Labelling and Instructions for Use Requirements in Australia

1. Key takeaways

The statutory requirements for information supplied with devices in Australia are Essential Principle clause 13 (including 13.1–13.6) together with the accompanying 13A, 13B and 13C. There are three hard thresholds: the information must be in English; the type height must be not less than 1 mm; and none of the 14 items of mandatory information listed in the clause 13.3 table may be omitted. Each of the three thresholds operates independently, so a label can satisfy two of them and still fail on the third, which is why the labelling review must test all three against the artwork rather than treating them as a single combined condition.

• Clause 13.1(3): information must be in English, and other languages may be provided in addition.
• Clause 13.1(5): the type height must be not less than 1 mm.
• Clause 13.1(6): symbols and identification colours outside device standards must be explained.
• The clause 13.3 table lists items 1 to 14 of mandatory information, running from the manufacturer’s name and address through to “for export only”.
• The table notes point expressly to clause 10.2, which separately requires certain information, including the sponsor’s name and address.
• Clause 13.4(3) item 20 requires the instructions for use of reusable devices to state the reprocessing steps and the number of safe reuses.

2. Legal basis

Therapeutic Goods (Medical Devices) Regulations 2002 (F2002B00237, compilation F2026C00883): the Essential Principles appear in Schedule 1 Part 2; the provisions on information supplied with devices are clause 13 — 13.1 general requirements, 13.2 location, 13.3 table of specific requirements, 13.4 instructions for use, and 13.5–13.6 UDI-related matters; there are also 13A (patient information for implantable devices), 13B (software version and build numbers) and 13C (UDI rules). Read together, the clauses cover both the physical label and the accompanying documentation, so the review cannot stop at the artwork on the packaging.

Language and layout: clause 13.1(3) — information must be in English, and other languages may be provided as well; clause 13.1(5) — the type height requirement is not less than 1 mm; clause 13.1(6) — symbols and identification colours outside device standards must be explained.

Mandatory information in the clause 13.3 table (items 1–14): the manufacturer’s name or business name and address; the intended purpose, intended users and patient population; information sufficient to identify the device (or the contents of the packaging); handling and storage requirements; warnings, limitations and precautions; special operating instructions; single-use identification; custom-made identification; identification reserved for clinical investigation or performance evaluation; the word STERILE and the sterilisation method for sterile devices; batch, lot or serial number; use-by date for safe use (otherwise the manufacturing date); and “for export only”, among others.

The table notes state expressly that, beyond the content of the table, clause 10.2 also requires certain information to be provided (including the sponsor’s name and address). The note exists precisely because reviewers see labels that pass the table check but omit the sponsor details, and the omission only surfaces late in the review.

Reusable devices: clause 13.4(3) table item 20 — the instructions for use must set out the process that allows reuse (cleaning, disinfection, packaging and, where necessary, re-sterilisation) as well as the number of times the device can be safely reused. Both halves of the requirement carry equal weight, and the stated number must correspond to the verification data held by the manufacturer.

3. Expert insights

Insight 1: the 1 mm type height is a hard quantitative threshold. The 1 mm in clause 13.1(5) is not a suggestion. Information presentation on small packaging, implant cards and software interfaces frequently loses ground under this clause, especially where design teams carry over European aesthetics with very small type sizes, and once the artwork is printed or shipped the correction cost rises sharply.

Insight 2: the clause 13.3 table does not cover every information obligation. The table notes single out clause 10.2 as a reminder — information such as the sponsor’s name and address is required under a separate clause. A labelling checklist built only on the clause 13.3 table will miss the sponsor information, and the gap will only surface once the reviewer checks the artwork against the full set of clauses rather than the table alone.

Insight 3: reusable devices must state the number of safe reuses. Clause 13.4(3) requires not only the reprocessing steps but also the number of reuses. Stating only that the device is reusable, or describing the process without the number, does not satisfy that requirement, and the number given must be defensible against the reprocessing validation data on file.

4. Practical recommendations

• Maintain a labelling checklist that merges the 14 items of the clause 13.3 table with the clause 10.2 information into a single list of roughly 16 items, ticked off one by one.
• Write the mandatory constraints of English plus a type height of at least 1 mm into the design specifications, and include the symbol explanation table in the packaging design file.
• Give the instructions for use of reusable devices dedicated fields for the reprocessing steps and the number of reuses, mapped to the verification data.
• Sequence the UDI-related items (13.5, 13.6) against the four mandatory compliance dates, and update them together with label revisions so no revision ships with stale UDI information (see article 45 for details).

5. Verification checklist

• □ Labels and instructions for use are in English with a type height of not less than 1 mm, checked on the final artwork
• □ The 14 items of the clause 13.3 table have been checked one by one
• □ Sponsor information required by clause 10.2 has been added
• □ Non-standard symbols and identification colours carry explanations
• □ Reusable devices state the reprocessing steps and the number of safe reuses

How GRZAN can help. GRZAN provides medical device and IVD registration, quality system, authorised representative and local testing support for the Australian market. Our team prepares TGA-compliant CTOs and evidence dossiers, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com