When planning global medical device clinical trials and early commercialization, a growing number of manufacturers are conducting clinical trials in Australia. Access to innovative medical services, an established healthcare infrastructure, and a clear, well-precedented regulatory environment make the region advantageous for clinical research.
While the country’s public health insurance program — Medicare — does not offer reimbursement for medical device clinical trials, it does allow for the reimbursement of certain medical devices approved for sale in Australia. If obtaining commercial approval in Australia is a goal, data from clinical trials conducted in Australia may offer at least an efficiency advantage when submitting information to the Australian government’s Therapeutic Goods Administration (TGA), which regulates medical devices.
Why Australia?
Aside from beautiful beaches and good wine, Australia boasts a robust clinical research sector supported by government.
Conducting clinical trials in Australia offers several financial, clinical, and operational advantages:
- One of the best healthcare systems in the world. The Commonwealth Fund ranked Australia’s public-private system third in the world, and many of its clinical practices resemble those of the U.S. and the U.K.
- Top-tier research facilities. Australia is internationally known as a clinical research center. The country adheres to good clinical practice (GCP) standards, which means its data are accepted by most regulatory agencies, including the FDA. International Conference on Harmonisation (ICH) and International Organization for Standardization (ISO) GCP standards are mandatory for all clinical trials conducted in Australia.
- Significant tax incentives. The Australian government provides a research and development tax incentive to businesses investing in R&D activities, including clinical trials. Businesses with annual revenues of less than $20 million AUS receive a 45% tax offset, while businesses with higher revenue receive a 40% tax offset. Medical device manufacturers based outside of Australia should consider creating a business entity or subsidiary in Australia to take advantage of this benefit.
Two Paths to Device Reimbursement: MBS and the Prostheses List
Australia offers two distinct routes to reimbursement, depending on the device type. Understanding which one applies, and preparing for it early, shapes how a clinical and regulatory strategy should be built.
MBS Pathway for Regulated Devices
Procedures and their associated devices must appear on the Medicare Benefits Schedule (MBS) to receive reimbursement from Medicare and from private health insurers. Ideally, a device falls under a procedure already listed on the MBS, since applying to add a new procedure is a long and demanding process.
Avania’s market access team has direct experience with the Australian market and can support both MBS item number selection and application.
Prostheses List Pathway for Implantable Devices
Companies bringing implantable devices into the Australian market can apply for inclusion on the Prostheses List, governed by the Prostheses List Advisory Committee (PLAC), to receive reimbursement. Regulatory approval must be obtained either before or in parallel with a Prostheses List application.
Private health insurers pay a specific benefit for devices on this list, which currently includes more than 11,000 joint replacement devices, cardiac implantable devices, stents, infusion pumps, catheters, and cardiac remote monitoring systems. Upon receipt of an application, the device’s clinical effectiveness and other characteristics are reviewed by a Clinical Advisory Group, the PLAC, and the Australian government’s Minister of Health. The entire process takes about four to six months.
How to Increase Your Odds of Reimbursement Approval
As with U.S. clinical trials, manufacturers must factor reimbursement into the clinical trial planning process as early as possible. When designing the protocol and determining what data to gather, consider the following:
- Optimize clinical trial design. Design your clinical trial so it produces as much valuable information as possible for regulatory and payer organizations.
- Focus less on price, more on value. While your product may deserve premium pricing, know that Australia prioritizes value. Demonstrate how your product reduces healthcare costs and consider these metrics when planning clinical trials.
- Don’t plan to negotiate. Australia’s payer system offers a fixed price for medical devices. Hospital systems have a set budget to work with, which leaves little to no room for negotiation.
Avania in Australia: Local Presence, Global Backing
Avania supports MedTech manufacturers in Australia from two local offices, in Melbourne and Sydney, both operating under Avania’s ISO/IEC 27001-certified quality management system. That local footprint is backed by
Avania’s global market access team, who work extensively within the MBS and Prostheses List frameworks described above, alongside coverage and coding support across 22 global markets.
For manufacturers weighing Australia against other early-stage markets, our success stories show how Avania’s teams have carried sponsors through similarly complex, multi-region regulatory and reimbursement programs.
FAQ
What is the difference between MBS and Prostheses List reimbursement in Australia?
The Medicare Benefits Schedule (MBS) covers reimbursement for procedures and their associated non-implantable devices, while the Prostheses List covers implantable devices such as joint replacements, cardiac devices, and stents. Implantable devices generally need Prostheses List inclusion in addition to, or instead of, an MBS item number.
How long does it take to get a device added to the Australian Prostheses List?
The Prostheses List review process, from application through Clinical Advisory Group and Prostheses List Advisory Committee review to the Minister of Health’s decision, typically takes about four to six months.
Does Australia offer tax incentives for medical device clinical trials?
Yes. Australia’s research and development tax incentive offers a 45% offset for businesses with less than $20 million AUS in annual revenue and a 40% offset above that threshold, including for clinical trial activity.
Can Avania support both TGA regulatory submissions and reimbursement strategy in Australia?
Yes. Avania’s Melbourne and Sydney offices work alongside the global market access team to support both regulatory pathways through the TGA and reimbursement pathways through the MBS and Prostheses List.
Is Australia a good location for early feasibility studies for medical devices?
Many manufacturers use Australia for early feasibility and first-in-human work because of its GCP-aligned regulatory environment, healthcare system quality, and R&D tax incentives, which can offset trial costs even before a reimbursement pathway is finalized.