If you are bringing a medical device, in vitro diagnostic (IVD) test or medicine to Australia, the Therapeutic Goods Administration (TGA) charges you in two ways. You pay a one-off application fee to have your product entered on the Australian Register of Therapeutic Goods (ARTG), and then a yearly annual charge for every ARTG entry you keep. For example, from 1 July 2026 a Class IIa medical device costs A$1,244 to apply for and A$1,305 each year to keep on the register.
This guide sets out the official 2026–27 government fees, which apply from 1 July 2026, for medical devices, IVDs and listed medicines. It also covers the extra costs that catch people out, such as application audits, and what cosmetic businesses pay to the Australian Industrial Chemicals Introduction Scheme (AICIS) instead of the TGA. All figures come from the TGA and AICIS. Consultant fees are separate, and we explain how to read a quote further down. We update this post every 1 July, when the new fees take effect.
Government fees vs consultant fees
Your total cost of bringing a product to market usually has two parts:
- Government fees and charges, paid directly to the TGA (or to AICIS for industrial chemicals). These are set by law, they are the same for everyone, and they change every 1 July.
- Consultant or sponsor service fees, paid to a regulatory consultant such as R2 Pharma Solutions for preparing, lodging and managing your application. These vary by provider and by how much work your product needs.
The TGA uses two different words for its costs. A fee is charged for a service, such as assessing an application. A charge is a form of tax on the regulated industry, applied each financial year from 1 July to 30 June. Annual charges apply to every ARTG entry (except export-only products) that is on the register at any time during the financial year, even if you cancel it later that year.
Example: government cost for the first year
Using the 2026–27 TGA figures in the tables below, the government cost of one ARTG entry in its first year (application fee plus that year’s annual charge, before any audit fee) works out as follows:
- Class I medical device (non-sterile, no measuring function): A$651 + A$121 = A$772.
- Class IIa or IIb medical device: A$1,244 + A$1,305 = A$2,549.
- Class III medical device: A$1,603 + A$1,662 = A$3,265, plus a Level 1 or Level 2 audit fee if a mandatory audit applies.
- IVD (any class except Class 4 in-house): A$1,244 + A$948 = A$2,192, plus any audit fee.
- Listed medicine (AUST L): A$1,063 + A$1,566 = A$2,629.
After the first year, only the annual charge applies for each entry, and it is reset every 1 July. These examples leave out consultant fees, testing and any variation fees.
When you budget, add up the application fee, any audit fee and the first year's annual charge for each product, then add the annual charge for every following year you plan to keep it on the ARTG.
Medical device fees 2026–27
Medical devices are “included” in the ARTG (not listed or registered), and the fee depends on the device’s risk class. If you are still working out your class or pathway, our guide to the TGA medical device approval process explains the steps, and our medical devices page outlines how we help.
Application fees and annual charges by device class
Table 1: Medical device fees and charges from 1 July 2026
| Device class | Application fee | Annual charge |
|---|---|---|
| Class I – other (non-sterile, no measuring function) | A$651 | A$121 |
| Class I – sterile | A$651 | A$879 |
| Class I – measuring function | A$651 | A$879 |
| Class IIa | A$1,244 | A$1,305 |
| Class IIb | A$1,244 | A$1,305 |
| Class III, including active implantable medical devices (AIMDs) | A$1,603 | A$1,662 |
Source: TGA Fees and Charges Summary from 1 July 2026, Tables 40 and 41. Application fees exclude export-only devices. AIMDs have been classified as Class III since 25 November 2021, so new AIMD applications pay the Class III fee; the TGA still lists a separate AIMD annual charge of A$1,662, the same as Class III.
When annual charges are due
The annual charge applies each year to existing entries, and also in the year a product is first entered on the ARTG. Key dates:
- By 30 June: ask the TGA to cancel any ARTG entries you no longer supply. Entries still active on 1 July get the new year’s annual charge, unless they are exempt.
- 1–22 July: declare any entries that qualify for the Annual Charge Exemption (ACE) scheme, which covers products with no sales (a “$0 turnover” declaration). A late declaration is possible until 15 September, but a fee applies.
- 1–15 August: the TGA issues annual charge invoices for active ARTG entries.
- 15 September: payment in full is due by law.
- December: the TGA starts cancelling ARTG entries that have not been paid.
Put the 30 June cancellation deadline and the 15 September payment date in your calendar each year, so you are not charged for products you have stopped selling.
IVD fees 2026–27
In vitro diagnostic devices are tests used on samples taken from the body, such as blood or urine. Every IVD class pays the same application fee, and all classes except Class 4 in-house IVDs pay the same annual charge.
Table 2: IVD fees and charges from 1 July 2026
| IVD class | Application fee | Annual charge |
|---|---|---|
| All IVD classes (excluding export-only IVDs) | A$1,244 | A$948 |
| Class 4 in-house IVDs | A$1,244 | No annual charge |
Source: TGA Fees and Charges Summary from 1 July 2026, Tables 55 and 57.
Some IVD applications also need an application audit, which can cost far more than the application fee. See the audit section below.
Listed medicine fees 2026–27
Listed medicines are lower-risk medicines, such as many vitamins, herbal and other complementary medicines. They carry an AUST L number on the label. Sunscreens are also in this group. The fees are:
Table 3: Listed medicine (AUST L) fees and charges from 1 July 2026
| Fee or charge | Amount |
|---|---|
| Application fee | A$1,063 |
| Annual charge | A$1,566 |
| Request to vary an existing listing | A$537 |
Source: TGA Fees and Charges Summary from 1 July 2026, Table 7.
