Australia is a desirable market for most medical devices due to its mature, comparatively well-funded and stable healthcare system. However, entering this market is not without its challenges, in this article, our Director, Sarah Griffin will explore key considerations and offer insights for successfully accessing the Australian medical device market in 2024.


Understanding the Australian Healthcare System

The Australian healthcare system is mature, comparatively well-funded and stable.  It can be a rewarding market, however, entering this market requires careful consideration due to its complexities, high barriers to entry (in some cases) and unique economic incentives. As of 2024, understanding the nuances of the Australian healthcare landscape is crucial for successful market penetration.

Some of the barriers to entry may include:

  • In some instances, there are perverse economic incentives which can be difficult to understand.
  • The healthcare system is complex for a relatively small population. The public and private hospital systems, which are both highly regulated, operate in variable ways under Australia’s Medicare system which can be confusing and frustrating for those new to the Australian market.
  • To add to the complexity, the Federal and State government have different but intertwined responsibilities in the administration of the healthcare system.

Additionally on 11 September 2023, a major part of Australian Government’s Prostheses List Reform agenda was implemented, including changes to the Prostheses List, now known as the Prescribed List (PL), with a new application process and platform and the introduction of cost recovery for applications. If you would like to learn more about these changes read our recent article: The Prescribed List (formerly Prostheses List) Update – 2023.


If you are considering marketing a medical device in Australia, it is wise to consider the following:

  • Is there a medical service funded by the Australian Medicare System that encompasses the use of the medical device?

If not, do you need to apply to the Australian Government’s Medical Services Advisory Committee (MSAC) for coverage for a new medical procedure?

  • What clinical and economic evidence is required for an MSAC application?  What are the timelines and costs?
  • Is the device used in an outpatient or inpatient setting? This has implications for reimbursement.
  • Is the device implantable? There are good opportunities in the private sector for specific device reimbursement over and above other admission costs. This is covered by the Australian Government’s Prescribed List of Medical Devices (PL)
  • If the device is not implantable, can it still be included on the PL/
  • What are the timelines, costs, and clinical and economic evidence requirements for an application to be included on the PL?
  • What is the available funding for the device in the public hospital sector?

The Importance of Feasibility Studies

In our experience, a common pitfall for companies entering the Australian market is insufficient preparation and unrealistic expectations. Feasibility studies, especially for innovative technologies, are invaluable. We always recommend commissioning a feasibility study before initiating the application process.  This is particularly important for innovative and breakthrough technology.

Additionally, some companies underestimate the clinical evidence requirements for major submissions and attempt these prematurely. This can result in highly costly delays and resubmissions.

What will a feasibility study provide?

A feasibility study (also known as a feasibility assessment) will:

  • outline the available pathways for reimbursement for a medical device in Australia, including timelines and costs.
  • a realistic assessment of the available clinical evidence and the proposed price of the device.


At MedTechnique Consulting, we specialise in undertaking feasibility assessments for clients entering the Australian market. Our experience has shown that clients often adjust their plans based on a thorough understanding of the landscape. Some choose to delay applications, saving valuable resources, while waiting for additional evidence or meeting specific requirements.

This strategic approach minimises costly delays and increases the likelihood of a successful outcome. Find out more about our feasibility services and read our client case study here: Case Study


Entering the Australian medical device market requires considered planning and a nuanced understanding of the complex healthcare system. A well-informed approach, supported by thorough feasibility studies/assessments, can save resources, and pave the way for successful market access.  The team at MedTechnique Consulting are dedicated to helping companies navigate this journey, ensuring a strategic and informed entry into the Australian market.



If you are considering entering the Australian market with your medical device or have any questions about accessing the Australian market, contact us today. MedTechnique Consulting has helped many organisations navigate the Australian healthcare landscape, gain market access, and submit successful reimbursement applications.

Email: or Phone: + 61 448 058 600.

About the Author

Sarah Griffin, Director of MedTechnique Consulting. Sarah is an experienced health economist, reimbursement strategist, health policy advocate and speaker.

Connect with Sarah Griffin on LinkedIn.

If you would like to learn more about Sarah’s speaking experience for your next event please email: Kim MacDonald, Spindrift Marketing.

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