Class I Sterile, Measuring and Reusable Devices in Australia

1. Key takeaways

“Class I” in Australia is not a single unified pathway: Class I devices that are neither sterile nor have a measuring function require only a declaration of conformity made by the manufacturer under Schedule 3 clause 6.6, whereas Class I devices that are sterile or have a measuring function must obtain conformity assessment documents. This distinction directly determines project timelines and cost, because the declaration route requires no Secretary evaluation while the conformity assessment route requires third-party or TGA assessment before the application can be lodged.

• Schedule 1 Part 1 Division 1 item 1 covers Class I non-sterile, non-measuring devices: a declaration of conformity made by the manufacturer under Schedule 3 clause 6.6 of the Therapeutic Goods (Medical Devices) Regulations 2002.
• Division 2 items 1–7 cover Class I sterile or measuring devices, which must obtain conformity assessment documents.
• Sterile devices proceed under Schedule 3 Part 1 (full quality system, excluding clause 1.6) or Part 4 (production quality assurance).
• Measuring devices that are not sterile proceed under Part 1 (excluding clause 1.6), Part 3 (verification procedures), Part 4 or Part 5 (product quality assurance).
• Where a system or procedure pack (SOPP) is supplied sterile, quality management system and product assessment documents must additionally be obtained under the Schedule 3 Part 2 table, pursuant to section 7(2) of the Determination.
• Reusable surgical instruments are Class I under clause 3.2(4), yet clause 13.4(3) item 20 still requires the reprocessing steps and the number of safe reuses.

2. Legal basis

Therapeutic Goods (Medical Devices—Information that Must Accompany Application for Inclusion) Determination 2018 (F2018L01410, compilation version 13, effective 1 December 2025): Schedule 1 Part 1 Division 1 item 1 (Class I non-sterile, non-measuring) — a declaration of conformity made by the manufacturer under Schedule 3 clause 6.6 of the Therapeutic Goods (Medical Devices) Regulations 2002; Division 2 items 1–7 (Class I sterile or measuring) — conformity assessment documents must be obtained. The Division 1 and Division 2 split is therefore the first thing to resolve for any Class I product, before any other evidence planning begins.

Procedural limits of the sterile pathway: Division 2 item 1 — sterile devices proceed under Schedule 3 Part 1 (full quality system, excluding clause 1.6) or Part 4 (production quality assurance); measuring devices that are not sterile proceed under Part 1 (excluding clause 1.6), Part 3 (verification procedures), Part 4 or Part 5 (product quality assurance). The Division thus fixes in advance which Parts of Schedule 3 can be relied on for each attribute, leaving no room to mix and match procedures outside those entries.

Where a system or procedure pack (SOPP) is supplied sterile, quality management system and product assessment documents must additionally be obtained under the Schedule 3 Part 2 table, pursuant to section 7(2) of the Determination. The obligation is additional precisely because the sterile presentation of the pack raises questions that the pack assembly alone does not answer.

Classification of reusable surgical instruments: Schedule 2 clause 3.2(4) of the Therapeutic Goods (Medical Devices) Regulations 2002 classifies them as Class I; the definitions appear in the Dictionary. The classification settles only the registration burden, and it leaves the instruction obligations untouched.

Reuse instruction requirement: Essential Principle Schedule 1 clause 13.4(3) table item 20 — the process allowing reuse (cleaning, disinfection, packaging and, where necessary, re-sterilisation) as well as the number of safe reuses must be stated. The clause applies by virtue of the Essential Principles themselves, independently of how the instrument was classified for registration purposes.

3. Expert insights

Insight 1: the cost differential within Class I can reach several multiples. Non-sterile, non-measuring devices proceed under the Part 6 declaration of conformity without Secretary evaluation, while sterile or measuring devices proceed under one of Parts 1, 3, 4 or 5, which require third-party or TGA assessment. Quotations and schedules must first confirm these two attributes, because a single added attribute changes not only the price but also the parties involved in the assessment and the time needed before the application can be lodged.

Insight 2: the measuring function is an independent upgrade trigger. A Class I device with a measuring function must obtain conformity assessment documents even if it is not sterile. Many companies quote on the basis of an ordinary Class I device and discover at the submission stage that system evidence is required, which forces a rushed search for assessment bodies at exactly the point where the schedule has no room left for them.

Insight 3: reusable surgical instruments are Class I, yet reuse instructions remain a hard requirement. Clause 3.2(4) classifies them as Class I, but clause 13.4(3) requires the instructions for use to state the reprocessing steps and the number of reuses. A low classification does not mean low instruction requirements, and the two questions must be answered separately rather than assuming one follows from the other.

4. Practical recommendations

• Confirm three attributes before quoting: whether the device is sterile, whether it has a measuring function and whether it is reusable, and determine the conformity assessment procedure and the evidence list accordingly.
• For SOPP projects, check section 7(2) and the two-column requirements of Schedule 3 Part 2 separately.
• Complete reuse-number verification for reusable devices early, and map the verification report to the instruction clauses one by one.
• For sterile devices, check the sterilisation and packaging standards at the same time (see article 29 for details).

5. Verification checklist

• □ Whether the device is sterile, has a measuring function and is reusable has been confirmed
• □ The applicable Part of Schedule 3 has been determined from the attributes
• □ SOPP projects have been checked against section 7(2) and Schedule 3 Part 2
• □ Reuse-number verification has been completed for reusable devices
• □ The instructions for use state the reprocessing steps and the number of 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