Comparison of Australian TGA Fees and Annual Charges for Medical Devices and IVDs (2025 vs. 2026)
Note: All monetary figures are quoted in Australian Dollars (AUD). Fees for 2025 and 2026 take effect on July 1 of their respective financial years.
| Category / Fee Description | 2025 Fee | 2026 Fee | Fee Adjustment (AUD / %) |
| Medical Device Annual Charges | |||
| • AIMD / Class III | $1,566 | $1,662 | + $96 (+6.13%) |
| • Class IIb / Class IIa | $1,230 | $1,305 | + $75 (+6.09%) |
| • Class I - Sterile / Measuring | $828 | $879 | + $51 (+6.15%) |
| • Class I - Other | $114 | $121 | + $7 (+6.14%) |
| Medical Device Application Fees | |||
| • AIMD/Class III | $1,530 | $1,603 | + $73 (+4.77%) |
| • Class IIb / Class IIa | $1,187 | $1,244 | + $57 (+4.80%) |
| • Class I (Sterile / Measuring / Other) | $621 | $651 | + $30 (+4.83%) |
| In Vitro Diagnostic (IVD) Fees | |||
| • IVD Annual Charge (Excl. Class 4 In-house IVD) | $893 | $948 | + $55 (+6.15%) |
| • IVD ARTG Inclusion Application Fee (All Classes) | $1,187 | $1,244 | + $57 (+4.80%) |
| Application Audit Assessment Fees | |||
| • Level 1 Application Audit | $4,700 | $4,926 | + $226 (+4.81%) |
| • Level 2 Application Audit (Class III) | $17,288 | $18,118 | + $830 (+4.80%) |
| • IVD Class 1 & Class 2 Audit Assessment | $7,981 | $8,364 | + $383 (+4.80%) |
| • IVD Class 3 (other than Class 3 IVDs to which item 1.14AA applies) & Class 4 other than: (i) Class 4 IVDs that are immunohaematology reagent IVD medical devices; or (ii) devices to which item 1.14B or 1.14C applies Audit Assessment |
$24,189 | $25,350 | + $1,161 (+4.80%) |
| • Class 4 IVDs that are immunohaematology reagent IVD medical devices | 17,959 | 18,821 | + $862 (+4.79%) |
| • Class 3 IVD medical devices or Class 4 IVD medical devices (other than devices to which paragraph (d) of item 1.14A, or item 1.14C, applies), where the devices are not subject to laboratory testing as part of the auditing of the application | 15,341 | 16,077 | + $736 (+4.79%) |
| • Class 4 in house IVD medical devices (other than a device to which item 1.14C applies) | 24,189 | 25,350 | + $1,161 (+4.79%) |
| Conformity Assessment & Other Fees | |||
| • Conformity Assessment Application Fee | $1,530 | $1,603 | + $73 (+4.77%) |
| • Full quality management system assessment Fee | $34,589 | $36,249 | + $1660 (+4.79%) |
| • Design examination assessment Fee | $61,842 | $64,810 | + $2,968 (+4.79%) |
| • Type examination assessment Fee | $47,337 | $49,609 | + $2,272 (+4.79%) |
| • Verification assessment Fee | $33,147 | $34,738 | + $1,591 (+4.79%) |
| • Production quality management system assessment Fee | $30,264 | $31,717 | + $1,453 (+4.80%) |
| • Product quality management system assessment Fee | $25,831 | $27,071 | + $1,240 (+4.80%) |
Executive Summary & Fee Trend Analysis
Starting July 1, 2026, the Australian Therapeutic Goods Administration (TGA) will implement an overall increase in regulatory fees and annual charges for medical devices and in vitro diagnostic (IVD) devices. Key insights from the comparative analysis include:
- Annual Charges: Annual maintenance charges across all medical device and IVD risk classes demonstrate an upward adjustment of approximately 6.1% to 6.3%. Higher-risk categories incur higher baseline costs, resulting in larger absolute monetary increases.
- Application & Audit Fees: Application fees for inclusion on the ARTG, as well as mandatory application audit assessment fees, consistently show a uniform increase of roughly 4.7% to 4.8%.
- Budgetary Impact: High-risk medical devices (Class III / AIMD) and high-risk IVDs (Class 3 / Class 4) experience the largest cost impact. Medical device sponsors and manufacturers are advised to factor in these increased operational and regulatory assessment budgets well in advance of upcoming submissions.
Strategic Insights from QT
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Insight 1: Leveraging Overseas Approvals to Offset Inflationary Costs
While baseline entry costs and annual charges for the Australian market will rise with inflation starting in the 2026 financial year, overall regulatory budgets do not necessarily have to increase. Through close monitoring and collaboration with our local regulatory experts in Australia, we have observed that the TGA is actively optimizing its review processes. If your product already holds certifications from major comparable markets, such as CE marking or FDA clearance, Qualtech can strategically evaluate the feasibility of utilizing the "Abridged Assessment" or Comparable Overseas Regulator (COR) pathways. This approach not only accelerates market access but the substantial reduction in actual assessment fees often completely offsets, or even exceeds, the standard annual fee increases.
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Insight 2: A Long-Term Perspective on Budgeting: Managing Hidden Costs
In this latest fee adjustment, high-risk medical devices (Class III / AIMD) and high-risk IVDs (Class 3 / Class 4) face the most significant absolute financial impact due to their higher baseline costs. Medical device manufacturers and local Sponsors should look beyond the initial ARTG application fees. It is crucial to factor these escalating annual maintenance charges into long-term operational budgets and distributor agreements well in advance. Proactive financial planning will prevent future profit margins from being eroded by ongoing regulatory compliance costs.
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Insight 3: Qualtech – Your Strategic Regulatory and Financial Partner
In today's rapidly evolving global regulatory landscape, choosing the optimal registration pathway is more strategic than ever. Qualtech's core value lies in conducting a comprehensive dual assessment of both your regulatory roadmap and the associated financial investment. We do more than just monitor TGA fee schedules; we proactively identify cost-saving opportunities generated by regulatory reforms, ensuring that every dollar of your market access budget is maximized for the highest return on investment.
Call-To-Action
Understanding a new market often requires both local knowledge and regional experience. With our local offices in Australia & New Zealand and 26+ years of experience across Asia Pacific, Qualtech supports medical device companies in navigating market regulatory requirements and evaluating growth opportunities. Contact us to discuss your plans for the ANZ region.
Reference
Australian Therapeutic Goods Administration (TGA) Schedule of Fees and Charges (2025-2026)