TGA Medical Device and IVD Fees & Annual Charges 2026
Starting 1 July 2026, Australia's TGA has updated fees and annual charges for medical devices and IVDs, including ARTG application assessments, audit fees, annual charges, and Annual Charge Exemption deadlines. Manufacturers and Australian Sponsors should review portfolio status and payment timelines to avoid unnecessary costs or ARTG disruption.
The TGA Medical Device and IVD Fees & Annual Charges 2026 give manufacturers and Australian Sponsors an updated view of the regulatory costs associated with obtaining and maintaining market access in Australia. Effective 1 July 2026, the updated schedule covers application assessment fees, audit fees, and annual Australian Register of Therapeutic Goods (ARTG) charges for medical devices and in vitro diagnostic (IVD) medical devices.
Understanding both application fees and ongoing annual charges is important for budgeting, maintaining compliance, and avoiding unnecessary regulatory costs.
What the TGA fees and charges summary covers
The Therapeutic Goods Administration (TGA) operates under the Therapeutic Goods Act 1989 and recovers the cost of regulating therapeutic goods through:
- Application assessment fees
- Conformity assessment fees
- Audit fees
- Annual ARTG charges
These costs support product evaluations, market authorization, post-market surveillance, and ongoing regulatory oversight.
TGA medical device and IVD fees from 1 July 2026
Medical devices
| Fee type | Applicable class | Fee (AUD) |
|---|---|---|
| ARTG Annual Charge | Class I (Other) | $121 |
| ARTG Annual Charge | Class I (Measuring/Sterile) | $879 |
| ARTG Annual Charge | Class IIa & IIb | $1,305 |
| ARTG Annual Charge | Class III & AIMD | $1,662 |
| Application Assessment Fee | Class I | $651 |
| Application Assessment Fee | Class IIa & IIb | $1,244 |
| Application Assessment Fee | Class III | $1,603 |
| Application Audit Fee | Level 1 | $4,926 |
| Application Audit Fee | Level 2 | $18,118 |
IVD medical devices
| Fee type | Applicable class | Fee (AUD) |
|---|---|---|
| ARTG Annual Charge | Class 1-4 | $948 |
| Application Assessment Fee | Class 1-4 | $1,244 |
| Application Audit Fee | Class 1-2 | $8,364 |
| Application Audit Fee | Class 3-4 | $16,077-$25,350 |
Understanding TGA annual charges
Application fees are only one part of the regulatory cost of marketing medical devices and IVDs in Australia.
The TGA also applies annual charges to most devices that remain included in the ARTG on 1 July each year. These annual charges fund ongoing regulatory activities such as:
- Post-market surveillance
- Compliance monitoring
- Safety investigations
- Regulatory oversight throughout the product lifecycle
Unlike application fees, annual charges continue for as long as a product remains included in the ARTG.
Why manufacturers should review their ARTG portfolio
The beginning of each financial year is an important time for manufacturers and Australian Sponsors to review their ARTG portfolio.
Consider whether:
- All ARTG entries are still commercially active.
- Any products have been discontinued or withdrawn from the Australian market.
- Sponsor, manufacturer, and product information remains up to date.
- Existing ARTG entries require lifecycle changes or administrative updates.
Regular portfolio reviews can reduce unnecessary annual charges while supporting ongoing regulatory compliance.
Key TGA annual charge timeline
Manufacturers should work closely with their Australian Sponsor to ensure all annual charge obligations are met.
| Timeline | Activity |
|---|---|
| 1 July | Annual charges apply to eligible ARTG entries remaining active. |
| 1-22 July | Sponsors may submit a $0 Turnover Declaration for eligible products under the Annual Charge Exemption (ACE) Scheme. |
| 23 July-15 September | Late declarations may be accepted with an administration fee. |
| 1-15 August | TGA issues annual charge invoices. |
| 15 September | Payment due date for annual charges. |
| December | The TGA may commence cancellation or other regulatory action for unpaid annual charges. |
Understanding these milestones helps manufacturers coordinate payment activities with their Australian Sponsor and avoid disruptions to market access.
Annual Charge Exemption (ACE) Scheme
Some ARTG entries may qualify for the Annual Charge Exemption (ACE) Scheme if they recorded no turnover during the relevant financial year.
To benefit from the exemption:
- The ARTG entry must meet the eligibility requirements.
- A $0 Turnover Declaration must be submitted within the TGA's specified timeframe.
- Manufacturers should discuss eligibility with their Australian Sponsor well before the declaration deadline.
Missing the declaration period may result in annual charges becoming payable or additional administrative fees.
Planning for ongoing compliance
Application fees and annual ARTG charges are important components of maintaining medical device and IVD registrations in Australia. Manufacturers should incorporate these regulatory costs into annual planning and work closely with their Australian Sponsor to manage fee payments, portfolio reviews, and regulatory obligations.
In addition to budgeting for application assessments and audits, manufacturers should regularly review their ARTG portfolio to identify inactive products, confirm that sponsor and product information is current, and determine whether lifecycle updates or administrative changes are required. Proactive portfolio management can help minimize unnecessary regulatory costs while supporting continued compliance with TGA requirements.
Conclusion
The TGA Medical Device and IVD Fees & Annual Charges 2026 introduce the latest application fees, audit fees, and annual ARTG charges effective from 1 July 2026. Manufacturers and Australian Sponsors should review the updated fee schedule alongside their ARTG portfolio and annual compliance obligations to support accurate budgeting and uninterrupted market access. As the published schedule is a summary, applicants should refer to official TGA legislation and guidance to confirm the fees and requirements applicable to their submissions.
Internal links
- TGA Australia Medical Device Registration & Approval
- How to register medical devices and IVDs in Australia
External links
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