TGA Officially Releases 2026–27 Financial Year Fee Schedule
The Australian Therapeutic Goods Administration (TGA) officially released its fee schedule for the 2026–27 financial year on July 1, 2026. The new fee schedule applies from July 1, 2026 to June 30, 2027, in line with Australia’s financial year, which begins on July 1 each year.
Overall, TGA fees for various regulatory services continue their annual upward trend. The detailed fee changes for medical devices and in vitro diagnostic devices (IVDs) compared with the 2025–26 financial year are outlined below.
1. Medical Devices
★ Annual Fees
For the 2026–27 financial year, the annual fee for Class III medical devices and AIMDs is AUD 1,662, while the annual fee for Class I – Other devices remains relatively low at AUD 121.
| Product Category | AUD per Item (2026–27) | AUD per Item (2025–26) |
|---|---|---|
| AIMD | 1,662 | 1,566 |
| Class III | 1,662 | 1,566 |
| Class IIb | 1,305 | 1,230 |
| Class IIa | 1,305 | 1,230 |
| Class I – Sterile | 879 | 828 |
| Class I – Measuring | 879 | 828 |
| Class I – Other | 121 | 114 |
★ Application Fees
The application fee for Class III medical devices is AUD 1,603, while the fee for Class IIb and Class IIa devices is AUD 1,244. The application fee for Class I – Sterile and Class I – Measuring devices is AUD 651.
| Product Category | AUD per Item (2026–27) | AUD per Item (2025–26) |
|---|---|---|
| Class III | 1,603 | 1,530 |
| Class IIb | 1,244 | 1,187 |
| Class IIa | 1,244 | 1,187 |
| Class I – Sterile | 651 | 621 |
| Class I – Measuring | 651 | 621 |
| Class I – Other (excluding devices for export only) | 651 | 621 |
2. In Vitro Diagnostic Devices (IVDs)
★ Annual Fees
For IVDs, the annual fee is uniformly AUD 948 per item, except for Class 4 in-house IVDs, for which no annual fee is listed.
| Product Category | AUD per Item (2026–27) | AUD per Item (2025–26) |
|---|---|---|
| All classes of IVDs (excluding Class 4 in-house IVDs) | 948 | 893 |
| Class 4 in-house IVDs | N/A | N/A |
★ Application Fees
The application fee for including all classes of IVDs in the Australian Register of Therapeutic Goods (ARTG) is AUD 1,244 per item, including Class 4 in-house IVDs, except for IVDs intended for export only.
| Product Category | AUD per Item (2026–27) | AUD per Item (2025–26) |
|---|---|---|
| Applications to include all classes of IVDs in the Australian Register of Therapeutic Goods (ARTG), including Class 4 in-house IVDs (excluding IVDs for export only) | 1,244 | 1,187 |
◆ Compliance Tips
Budget Planning
Medical device and IVD manufacturers should review and adjust their 2026–27 regulatory registration budgets in accordance with the updated TGA fee schedule.
Submission Timing
For companies currently preparing applications for new ARTG inclusions or regulatory changes, it is advisable to carefully consider the submission schedule and applicable fee rates when planning submissions around the financial year transition.
Advantage for Class I – Other Devices
The annual fee for Class I – Other medical devices remains relatively low at AUD 121 per item. For companies primarily marketing Class I – Other devices in Australia, the ongoing regulatory cost remains comparatively manageable.
The release of the 2026–27 TGA fee schedule means that companies planning to enter or expand in the Australian medical device and IVD markets should incorporate the updated regulatory fees into their market access and compliance budgets.
For manufacturers preparing ARTG applications, variations, or other regulatory submissions, understanding the latest TGA fee requirements in advance can help improve budget planning and submission efficiency.