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Fees & Charges

Overview​

The TGA charges fees for ARTG inclusion applications and annual charges for maintaining ARTG entries. Fees are updated annually (typically from 1 July each financial year) and are set out in Schedule 5 of the Therapeutic Goods (Medical Devices) Regulations 2002 and the Therapeutic Goods (Charges) Act 1989. Always verify the current fee schedule on the TGA website before submitting an application, as fees change each year.

Types of Charges​

Application fees Charged when an application for ARTG inclusion is submitted. Application fees are not refunded if the application fails preliminary assessment, is withdrawn, or is rejected at audit. The fee reflects the level of regulatory work required and varies by device class.

Application audit assessment fees Charged when an application is subject to a mandatory audit (under Regulation 5.3). No audit assessment fee is charged for non-mandatory (risk-based) audits. The audit assessment fee is payable in addition to the application fee.

Annual charges Charged annually for each ARTG entry that remains active. Annual charges are the mechanism by which the TGA recovers the costs of ongoing regulatory oversight (post-market surveillance, monitoring, administration). Failure to pay annual charges can result in cancellation of the ARTG entry.

Conformity assessment fees Separate fees apply if the manufacturer applies for TGA-issued Conformity Assessment Certification. These are charged based on the scope and extent of assessment conducted.

Current Fee Schedule​

Fees are published in the TGA's annual fees and charges summary document, updated each July. For current fees, always refer to the official TGA source:

👉 Fees and charges summary — TGA

👉 Schedule 5 — Fees (MD Regulations)

Fee Reductions​

Export-only devices Application fees for devices intended for export only (not supplied in Australia) are generally lower than for devices supplied in Australia.

Small business/SME concessions The TGA offers certain fee concessions for small businesses. Check the TGA SME Assist service for current eligibility criteria:

👉 SME Assist — TGA

Abridged assessment Where a manufacturer applies for TGA conformity assessment certification and submits overseas audit reports to support abridgement, the TGA may reduce the assessment fees if a full on-site audit is not required.

Annual Charges — Key Points​

  • Annual charges are levied on the sponsor for each active ARTG entry
  • Charges apply regardless of whether the device is actively being supplied
  • Annual charges differ by device class (higher-risk classes attract higher annual charges)
  • Failure to pay results in cancellation of the ARTG entry — which means the device can no longer be legally supplied
  • Sponsors can cancel ARTG entries they no longer need to avoid ongoing annual charge obligations

Official Sources​