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F2025L00414, Sch 1 item 1, reg 9A.1(13)
Publish the database without representative data
The Secretary as database operator. A sponsor or manufacturer that builds a public extract should keep representative information out in practice. The Secretary may release the whole database, or part of it, to the public.
Reader note for unit 06: this provision sits in Schedule 1, under Privacy and personal information. The first action it calls for is to ask which fields are public before submitting. The evidence it names first is a field map that marks public and non-public fields. The provision read on this page is Sch 1 item 1, reg 9A.1(13). It is unit 06 of 21 in the register.
What the provision requires
The Secretary may release the whole database, or part of it, to the public. Personal information in the representative categories has to stay out of that public view under the publication limit in the Act.
Source pointer: reg 9A.1(13); Act s 41CE(2)(b)-(c).
What it means in practice
Public device data supports traceability and patient safety. The clause keeps representative personal information out of that public view.
A sponsor should assume that device and model data can be published and should not put representative contact details into a field that will be published. A privacy officer should check any extract or feed the organisation builds from the public view, because a downstream copy can outlive a correction.
Source pointer: reg 9A.1(13); reg 9A.1(4)-(5).
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 field map that marks public and non-public fields. The publication decision turns on the field, not the page.
- A check that no representative information enters a public export. The prohibition follows the information into the extract.
- A takedown or correction route for downstream copies. A published copy can persist after the source changes.
Source pointer: reg 9A.1(13). The artefacts are our suggested evidence, not a form prescribed by the instrument.
Common gaps
- Publishing a representative name in a free-text field.
- Assuming a public extract is authoritative after a correction.
- No owner for a downstream copy.
Preparation steps
- Ask which fields are public before submitting.
- Strip representative fields from internal extracts.
- Add a refresh date to any local copy.
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
- The Act limit on publication, Therapeutic Goods Act 1989 s 41CE(2)(b)-(c).
- Representative consent, reg 9A.1(4) to (5).
Questions this provision raises
Is the whole database public?
The Secretary may publish all or part of it. The clause does not require publication of everything and does not list the public fields. Treat publication as a decision that may cover some fields only.
Can representative details appear in a public extract?
No. Personal information covered by section 41CE(2)(b) or (c) of the Act must not be made publicly available. That includes the representative categories. A public export should be checked field by field.
What about a copy someone downloads?
The clause binds the publication by the Secretary. It does not regulate a third party copy. The organisation should still avoid creating a copy that contains representative details and should refresh or withdraw a copy that does.
Source pointer for the page
- Citation
- Sch 1 item 1, reg 9A.1(13)
- 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(13)
- Requirement
- reg 9A.1(13); Act s 41CE(2)(b)-(c)
- Evidence
- reg 9A.1(13)
- 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.