IVD Classification Rules in Australia: Schedule 2A Explained

1. Key takeaways

The classification of in vitro diagnostic medical devices (IVDs) in Australia applies items 1.1–1.8 of Schedule 2A of the Therapeutic Goods (Medical Devices) Regulations 2002, with four classes: Class 1, 2, 3, and 4, plus a parallel tier for in-house IVDs prepared within a healthcare facility. The determination should run first along the two main axes of public health risk and individual risk, and only then consult the catch-all rule. Working the rules in their intended order matters because the earlier rules are specific and the later ones residual; a sponsor who starts from the catch-all tends to anchor on Class 2 and never tests the higher-risk questions that would have reclassified the product. The classification outcome then drives the conformity assessment route, the audit exposure, and the fee position, so the order of analysis is not a stylistic preference but a control on the accuracy of the entire pathway.

2. Legal basis

1. Therapeutic Goods (Medical Devices) Regulations 2002 (F2002B00237, compilation F2026C00883): the IVD classification rules are in Schedule 2A, comprising 8 items (cl 1.1–1.8), added by the amendment regulations of 2010 No. 25.
2. The skeleton of the rules: cl 1.1 transmissible agents of high public health risk → Class 4; cl 1.2 red cell antigens and blood grouping (ABO, RH, KEL, JK, FY and other high-risk blood group markers → Class 4) → Class 3; cl 1.3 moderate public health risk or high individual risk (including (fa) IVD companion diagnostics) → Class 3; cl 1.4 self-testing IVDs → Class 3 (except where results are not severe and require re-testing); cl 1.5 non-assay-specific quality control materials → Class 2; cl 1.6 reagents, instruments, specimen receptacles, and culture media → Class 1; cl 1.7 catch-all → Class 2; cl 1.8 export-only → Class 1.
3. Class 4 conformity assessment: regulation 3.6A (Class 4 IVDs) and regulation 3.6B (Class 4 in-house IVDs); procedures in Schedule 3 Part 6B (cl 6B.1–6B.3).
4. Additional requirements for Class 4 in-house IVDs (Schedule 3 Part 6B): establish a quality management system covering design, production, packaging, labelling, and final inspection; where blood, blood components, plasma derivatives, or human cell or tissue therapeutics are involved, satisfy the relevant TGA cGMP requirements and hold a manufacturing licence under section 122R(2) or (3), or obtain laboratory accreditation from NATA against ISO 15189 and comply with the NPAAC requirements for in-house IVDs; compile technical documentation; establish post-market monitoring and corrective systems; issue a declaration of conformity; and notify the Secretary for specified devices.
5. Exemption side: Schedule 4, item 2.10 (Class 1–3 in-house IVDs), items 2.10A and 2.19 (certain Class 4 in-house IVDs); fees in Schedule 5, items 1.14B and 1.14C.

3. Expert insights

Insight 1: Companion diagnostics are singled out as a Class 3 trigger. Item (fa) in Schedule 2A cl 1.3 places IVD companion diagnostics directly into Class 3. They are simultaneously listed under item 1.6 as one of the categories for which the unique product identifier (UPI) forms an element of the kind, which means companion diagnostics are managed entry by model and cannot be merged with other models (see articles 30 and 40 for details). The combined effect is that a companion diagnostic programme carries both a higher class and a more fragmented register structure than its technical similarity to other assays might suggest, and entry planning must account for both from the outset.

Insight 2: In-house IVDs have a separate channel and a separate cost base. Class 4 in-house IVDs follow Schedule 3 Part 6B, and the assessment body for the quality management system is designated as the Secretary, in contrast with conventional devices that rely on third-party or overseas bodies; Schedule 5 also establishes the separate fee items 1.14B and 1.14C. Laboratories accustomed to accreditation-based assurance should not assume that their existing certificates discharge these obligations; the statutory route names its own assessor and its own documentation expectations, and the two systems overlap without coinciding.

Insight 3: The Australian IVD classes have no official correspondence with the A/B/C/D classes of the EU IVDR. The two sets of rules differ in numbering and origin (the Australian rules date from the framework of the 2010 No. 25 amendment regulations); as a practical estimate, direct mapping is not reliable. Companies running multi-market submissions that map an IVDR Class C to an Australian Class 3 must re-verify item by item and cannot depend on a mapping table. Treating the European outcome as a hypothesis to be tested under Schedule 2A, rather than as a conclusion to be transcribed, is the only defensible workflow.

4. Practical recommendations

1. Cultivate an Australian-rules-first habit: make the determination independently under the 8 items of Schedule 2A first, then compare against the European conclusion for differences, and never apply a default mapping in either direction.
2. For companion diagnostic programmes, budget fees and audit probability at the Class 3 tier from project initiation, and plan the ARTG entries split by UPI so that the register structure matches the statutory kind requirements.
3. For in-house IVD programmes, assess readiness against ISO 15189 and the NPAAC requirements separately from routine laboratory work, and reserve a communication window for the Secretary-led assessment of the quality management system.
4. For self-testing IVDs, beyond classification, prepare the technical documentation required for assessment under the mandatory application audit route (see articles 24 and 25 for details), since the self-testing trigger and the documentation trigger are separate legal tests.

5. Verification checklist

• □ The class has been determined independently under Schedule 2A items 1.1–1.8
• □ Whether the device falls under companion diagnostics (cl 1.3(fa)) or self-testing (cl 1.4) has been confirmed
• □ If an in-house IVD, the application of Schedule 3 Part 6B and the Secretary assessment has been confirmed
• □ Readiness against ISO 15189 and the NPAAC requirements has been checked
• □ The final conclusion has been issued under the Australian rules rather than a European mapping table

Regulatory information verified as of 29 October 2026.

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 manages TGA inclusion and ARTG listing applications, coordinates conformity assessment evidence, and supports post-market vigilance obligations. Business enquiries: info@grzan.cn