In October 2026, the Therapeutic Goods Administration (TGA) of Australia released the ‘2027-28 TGA Fees and Charges Proposal’, opening a public consultation on proposed fee and charge adjustments for the 2027-2028 financial year with industry and other stakeholders.
The adjustment covers TGA service fees and annual charges for medicines and medical devices. Among them, annual charges for medical devices are proposed to increase by an additional 5% on top of the routine indexation. The total increase for annual charges of Class IIa and higher medical devices is proposed to reach 7.37%, while other medical devices and in vitro diagnostic devices (IVDs) face a total proposed increase of 7.42%.
For medical device companies that have already been listed on the Australian Register of Therapeutic Goods (ARTG) and need to maintain market access, this annual charge adjustment will directly affect ongoing product maintenance costs.
1. Policy Background: Why Is the TGA Adjusting Its Fees?
The TGA regulates therapeutic goods in Australia, mainly including medicines, medical devices and biologicals.
To sustain its regulatory activities, the TGA obtains funding through service fees, annual charges and government appropriations under the Australian Government Charging Framework.
This adjustment is therefore mainly intended to respond to rising regulatory costs and to ensure the regulatory system can continue to operate.
2. Key Changes in the 2027-2028 Fee Adjustment
The proposed fee adjustment consists of two main parts:
- Routine adjustments to TGA service fees and annual charges;
- An additional 5% increase in annual charges for medical devices.
2.1 Routine Fee Adjustments
The following routine adjustments are proposed for the 2027-2028 financial year:
| Fee item | Proposed adjustment |
|---|---|
| All TGA service fees | 2.58% |
| Annual charges for medicines and biologicals | 2.46% |
| Annual charges for Class IIa and higher medical devices | 2.37% |
| Annual charges for other medical devices and IVDs | 2.42% |
| Other annual charges (e.g. manufacturing licences) | 2.49% |
Notably, the routine adjustment to medical device annual charges is not a uniform 2.58%, but varies by product category.
2.2 Additional 5% Increase in Medical Device Annual Charges
The change most relevant to medical device companies is that the TGA proposes an additional 5% increase in medical device annual charges on top of the routine adjustment.
| Medical device category | Routine adjustment | Additional adjustment | Total increase |
|---|---|---|---|
| Class IIa and higher medical devices | 2.37% | 5% | 7.37% |
| Other medical devices and IVDs | 2.42% | 5% | 7.42% |
3. Why Are Medical Device Annual Charges Rising an Additional 5%?
The TGA proposes the additional 5% mainly to recover the costs of Non-mandatory Medical Device Application Audits.
4. Proposed TGA Medical Device and IVD Fees for 2027-2028
Beyond the adjustment percentages, companies care most about how much they will actually have to pay.
Based on the current TGA fee schedule in effect from 1 July 2026, combined with the proposed 2027-2028 adjustment percentages, some medical device and IVD related fees can be estimated.
How the fees are calculated
All amounts below are in Australian dollars (AUD), rounded to the nearest whole dollar.
- Service fees are calculated with a 2.58% increase;
- Annual charges for Class IIa and higher medical devices are calculated with a 7.37% increase;
- Annual charges for other medical devices and IVDs are calculated with a 7.42% increase;
- The 2027-2028 amounts are estimates, not officially published new TGA fees.
