TGA Fee Schedule 2026-27 for Medical Devices and IVDs

1. Key takeaways

TGA fees are adjusted on 1 July each year. The current basis for the 2026–27 financial year is the TGA document Fees and charges: Summary, From 01 July 2026 (Version 1.0, July 2026), with amounts expressed in Australian dollars (AUD). Using a Class III device as an example: the inclusion application fee is AUD 1,603, the annual charge is AUD 1,662, and if a Level 2 application audit is triggered a further AUD 18,118 applies.

• All amounts below are stated for the 2026–27 financial year in AUD.
• Annual charges scale by device class, from AUD 121 to AUD 1,662 per entry.
• The Level 2 audit fee for Class III devices exceeds eleven times the inclusion application fee.
• The UDI-specific consent fee has been reduced to AUD 80 plus AUD 10 for each additional entry for 2026–27.
• Variation fees range from AUD 215 per 10 entries to AUD 1,982 for Class 3 / 4 IVDs.

Because the fee document is reissued every 1 July, every amount in this article is a snapshot for one financial year only, and any budget that spans a year boundary must be re-quoted against the next issue.

The same discipline applies to item numbers: the schedule cites item numbers such as 1.5, 1.13, 1.14, 1.15 and 1.17, and those numbers, unlike the amounts, are stable across years. Budget models should therefore key on the item numbers and pull amounts from the current-year document rather than hard-coding figures that silently expire on 30 June.

2. Legal basis

The amounts below are taken from the TGA fee document for 2026–27 and from the regulations cited for each fee type. Amounts not confirmed in this verification round are flagged as a practical estimate.

1. Fee document: TGA, Fees and charges: Summary, From 01 July 2026, Version 1.0, published July 2026; currency is the Australian dollar; effective from 1 July 2026, adjusted on the same day each year.
2. Annual charges (Therapeutic Goods (Charges) Regulations 2018, regulation 7(4)): Class I, other — AUD 121 (7(4)(a)); Class I, sterile or measuring — AUD 879 (7(4)(b)); Class IIa / IIb — AUD 1,305 (7(4)(c)); Class III / AIMD — AUD 1,662 (7(4)(d)); IVDs of all classes (excluding Class 4 self-test) — AUD 948 (7(4)(e)); Class 4 self-test IVDs — not applicable (7(4)(f)).
3. Inclusion application fees (Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 5 Part 1): Class III — AUD 1,603 (item 1.5(b)); Class IIb — AUD 1,244 (1.5(c)); Class IIa — AUD 1,244 (1.5(d)); Class I, sterile or measuring — AUD 651 (1.5(e)); Class I, other — AUD 651 (1.5(g)); IVDs of all classes — AUD 1,244; priority applicant decision — AUD 12,591 (item 1.5A).
4. Application audit fees (Schedule 5): Level 1 — AUD 4,926 (item 1.13); Level 2 (Class III, non-IVD) — AUD 18,118 (1.14(a)); IVD Class 1 / 2 — AUD 8,364; IVD Class 3 / 4 — AUD 16,077–25,350.
5. Variation fees (Therapeutic Goods Regulations 1990, Schedule 9 Part 2): non-IVD devices — AUD 1,133 (2A(f)), or AUD 215 per 10 entries (2A(g)); Class 3 / 4 IVDs — AUD 1,982 (2A(d)); other IVDs — AUD 1,133 (2A(e)).
6. Other fees: laboratory notification fee for Class 1–3 in-house IVDs — AUD 1,308 (item 1.17); consent to supply where the essential principles are not met — AUD 583 for the first entry plus AUD 117 for each additional entry (item 1.15); for 2026–27 the UDI-specific consent fee is reduced to AUD 80 plus AUD 10 for each additional entry (TGA, Cost Recovery Implementation Statement 2026-27, June 2026).
7. [practical estimate] The amount for Level 2 (other devices) at item 1.14(b), the export-only application fee, the sponsor transfer fee and the late declaration fee were not found in official sources during this verification round.

3. Expert insights

Insight 1: the audit fee is the largest cost variable. The Level 2 audit fee for Class III devices, AUD 18,118, is more than eleven times the inclusion application fee of AUD 1,603. Whether the project falls into mandatory audit (regulation 5.3(1)) and whether an exemption can be obtained (regulation 5.3(2AA)) directly determines the order of magnitude of project cost.

Insight 2: annual charges are per entry, not per enterprise. Annual charge tiers are tied only to device classification, ranging from AUD 121 to AUD 1,662. For companies with many entries, the total annual charge grows linearly with the number of entries, which makes entry consolidation an important cost lever (see article 40).

Insight 3: the UDI consent fee has been reduced to a very low level on purpose. For 2026–27 the UDI-specific consent is AUD 80 plus AUD 10 per additional entry, far below the regular consent of AUD 583 plus AUD 117. This is a policy channel designed by TGA for the UDI transition; companies should evaluate it first rather than absorbing compliance failure (see article 45).

4. Practical recommendations

• Model the budget as the sum of application fee, possible audit fee and first-year annual charge, and reserve for Class III projects on the worst-case assumption including a Level 2 audit.
• When citing amounts, annotate the financial year and the document name (2026–27, Fees and charges: Summary, From 01 July 2026) to avoid cross-year misuse.
• Update the internal fee schedule on 1 July each year and reconcile the budgets of scheduled projects at the same time.
• For projects unable to meet UDI requirements on time, evaluate the UDI-specific consent channel first (from AUD 80).

5. Verification checklist

• □ The budget models application fee, audit fee and annual charge as three items
• □ Class III projects reserve for the worst case including a Level 2 audit
• □ Cited amounts are annotated with the 2026–27 financial year and document name
• □ A fee schedule update milestone is set for 1 July
• □ UDI non-compliant projects have been assessed for the consent channel from AUD 80

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