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Australia Medical Device Registration Fees
TGA government fees for 2025
AUD 114
Low Risk Min
AUD 1,566
High Risk Max
TGA
Authority
2025-09-17
Last Updated
Australia (TGA) Fee Overview
Australia (TGA) operates a risk-based fee structure with application fees plus ongoing annual charges. Application fees range from AUD 1,290 (~$850) for low-risk to AUD 30,000+ (~$20,000) for high-risk devices. The TGA accepts CE marking and FDA clearance through conformity assessment pathways, which can reduce both fees and timelines.
Complete Fee Breakdown
| Fee Item | Amount | Frequency |
|---|---|---|
Annual Fee - Class I (other) | AUD 114 | Annual per product |
Annual Fee - Class I (measuring/sterile) | AUD 828 | Annual per product |
Annual Fee - Class IIa/IIb | AUD 1,230 | Annual per product |
Annual Fee - Class III/AIMD | AUD 1,566 | Annual per product |
Application Fee - Class I | AUD 621 | One-time per product |
Application Fee - Class IIa/IIb | AUD 1,187 | One-time per product |
Application Fee - Class III | AUD 1,530 | One-time per product |
IVD Annual Fee | AUD 893 | Annual per product |
IVD Application Fee | AUD 1,187 | One-time per product |
Key Facts About TGA Fees
- 1Class I: AUD 1,290 application + annual charges
- 2Class IIa/IIb: AUD 3,000-8,000+ per application
- 3Class III: AUD 15,000-30,000+ per application
- 4Annual listing charges per device
- 5CE/FDA recognition available
Important Notes
- •Annual fees apply every year per product
- •Application fees are one-time
- •Different fees for Class I subtypes
Tips for Australia Registration
- 1Use Comparable Overseas Regulator pathways (FDA/CE)
- 2Budget for annual listing charges
- 3TGA audits for Class III manufacturers
Frequently Asked Questions
Related Resources
Government fees are subject to change. Last data update: 2025-09-17. Always verify current fees with TGA.