MEDICAL EQUIPMENT
Australia
Overview
Value of the Australian Medical Equipment (Millions US$)
| x | 2004 | 2005 | 2006 (Estimated) |
| Total Market Size | 2759 | 3076 | 3667 |
| Total Local Production | 993 | 1107 | 1320 |
| Total Exports | 655 | 806 | 1007 |
| Total Imports | 1766 | 1970 | 2348 |
| Imports from the U.S. | 728 | 795 | 956 |
Exchange rates:
2004 0.74
2005 0.76
2006 0.75
The above statistics are unofficial estimates.
Medical equipment is one of Australia’s best markets for U.S. exporters. More than 85 percent of devices and diagnostics used in Australia are imported. Approximately 60 percent of these products come from the U.S. Other major market suppliers are Germany, Japan and the EU.
Australia has a sophisticated healthcare system and is a mature market for medical equipment. A large number of small companies and a small number of multinational firms serve the market. As the world's largest producer of medical equipment, most of the major U.S. medical companies are represented in Australia, either through local representatives or subsidiary companies.
More than 1,100 companies are involved in the medical device and diagnostics industry in Australia. The market is valued at approximately US$3 billion, representing about one percent of the global market. Australia’s health expenditure, as a proportion of GDP, is comparable to other OECD countries including Canada, France and the Netherlands. Australia’s spending on healthcare is approximately 9.7 percent of GDP which is more than the U.K. and Japan, but less than the U.S. The most recent OECD report ranked Australia 10th in terms of health spending as a proportion of gross domestic product in 2003.
Health provisions and funding is provided through a combination of the public and private sectors. Australia has a government-funded healthcare scheme with the Government being the primary purchaser of medical equipment. The Federal government funds approximately 46 percent of all health spending, the State governments 22 percent and the private sector 32 percent. Public hospitals account for approximately 70 percent of sales of medical equipment, while 30 percent of sales are made to the private sector. As the costs of maintaining a public healthcare system are increasing, public hospital administrators and medical staff are directed to choose the best product available at the lowest possible cost. The quality of health provided is high in both the private and public sectors.
The medical equipment market in Australia is regulated by the Therapeutic Goods Administration (TGA). Australia’s regulatory framework is harmonized with international accepted best practice, and is based on the guidelines of the Global Harmonization Task Force (GHTF) and the European Community (EC) requirements.
If a U.S. manufacturer does not have a European Union European Community certificate, it should apply for a European Community certificate from a European Union Notified Body. If this is not possible, the manufacturer can apply to the TGA for a Conformity Assessment Certificate and undergo conformity assessment by the TGA.
Medical devices are classified according to the degree of risk associated with their application. As approval for sale in Australia can only be obtained by an Australian sponsor, U.S. exporters need to appoint an Australian representative before their products can be approved by the TGA.
Best Products/Services
Although a relatively small market, Australia’s high per capita income means that there is demand for the full range of sophisticated medical equipment. In addition, Australia enjoys a high standard of medical practice. This, together with the expectation of state-of-the-art medical treatment by an educated population, ensures a continuing need for high quality and innovative medical equipment and products.
Government policy and activity in the provision of public health services is a major factor in the demand for medical equipment. Nonetheless, the provision of health services by the private sector is increasing. Further increases are likely due to the rise in the number of Australians with private health insurance and the expanding role of the private sector in the care of Australia’s ageing population. The public demand for improved healthcare services will continue to increase.
U.S. medical equipment is traditionally well received in Australia due to its perceived high quality. Opportunities exist for state-of-the-art and innovative medical equipment and products that can result in a significant improvement in clinical outcomes. In particular, products that serve Australia’s ageing population are likely to experience growth.
Under the Free Trade Agreement between the U.S. and Australia (AUSFTA), medical equipment continues to receive duty-free treatment. In addition, U.S. firms can compete for Australia’s government purchases on a nondiscriminatory basis.
Resources
Australian Therapeutic Goods Administration: http://www.tga.gov.au/
Australian Department of Health and Ageing: http://www.health.gov.au/
U.S. companies seeking information on the Australian healthcare industry are encouraged to contact Monique Roos at the U.S. Commercial Service in Sydney
(email: monique.roos@mail.doc.gov ).