4.1 Annual Maintenance Charges for Medical Devices
| Product category | Current fee | Increase | Estimated new fee |
|---|---|---|---|
| Active implantable medical devices (AIMD) | $1,662 | 7.37% | $1,784 |
| Class III medical devices | $1,662 | 7.37% | $1,784 |
| Class IIb medical devices | $1,305 | 7.37% | $1,401 |
| Class IIa medical devices | $1,305 | 7.37% | $1,401 |
| Class I sterile medical devices | $879 | 7.42% | $944 |
| Class I medical devices with measuring function | $879 | 7.42% | $944 |
| Other Class I medical devices | $121 | 7.42% | $130 |
| IVDs (other than Class 4 in-house IVDs) | $948 | 7.42% | $1,018 |
4.2 ARTG Application Fees for Medical Devices
| Application category | Current fee | Adjustment | Estimated new fee |
|---|---|---|---|
| Class III medical devices | $1,603 | 2.58% | $1,644 |
| Class IIb medical devices | $1,244 | 2.58% | $1,276 |
| Class IIa medical devices | $1,244 | 2.58% | $1,276 |
| Class I sterile medical devices | $651 | 2.58% | $668 |
| Class I medical devices with measuring function | $651 | 2.58% | $668 |
| Other Class I medical devices | $651 | 2.58% | $668 |
| IVDs (all classes) | $1,244 | 2.58% | $1,276 |
4.3 Medical Device Application Audit Fees
| Audit item | Current fee | Adjustment | Estimated new fee |
|---|---|---|---|
| Medical device Level 1 application audit | $4,926 | 2.58% | $5,053 |
| Level 2 application audit for Class III non-IVD medical devices | $18,118 | 2.58% | $18,585 |
| Application audit for IVD Class 1 and Class 2 | $8,364 | 2.58% | $8,580 |
| Application audit for IVD Class 3 | $25,350 | 2.58% | $26,004 |
| General application audit for IVD Class 4 | $25,350 | 2.58% | $26,004 |
| Application audit for IVD Class 4 immunohaematology reagents | $18,821 | 2.58% | $19,307 |
| Application audit for IVD Class 3/4 (without laboratory testing) | $16,077 | 2.58% | $16,492 |
| Application audit for IVD Class 4 in-house | $25,350 | 2.58% | $26,004 |
The audit fees above arise depending on the specific application and the applicable TGA audit requirements, and not all applications are subject to them.
4.4 ARTG Variation Fees for Medical Devices
| Variation item | Current fee | Adjustment | Estimated new fee |
|---|---|---|---|
| ARTG variation for disinfectants | $1,586 | 2.58% | $1,627 |
| Variation for Class 3/4 IVDs | $1,982 | 2.58% | $2,033 |
| Variation for IVDs of other classes | $1,133 | 2.58% | $1,162 |
| ARTG variation for non-IVD medical devices | $1,133 | 2.58% | $1,162 |
| Non-IVD medical device variations, per 10 variations (or part thereof) | $215 | 2.58% | $221 |
4.5 Conformity Assessment Fees for Medical Device Manufacturers
The following fees relate to the procedures for manufacturers applying for TGA conformity assessment.
| Assessment item | Current fee | Estimated new fee |
|---|---|---|
| Conformity assessment application fee | $1,603 | $1,644 |
| Full quality management system assessment (Full QMS) | $36,249 | $37,184 |
| Design examination | $64,810 | $66,482 |
| Type examination | $49,609 | $50,889 |
| Verification assessment | $34,738 | $35,634 |
| Production quality management system assessment | $31,717 | $32,535 |
| Product quality management system assessment | $27,071 | $27,769 |
4.6 Conformity Assessment Variation and Surveillance Fees for Medical Devices
| Item | Current fee | Estimated new fee |
|---|---|---|
| Full quality management system variation | $21,842 | $22,406 |
| Design examination variation | $39,118 | $40,127 |
| Type examination variation | $29,975 | $30,748 |
| Production quality management system variation | $18,821 | $19,307 |
| Product quality management system variation | $16,498 | $16,924 |
| Full quality management system surveillance audit | $10,526 | $10,798 |
| Production quality management system surveillance audit | $10,526 | $10,798 |
| Product quality management system surveillance audit | $10,526 | $10,798 |
| Design examination re-assessment | $64,363 | $66,024 |
| Type examination re-assessment | $49,609 | $50,889 |
| Supplementary assessment (per hour) | $537 | $551 |
4.7 Conformity Assessment Fees for IVD Manufacturers
| IVD assessment item | Current fee | Estimated new fee |
|---|---|---|
| Conformity assessment application fee | $1,603 | $1,644 |
