TGA current fee schedule, reviewed for 2026, in AUD.
11 fee lines100% exact amountscurrency AUDFX rates 2026-11-09reviewed 2026-08-25
| Fee line | Official amount | USD equivalent | Frequency | Provenance |
|---|---|---|---|---|
| Annual Charge - Class I (other) | AUD 121 | $83.12 | Annual per ARTG entry | Verified |
| Annual Charge - Class I (measuring/sterile) | AUD 879 | $604 | Annual per ARTG entry | Verified |
| Annual Charge - Class IIa/IIb | AUD 1,305 | $896 | Annual per ARTG entry | Verified |
| Annual Charge - Class III/AIMD | AUD 1,662 | $1,142 | Annual per ARTG entry | Verified |
| Application Fee - Class I | AUD 651 | $447 | Per ARTG inclusion application | Verified |
| Application Fee - Class IIa/IIb | AUD 1,244 | $855 | Per ARTG inclusion application | Verified |
| Application Fee - Class III | AUD 1,603 | $1,101 | Per ARTG inclusion application | Verified |
| IVD Annual Charge | AUD 948 | $651 | Annual per ARTG entry | Verified |
| IVD Application Fee | AUD 1,244 | $855 | Per ARTG inclusion application | Verified |
| UDI Consent to Supply application - first ARTG entry | AUD 80 | $54.95 | Per application | Verified |
| UDI Consent to Supply - each additional ARTG entry in the same application | AUD 10 | $6.87 | Per additional entry | Verified |
Government fees only — service and testing costs are separate- Annual charges apply each financial year per ARTG entry
- Application fees apply per ARTG inclusion application
- Different fees for Class I subtypes
- ARTG variation application fees follow Schedule 9, Part 2 Item 2A of the Therapeutic Goods Regulations 1990; notification of a change of sponsorship carries no fee.
- Annual charges apply to every ARTG entry: invoices issue each July for non-ACE entries, non-payment within 20 working days is a ground for cancellation (s 41GL(f)) or suspension (s 41GA(1)(b)), and the Annual Charge Exemption applies until turnover commences. Current-year amounts sit in TGA’s downloadable fees and charges summaries.
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Exact amounts verified against the TGA fee schedule · full review 2026-08-25 · row IDs are stable — cite as government-fees:australia:annual-charge-class-i-other