Registered medicines (AUST R), such as prescription medicines and registered over-the-counter medicines, are assessed case by case. Their costs depend on the application type and include evaluation fees as well as an application fee and annual charge, so we have not listed a single figure here. The TGA summary of fees and charges lists each type. For help with medicines, see our medicines and chemicals page.
What else can cost money: audits and extras
Some device and IVD applications must be selected for an application audit. The law decides which ones. An audit fee is then payable on top of the application fee. The TGA can also choose other applications for audit at its discretion, and those do not attract an audit fee. The TGA decides the audit level and sends you an invoice. If you do not pay the audit fee, your application lapses. In some cases where the audit can be shortened, the fee may be reduced.
Table 4: Application audit and priority fees from 1 July 2026
| Fee type | Amount |
|---|---|
| Medical device audit – Level 1 (checks your application, evidence of conformity and parts of compliance with the Essential Principles) | A$4,926 |
| Medical device audit – Level 2 (Level 1 plus an in-depth technical documentation review), Class III devices | A$18,118 |
| IVD audit – Class 3 IVDs and Class 4 IVDs (other than immunohaematology reagents) | A$25,350 |
| IVD audit – Class 4 immunohaematology reagent IVDs | A$18,821 |
| IVD audit – Class 3 or Class 4 IVDs not subject to laboratory testing as part of the audit | A$16,077 |
| Priority applicant determination (medical devices, including IVDs) | A$12,591 |
Source: TGA Fees and Charges Summary from 1 July 2026, Tables 42, 43, 58 and 59. Other audit rows (for example Class 1 and Class 2 IVDs, and Class 4 in-house IVDs) are in the TGA summary.
The “Essential Principles” are the TGA’s safety and performance requirements for medical devices. A priority applicant determination is a separate application to have a device application considered as a priority. It is not required for a standard application.
Cosmetics: AICIS, not the TGA
Most cosmetics are not entered on the ARTG. Instead, any business that imports or manufactures industrial chemicals in Australia, including the chemicals in cosmetics, must register with AICIS every year. The registration year runs from 1 September to 31 August, and payment is due by 1 September. (Sunscreens are different: they are listed medicines, so the Table 3 TGA fees apply.)
For 2026–27 the flat AICIS registration fee rose from A$80 to A$85, and AICIS assessment certificate fees and other service fees also increased from 1 September 2026. Level 1 businesses pay only the flat fee; Levels 2 to 8 also pay a charge based on the value of chemicals introduced.
Your AICIS level depends on the total value of the industrial chemicals you imported and manufactured in the previous financial year (1 July to 30 June). A new business that introduced nothing last year is Level 1. GST (goods and services tax) does not apply.
Table 5: AICIS registration costs, 1 September 2026 to 31 August 2027
| Level | Value of chemicals introduced last financial year | Fee | Charge | Total |
|---|---|---|---|---|
| Level 1 | A$0 to A$49,999 | A$85 | Nil | A$85 |
| Level 2 | A$50,000 to A$99,999 | A$85 | A$10 | A$95 |
| Level 3 | A$100,000 to A$249,999 | A$85 | A$20 | A$105 |
| Level 4 | A$250,000 to A$499,999 | A$85 | A$35 | A$120 |
| Level 5 | A$500,000 to A$2,999,999 | A$85 | A$210 | A$295 |
| Level 6 | A$3,000,000 to A$4,999,999 | A$85 | A$375 | A$460 |
| Level 7 | A$5,000,000 to A$14,999,999 | A$85 | A$2,450 | A$2,535 |
| Level 8 | A$15,000,000 or higher | A$85 | A$3,500 | A$3,585 |
Source: AICIS, “How much is my registration cost?”. Work out the value with AICIS’s calculator, not from sales or profit figures.
Our cosmetic regulations and AICIS page explains how we help cosmetic brands comply.
Why fees went up in 2026–27
The TGA must recover the cost of regulating therapeutic goods from industry, so it reviews its fees each year. According to the TGA’s 2026–27 Cost Recovery Implementation Statement, application and other fees rose by 4.8% from 1 July 2026 (3.3% indexation plus an extra 1.5%). Annual charges rose by about 6.1–6.4% depending on product type. For example, the Class IIa device annual charge is now A$1,305, and the IVD annual charge is A$948.
Because annual charges are rising faster than application fees, the yearly cost of keeping several products on the ARTG can matter more over time than the one-off cost of applying.
How to read a regulatory quote
When you compare quotes from consultants, it helps to separate the government costs from the service costs. What drives a consultant’s fee is the amount of work, not the TGA fee itself.
Check these points in any quote:
- Government fees shown separately. The TGA or AICIS amounts should match the tables above and be listed as pass-through costs.
- Number of ARTG entries. Fees and annual charges apply to each entry, so confirm how many entries your product range needs.
- First-year annual charge. Check whether the quote includes the annual charge for the year your product is entered, and who will pay future invoices.
- Audit fees. Ask whether a mandatory audit is likely and at which level, as this can add thousands of dollars.
- Consultant scope. Common cost drivers are the product’s risk class, how complete your evidence and technical documentation are, how many products are in the application, whether you need an Australian sponsor, and any ongoing support after approval.
Get a costed plan for your product
Not sure which class your product falls into, or what your total first-year cost will be? R2 Pharma Solutions can map out the government fees and our service scope for your product range, so you know what to budget before you apply. Contact us for a quote.
This post is a summary of public fee schedules, not regulatory advice; always check the TGA and AICIS for the latest figures.