| Full quality management system assessment | $36,365 | $37,303 |
| Design examination | $70,518 | $72,337 |
| Design examination for immunohaematology reagents | $18,821 | $19,307 |
| Type examination | $50,074 | $51,366 |
| Production quality management system assessment | $31,949 | $32,773 |
| Full quality management system re-assessment | $36,365 | $37,303 |
| Design examination re-assessment | $77,492 | $79,491 |
| Type examination re-assessment | $50,074 | $51,366 |
| Full quality management system variation | $21,819 | $22,382 |
| Design examination variation | $42,311 | $43,403 |
| Design examination variation for immunohaematology reagents | $11,293 | $11,584 |
| Abbreviated design examination for notified IVDs | $2,739 | $2,810 |
| Type examination variation | $30,045 | $30,820 |
| Production quality management system variation | $19,170 | $19,665 |
| IVD surveillance assessment | $10,584 | $10,857 |
| Supplementary assessment (per hour) | $537 | $551 |
| Notification fee for Class 1/2/3 in-house IVD laboratories | $1,308 | $1,342 |
4.8 Other Medical Device Related Fees
| Item | Current fee | Adjustment | Estimated new fee |
|---|---|---|---|
| Certificate of Freedom to Sell (CFS) for medical devices | $221 | 2.58% | $227 |
| Export certificate for medical devices | $221 | 2.58% | $227 |
| ARTG application for medical devices for export only | $104 | 2.58% | $107 |
| ARTG application for IVDs for export only | $104 | 2.58% | $107 |
4.9 CAB Designation Fees
The following fees apply to bodies applying to be designated by the TGA as Conformity Assessment Bodies (CABs), and are not product registration fees for general manufacturers.
| CAB application type | Current application fee | Estimated new application fee | Current assessment fee | Estimated new assessment fee |
|---|---|---|---|---|
| Full designation | $5,756 | $5,905 | $93,989 | $96,414 |
| Partial designation (full QMS) | $3,165 | $3,247 | $67,466 | $69,207 |
| Partial designation (partial QMS or partial devices) | $3,165 | $3,247 | $67,466 | $69,207 |
Fee notes
The fees above are reference amounts calculated from the current fee schedule in effect from July 2026 and the TGA’s proposed adjustment percentages, rounded to the nearest whole Australian dollar. Whether a specific item applies, whether additional audits are required, and other actual costs should be determined according to the relevant application.
The consultation document does not publish final AUD amounts for each fee item for the 2027-2028 financial year, so the figures above cannot be used as a basis for official payment.
5. Consultation Timeline and Proposed Implementation
According to the official TGA consultation document, this fee adjustment is still at the public consultation stage and has not yet received final government approval.
| Time | Milestone |
|---|---|
| 19 October 2026 | TGA launches public consultation |
| 16 November 2026 | Deadline for submissions |
| After the consultation closes | TGA reviews submissions and provides recommendations to the Minister for Health and Aged Care |
| After government approval | Amending instruments are submitted to the Federal Executive Council for consideration |
| 1 July 2027 | New fee schedule expected to take effect |
The TGA has also stated that it will publish an updated Cost Recovery Implementation Statement (CRIS) and an official fees and charges summary before the new fee schedule takes effect.
6. Official Documents and References
The policy adjustments described in this article are based solely on the official consultation documents of the Therapeutic Goods Administration (TGA):
6.1 2027-2028 Fees and Charges Proposal Consultation Document
‘2027-28 TGA Fees and Charges Proposal’:
6.2 Current Fee Schedule for 2026
‘Fees and Charges Summary – From 1 July 2026’
Official TGA consultation documents
Fee notes: the 2027-2028 amounts are estimates based on the current fee schedule in effect from July 2026 and the TGA’s proposed adjustment percentages, rounded to the nearest whole Australian dollar. They are not officially published new TGA fees and cannot be used as a basis for payment. Final fees and implementation arrangements are subject to official TGA announcements.