Australia's type 1 diabetes market presents opportunities for medical device companies, particularly in continuous glucose monitoring (CGM), as government subsidies support access to diabetes technologies. This article examines market growth, reimbursement arrangements and key Therapeutic Goods Administration (TGA) requirements, including Australian Register of Therapeutic Goods (ARTG) inclusion and unique device identification (UDI) compliance. It also outlines practical considerations for companies planning to enter the Australian market.

Market at a glance

Reimbursement is shaping demand

In Australia, funding sets the pace of device uptake as much as clinical need does.

• Children and young adults under 21 and concession card holders can access subsidised CGM through the NDSS, subject to program eligibility requirements. Other eligible adults may need to pay a co-payment. The government has highlighted previous CGM costs of up to A$5,000 (approximately US$3,510) a year, illustrating the potential financial burden without subsidy.2
• The FreeStyle Libre 2 Plus joined the NDSS subsidy list on 1 April 2025.6
• Funded CGM access and the expanded Insulin Pump Program sit within a A$273.1 million (approximately US$191.8 million), four-year commitment,2 while current NDSS product supply contracts run to 30 June 2027,7 so renewal arrangements are worth watching.
• The pump programme funds only 35 fully subsidised pumps nationally each year.2 This is a targeted safety net for eligible young adults aged 18 to 21 facing financial hardship, rather than broad coverage. Patients who do not qualify for assistance may need to fund their pumps themselves.

For suppliers, NDSS listing is the commercial gateway. The Medical Services Advisory Committee has assessed diabetes products for NDSS subsidy since November 2020,9 and the Department of Health consulted in 2023 on a tender to refresh the NDSS Product Schedule.10 Suppliers should confirm current listing arrangements before committing to a launch plan.

Growth is concentrated in glucose monitoring

• Australia's CGM market is expected to grow from US$178.21M in 2025 to US$448.08M by 2031, a 16.61% yearly growth rate (2026 to 2031). NDSS reimbursement expansion is the largest single growth driver.3
• The broader diabetes devices market is projected to grow from US$721.44M to US$832.6M over the same period, or 2.43% a year. High out-of-pocket costs for pump consumables are cited as a restraint.4
• Beyond CGM, other diabetes device categories may also offer opportunities, including insulin pumps and related consumables, insulin pens, pen needles, blood glucose test strips and diabetes monitoring software. Market potential and regulatory requirements vary by product category. For insulin-delivery products supplied with insulin, the applicable TGA classification should be confirmed based on the specific product configuration, as certain device-medicine combinations may be regulated under a different pathway.

These forecasts suggest that growth prospects differ across diabetes device categories. Manufacturers should assess the specific segment relevant to their products rather than treating the broader diabetes devices market as a uniform opportunity.

Regulatory pathway: what device makers need to plan for

• ARTG inclusion. The sponsor prepares the application, and the documents required depend on the device's classification and applicable regulatory pathway.10
• Evidence. Applicants must provide the conformity assessment evidence and supporting documentation required for the device and application pathway. Depending on the circumstances, this may include a TGA conformity assessment certificate or eligible evidence from a recognised overseas regulator or assessment body, together with appropriate clinical evaluation. Overseas approval does not automatically guarantee ARTG inclusion.10 11
• Unique device identification (UDI). Mandatory UDI requirements for Class IIb and Class III medical devices commenced on 1 July 2026. The implementation schedule provides for applicable UDI labelling requirements across device classes by 31 December 2029 and direct marking by 30 June 2030, subject to applicable exemptions and transitional arrangements. Sponsors and manufacturers should determine their obligations for each product and maintain the relevant device information in the Australian UDI Database (AusUDID).5

Whether a given CGM system, insulin pump or related product falls into a particular class depends on its Australian classification and intended purpose. Manufacturers should confirm the classification and applicable regulatory pathway early in their market-entry planning.

Business implications

Demand for glucose monitoring and insulin delivery in Australia is influenced by reimbursement, affordability and regulatory requirements. CGM is a notable growth segment, while other diabetes devices may offer opportunities depending on product positioning and market needs.

For device companies, three points shape market entry:

• Reimbursement drives volume. NDSS listing, co-payment levels and any change to the product schedule affect uptake more than list price alone.
• Regulatory work is front-loaded. Sponsor arrangements, ARTG inclusion, conformity evidence, clinical evaluation and UDI readiness should be planned together.
• Competition is concentrated. Manufacturers should assess how their products can stand out through clinical performance, usability, connectivity, compatibility, service support or cost.

Market entry should therefore be assessed on a product-specific basis, including Australian classification, evidence requirements, reimbursement route and local commercialisation strategy.

Considering opportunities in Australia's diabetes device market?

Qualtech's regulatory experts can support product classification, TGA registration strategy, clinical evidence requirements and post-market compliance, providing local regulatory insight throughout your market-entry process.

Contact us to evaluate the most suitable regulatory pathway for your device.

References

1. Australian Diabetes Society, 2026–27 Pre-budget Submission to the Australian Government: Diabetes.
2. Department of Health, Albanese Government delivering life-changing devices for Australians with Type 1 diabetes.
3. Mordor Intelligence, Australia Continuous Glucose Monitoring Devices Market.
4. Mordor Intelligence, Australia Diabetes Devices Market.
5. TGA, The Australian Unique Device Identification (UDI) system.
6. NDSS, FreeStyle Libre 2 Plus subsidised by the NDSS.
7. Department of Health and Aged Care, Request for Proposal to refresh a selection of products on the National Diabetes Services Scheme (NDSS) Product Schedule (ATM ID: Health23-24/22-12900)
8. Department of Health, National Diabetes Services Scheme (NDSS).
9. Department of Health, Consultation: National Diabetes Services Scheme (NDSS) Products (2023).
10. TGA, ARTG inclusion documentation for medical devices.
11. TGA, Medical device reforms: comparable overseas regulator marketing approvals.