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F2025L00414, Sch 1 item 6, reg 13C.4
Keep every entry accurate and current
The sponsor or manufacturer responsible for the entry, in practice. The clause is passive and does not name the party that keeps it current. Every entry in the database has to be correct and current, not only correct on the day it was filed.
Reader note for unit 14: this provision sits in Schedule 1, under The database. The first action it calls for is to set a quarterly review and an event-driven review. The evidence it names first is a review schedule with an owner. The provision read on this page is Sch 1 item 6, reg 13C.4. It is unit 14 of 21 in the register.
What the provision requires
Every entry in the database has to be correct and current, not only correct on the day it was filed.
Source pointer: reg 13C.4.
What it means in practice
The clause is short and continuous. It turns the database from a one-off filing into a maintained record.
The duty has no stated frequency and no stated tolerance. A sponsor should set a review cadence, tie it to label, model and manufacturing changes, and keep evidence of the review. The text does not say who must review or how often, so the procedure has to fill that gap.
Source pointer: reg 13C.4; reg 13C.2(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 review schedule with an owner. The clause is continuous and needs a cadence.
- Change records that triggered an update. Links the record to the event that changed it.
- A dated extract showing the current values. Proves the state of the record at a point in time.
- A correction log. Shows that inaccuracies were fixed, not only found.
Source pointer: reg 13C.4. The artefacts are our suggested evidence, not a form prescribed by the instrument.
Common gaps
- A submission treated as a one-off project.
- No link between the change control system and the database.
- No evidence of a periodic review.
- A review that checks only the identifier and not the 17 fields.
Preparation steps
- Set a quarterly review and an event-driven review.
- Connect change control to the UDI record.
- Keep a dated snapshot.
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 data set, reg 13C.3.
- Model changes, reg 13C.2(5).
Questions this provision raises
How often must the record be checked?
The text does not set a frequency. It requires accuracy and currency at all times. A quarterly check plus an event-driven update on a label, model, manufacturing or software change is a defensible procedure.
Who is responsible for accuracy?
The clause does not name a role. The sponsor or manufacturer that enters the information is the practical owner. A named individual and a deputy should be recorded in the procedure.
Is a screenshot enough as evidence?
A screenshot can show the state of the record on a date. It does not show that the values are correct. Pair it with the source documents for the fields that changed.
Source pointer for the page
- Citation
- Sch 1 item 6, reg 13C.4
- 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 13C.4
- Requirement
- reg 13C.4
- Evidence
- reg 13C.4
- 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.