pointer: Sch 1 item 2; reg 10.7(1)(e).
What it means in practice
A removal on accuracy grounds can affect a sponsor's record. The amendment makes that decision reviewable in the same way as the other initial decisions in regulation 10.7.
A sponsor who disagrees with a removal decision should ask for the decision in writing, note the date and use the review route rather than resubmitting the same data. The text does not set a separate review period for this decision; regulation 10.7 supplies the route and its own time limits.
Source pointer: reg 10.7; reg 9A.1(9).
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 written decision and its date. The review clock runs from the decision.
- The review request and the grounds. Shows the decision was contested on the record.
- The outcome and any resubmission. Closes the loop with the device record.
Source pointer: reg 10.7. The artefacts are our suggested evidence, not a form prescribed by the instrument.
Common gaps
- Resubmitting without asking for reasons.
- Missing the review window because the decision arrived by phone.
- No copy of the decision in the device file.
Preparation steps
- Add the review route to the removal procedure.
- Name who may sign a review request.
- Keep the decision with the device record.
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
- Removal power, reg 9A.1(8) to (11).
- Initial decisions, reg 10.7.
Questions this provision raises
Which removal decisions can be reviewed?
A decision to remove information under subregulation 9A.1(9), which is the power to remove information the Secretary is satisfied is incomplete or incorrect. The amendment adds that decision to the regulation 10.7 list. Whether a refusal to remove is itself a decision under (9) is arguable, not settled.
Does the review route cover a representative request?
The item is specific to subregulation (9). A representative request is dealt with under subregulation (11). The review item does not purport to cover every removal decision.
What should the review request contain?
The text sends the reader to regulation 10.7 rather than setting a fresh form. Use the decision reference, the entry, the correct value and the evidence for it. Keep the request and the response with the device file.
Source pointer for the page
- Citation
- Sch 1 item 2, reg 10.7(1)(e)
- 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(9); reg 10.7(1)(e)
- Requirement
- Sch 1 item 2; reg 10.7(1)(e)
- Evidence
- reg 10.7
- 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: Provide the UDI on the device or pack.