Australia Country Commercial Guide
Learn about the market conditions, opportunities, regulations, and business conditions in australia, prepared by at U.S. Embassies worldwide by Commerce Department, State Department and other U.S. agencies’ professionals
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Medical Devices
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Overview

TableMedical Devices Market Size, US$ million
 2020202120222023 estimated
Total Local Production1,4951,8562,0492,253
Total Exports1,3011,6151,7831,961
Total Imports4,4525,0965,0805,334
Imports from the U.S.1,4551,6321,5511,628
Total Market Size4,6465,3375,3465,626

(Total market size = (total local production + imports) - exports)

Units: $ millions

Data Sources: Local Production: Industry estimates 

Total Exports, Imports & Imports from the U.S.: GTA using HS 9018, 9019, 9021, 9022)

The Australian medical equipment industry sector has consistently provided good prospects for U.S. exporters. Australia is the eighth largest market globally for U.S. exporters of medical products, the third largest market for U.S. exporters in the Asia Pacific region, and ranks tenth in the near-term medical device export market rankings according to the https://www.trade.gov/top-export-market-rankings . 

In 2022, U.S. exports of medical equipment and supplies to Australia totaled US$1.5 billion, representing 3% of total medical equipment and supplies exports.

Approximately 85% of domestic demand for medical devices and diagnostics is met by imports while nearly all medical technology products manufactured in Australia are exported.  The three major suppliers of medical imports are the United States, China, and Germany.  The United States is the largest supplier of medical products, accounting for 31% Australia’s imports. 

U.S. medical equipment is traditionally well received due to its perceived high quality. The market is sophisticated, mature, and quick to adopt new healthcare technologies. Importers seek to obtain cost-effective and innovative products that will improve patient outcomes and reduce healthcare costs. 

Australia has a high per capita income, and there is demand for a full range of medical equipment. Opportunities exist for products that provide a significant improvement in clinical outcomes and products with clearly differentiated capabilities. There is also a growing demand for products that lead to faster patient recovery, reduce hospital and rehabilitation costs, and alleviate or manage disability and chronic pain.

The US$5 billion market is price sensitive and competitive. Australia spends approximately 9% of its GDP on healthcare, which is similar to the United Kingdom but less than the United States (16%). Australia’s aging population will significantly influence healthcare demand and products that serve the aging population are likely to experience market growth.

Both the public and private sectors provide healthcare in Australia, and as a result, government healthcare policies and public health influence the volume and pricing of healthcare products and services. Federal and State government spending accounts for 70% of total healthcare expenditure. The non-governmental sector (individuals and private health insurance) funds are the remaining 30%. Approximately 55% of Australians have private health insurance.

The Therapeutic Goods Administration (TGA) regulates the medical equipment industry. Australia’s regulatory framework is based on IMDRF guidelines which means that EU and Australian requirements are similar.  Depending on the category and classification of a medical device, the TGA will consider certain documents from overseas regulators and assessment bodies (including U.S. FDA, CE mark, and MDSAP certificate) that can be used for requests for abridgement of TGA conformity assessments or as the documentation required for applications for inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG).  For higher risk devices including all implants, the TGA conducts additional reviews before registration. U.S. exporters will need to appoint an Australian representative or sponsor to obtain regulatory approval from the TGA. 

Leading Sub-Sectors

Products that serve Australia’s aging population are likely to experience growth. BMI Research forecasts that the orthopedic and prosthetic market will be the fastest growing sector within the Australian medical device market over the next five years.

The leading causes of death in Australia are coronary heart disease, stroke, dementia (including Alzheimer’s disease), lung cancer, chronic obstructive pulmonary disease (principally emphysema and chronic bronchitis), breast cancer, prostate cancer, diabetes, and colorectal cancer. Although Australians are living longer, they are also increasingly suffering from chronic disease. Fifty percent of Australians are estimated to have at least 1 of 8 selected common chronic disease conditions: cancer, cardiovascular disease, mental health conditions, arthritis, back pain and problems, chronic obstructive pulmonary disease, asthma, and diabetes.

Opportunities

The demand for medical products and healthcare services is expected to grow for all age groups with continuing advances in medical technology, the increasing burden of chronic disease, the aging population, rising incomes and changing consumer expectations. Australians have one of the longest life expectancies in the world (sixth amongst the OECD countries) and demand will continue to increase as Australia’s aging population progressively relies on the health system for care.

Resources

Medical Organizations

Information for state government tenders in the three largest states is available at:

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