TGA Fee Structure and Legal Authority for Charges

1. Key takeaways

TGA’s three fee categories rest on different legal authorities: the annual charge (a “charge”, which has a tax-like character) is imposed under section 4(1B) of the Therapeutic Goods (Charges) Act 1989; application fees and assessment fees rest on Part 4-10 of the Therapeutic Goods Act 1989 (sections 41LA–41LE) together with regulation 9.1 and Schedule 5 of the Therapeutic Goods (Medical Devices) Regulations 2002. The three categories differ in how often they adjust and in the reduction mechanisms available.

• The annual charge is a charge under the Charges Act, recoverable as a Commonwealth debt.
• Application and assessment fees rest on Part 4-10 of the Act and Schedule 5 of the device regulations.
• The 28 days payment window for audit fees is a hard constraint that can lapse the application.
• Reduction mechanisms are scattered across several provisions and must be cited by number.
• Refund and waiver powers also sit in regulation 9.9 and Part 8A.

Reading the three categories separately also explains why invoices arrive at different rhythms: application fees arise once per inclusion event, assessment fees arise only when an audit is selected, and annual charges recur every year for every entry, which is where the long-term budget weight actually sits.

2. Legal basis

Each fee category below is traced to its authorising statute or regulation, including the reduction and refund authorities. Because the authorities are split across two statutes and two regulations, each amount below is annotated with the exact instrument it comes from.

1. Therapeutic Goods (Charges) Act 1989 (Therapeutic Goods (Charges) Act 1989, No. 22, 1990, compilation C2004A03953): section 4(1B) — imposition of an annual charge on the inclusion of medical devices in the ARTG; section 5 — authorises the regulations to prescribe amounts.
2. Therapeutic Goods (Charges) Regulations 2018 (compilation F2018L00774): regulation 7(4) prescribes the annual charge amounts.
3. Application fees and assessment fees: Part 4-10 of the Therapeutic Goods Act 1989, sections 41LA–41LE; Therapeutic Goods (Medical Devices) Regulations 2002 (F2002B00237), regulation 9.1 and Schedule 5; the due date for audit fees appears in regulation 9.2 (28 days after notice).
4. Three-category division: application fee (inclusion application fee), assessment fee (conformity assessment fee / application audit fee), and annual charge.
5. Variation fees: Therapeutic Goods Regulations 1990, Schedule 9 Part 2 (item 2A).
6. Reduction and refund authorities: Therapeutic Goods Act 1989, section 63(3)(b); regulation 9.6 (public interest reductions of up to 70%), regulations 9.7 and 9.1C (reductions where the assessment can be simplified), regulation 9.1AA (consent fee reductions relating to UDI and the European Union transition), and regulation 9.9 with Part 8A (specific refunds and waivers).

3. Expert insights

Insight 1: the annual charge is a charge, not a fee — the legal character differs. The annual charge is authorised by a separate charges statute and is a tax-like imposition; application fees and assessment fees are authorised by the Therapeutic Goods Act. This distinction determines the recovery route — overdue annual charges can be recovered as a debt due to the Commonwealth (see article 38). It also explains why the annual charge cannot be negotiated away or offset against other fees, while application and assessment fees sit inside a remission framework that the Secretary can apply case by case.

Insight 2: the 28 days window for audit fees is a hard constraint. Regulation 9.2 requires the audit fee to be paid within 28 days of notice. Non-payment does not merely attract a late surcharge; it triggers the lapse provisions for the application (section 41FK of the Therapeutic Goods Act 1989). The lapse is silent from the applicant’s point of view: no hearing, no negotiation, just a stopped application that must be restarted, with the calendar cost far exceeding the fee itself.

Insight 3: the reduction mechanisms are scattered across multiple provisions. The public interest reduction (regulation 9.6, 70%), the simplified assessment reductions (regulations 9.7 and 9.1C) and the UDI and EU transition reductions (regulation 9.1AA) each have their own conditions. A generic request for a “fee reduction” that does not cite the specific provision is usually refused. The corollary is that reduction requests are drafting exercises: the application must name the regulation, recite its conditions and attach the evidence that those conditions are met.

A closing note on verification discipline. Because the three fee families live in different instruments that amend on different schedules, a single consolidated internal fee table is the only reliable reference point. Tables assembled from web pages of mixed vintage are the most common source of budgeting errors, and the fix is procedural rather than technical: one owner, one table, one review date.

The same discipline extends to the wording of fee types. Internal budgets that speak loosely of registration fees blur three legally distinct impositions, and that looseness surfaces exactly when it matters — in lapse situations, in debt recovery and in reduction applications, each of which turns on the precise category the money belongs to.

4. Practical recommendations

• Model costs in three categories — application fees, assessment fees (including mandatory audit scenarios) and annual charges — and annotate each with its authorising provision and adjustment rhythm.
• For projects selected for audit, start the 28 days payment countdown immediately upon receiving the notice and assign a single responsible owner.
• When assessing whether a reduction applies, check the conditions of regulations 9.6, 9.7, 9.1C and 9.1AA provision by provision and cite the provision numbers in the application.
• Review the fee schedule once a year on 1 July (see article 37).

5. Verification checklist

• □ The cost model separates application fees, assessment fees and annual charges
• □ Each category is annotated with its authorising provision (section 4(1B) / sections 41LA–41LE and Schedule 5)
• □ A 28 days payment countdown for audit fees is in place
• □ Applicability of reductions under regulations 9.6, 9.7, 9.1C and 9.1AA has been assessed provision by provision
• □ An annual fee schedule review milestone is set for 1 July

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