ARTG Entry Consolidation and Fee Cost Optimisation

1. Key takeaways

Placing multiple models under a single ARTG entry works in Australia only for low and medium risk devices. Section 41BE(1) of the Therapeutic Goods Act 1989 requires the same sponsor, the same manufacturer, the same GMDN code and the same classification; but regulation 1.6 of the device regulations adds the unique product identification (UPI) as an element of the kind for Class III devices, AIMDs, Class 4 IVDs (other than immunohaematology reagents) and IVD companion diagnostics — for these categories each model effectively needs its own entry.

• Consolidation is lawful only when all five kind elements align.
• UPI rules force one entry per model for the high-risk categories.
• All inclusion fees, annual charges and variation fees are charged per entry.
• No small-enterprise fee relief exists; concessions follow entries and turnover, not size.
• Australian concessions follow entries and turnover, not enterprise size.

The structure rewards planning at the classification and coding stage and punishes retro-fitting. Once entries exist, every correction runs through the variation fee schedule, so the cheapest moment to fix the entry map is before the first application is lodged.

2. Legal basis

The provisions below cover the kind test, the UPI carve-out, the per-entry fee structure and the reduction mechanisms, ending with a practical estimate on terminology and reliefs.

1. Therapeutic Goods Act 1989 (Act No. 21, 1990): the same-kind test appears in section 41BE(1)(a)–(e) — the same sponsor, the same manufacturer, the same GMDN code, the same classification, and other characteristics prescribed by the regulations.
2. Therapeutic Goods (Medical Devices) Regulations 2002 (F2002B00237, compilation F2026C00883): regulation 1.6 — for Class III devices, AIMDs, Class 4 IVDs (other than immunohaematology reagents) and IVD companion diagnostics, the “other characteristics” element is the UPI.
3. Fees are charged per entry: inclusion application fees per Schedule 5 (Class III AUD 1,603; Class IIa / IIb AUD 1,244; Class I AUD 651; IVDs of all classes AUD 1,244); annual charges per Therapeutic Goods (Charges) Regulations 2018, regulation 7(4) (Class I other AUD 121; Class IIa / IIb AUD 1,305; Class III / AIMD AUD 1,662; IVDs AUD 948).
4. Variation fees: Therapeutic Goods Regulations 1990, Schedule 9 Part 2 — non-IVD devices AUD 1,133, or AUD 215 per 10 entries (2A(g)).
5. Reduction mechanisms: regulation 9.6 (public interest reductions of 70%), regulations 9.7 and 9.1C (simplified assessment), regulation 9.1AA (UDI and European Union transition related), regulation 9.9 and Part 8A; general authorisation in Therapeutic Goods Act 1989, section 63(3)(b).
6. ACE annual charge exemption: section 44A and Therapeutic Goods Regulations 1990, sections 43AAA–43AAGF.
7. [practical estimate] No fee reduction provision specifically for “small enterprises” was found; Australia grants concessions by entry and turnover rather than by enterprise size. In addition, the term “generic device group” was not found in the Therapeutic Goods Act 1989 or the regulations; the corresponding Australian concept is “kind of medical device”.

3. Expert insights

Insight 1: misjudging the consolidation rules hits compliance and cost at the same time. Failing to split high-risk categories that must be split breaches the kind test (a compliance risk); failing to consolidate low and medium risk devices that could be consolidated means paying unnecessary application fees and annual charges (a cost waste). Because fees are charged per entry, the number of entries directly determines long-term cost. A consolidation review before inclusion costs nothing but analysis; the same review after inclusion costs variation fees, and a wrong consolidation that must be unwound costs them twice.

Insight 2: the GMDN code is a hard constraint on consolidation. Section 41BE(1) requires the same GMDN code. Models within the same product line that carry different GMDN codes cannot be consolidated even where their functions are close. Decisions made at the code selection stage shape the entry structure for years. It is worth recording the code rationale for each model at selection time, because the justification that supported consolidation must be reproduced whenever TGA queries the entry structure.

Insight 3: changing the sponsor means changing the kind. The sponsor is one of the constituent elements of the kind. Switching the holding model therefore triggers variations for every entry (section 10F), and the consolidation strategy must be executed again from the start. Companies contemplating a change of holding model should therefore cost the re-consolidation effort into the decision, not only the transfer fee itself.

In sum, cost optimisation in Australia is entry architecture. The levers are all structural: how many entries exist, how models are grouped under the kind test, how batch variations are priced, and how the reduction provisions are invoked. None of these levers involves a discount negotiation; they involve decisions taken before and during inclusion, executed against the letter of section 41BE(1) and regulation 1.6, and revisited annually as the portfolio grows.

4. Practical recommendations

• Plan the entry structure at the GMDN code selection stage, aligning “models intended for future consolidation” under the same code.
• Tier the strategy by risk: consolidate as much as possible for low and medium risk devices; split by UPI for high-risk categories and accept the corresponding fee structure.
• Use the “AUD 215 per 10 entries” variation fee tier for batch changes to dilute the per-change cost.
• Assess the applicability of the ACE exemption and the public interest reduction (70%), citing the specific provision numbers in the application.

5. Verification checklist

• □ The entry structure has been planned against the five elements of section 41BE(1)
• □ High-risk categories have been split under the regulation 1.6 UPI rule
• □ GMDN codes were aligned at the code selection stage
• □ The cost dilution of batch variations has been assessed
• □ Applicability of the ACE exemption and the section 9.6 reduction has been assessed

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 coordinates Australian sponsor arrangements, ARTG annual charges, and supports post-market vigilance obligations. Business enquiries: info@grzanglobal.com