For further information on the Medical Equipment industry in Australia, please contact Commercial Specialist Monique Roos, U.S. Commercial Service Sydney on Tel: (+61-2) 9373-9210, Fax: (+61-2) 9221-0573, Email: monique.roos@N0SPAM.mail.doc.gov

Overview

The medical equipment industry sector provides excellent prospects for U.S. exporters. Approximately 85 to 90 percent of devices and diagnostics in Australia are imports. The U.S. is the major supplier, followed by Germany, Japan, and the EU. Two Australian companies, Cochlear and ResMed, dominate local production, which is minimal. Australia exports most of its locally-manufactured medical devices.

The demand for medical products is growing due to the increasing affluence of the population, the increase in life expectancy, and the demands for a higher quality of life. Australia has a sophisticated healthcare system and is a mature market for medical equipment. Many of the major U.S. medical companies are represented in Australia, either through local representatives or subsidiary companies including: Bard, Baxter Healthcare, Boston Scientific, Cook Medical, Johnson & Johnson Medical, Medtronic, St. Jude Medical, and Stryker.

A large number of small companies and a small number of multinational firms serve the market. About 1,100 companies are involved in the medical device and diagnostics industry in Australia. The market value is approximately US$2.5 billion, representing about one percent of the global market. Australia’s spending on healthcare is approximately 8.8 percent of GDP which is more than in the U.K. and Japan, less than in the U.S., but comparable to that in Canada, Sweden, and Italy.

Health provisions and funding comes from 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, with the remaining 30 percent to the private sector. As the costs of maintaining a public healthcare system are increasing, public hospital administrators and medical staff must choose the best product available at the lowest cost. The quality of health provided is high in both the private and public sectors.

The Therapeutic Goods Administration (TGA) regulates the medical equipment market in Australia. 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, the manufacturer should, in the first instance, 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. U.S. exporters need to appoint an Australian representative/sponsor to obtain regulatory approval by the TGA.

Best Products/Services

Although a relatively-small market, Australia’s high standard of medical practice means that there is a continuing need and demand for the full range of sophisticated, high quality, and innovative medical equipment.

Government policy and activity in the provision of public health services is a major factor in the demand for medical equipment. Nonetheless, private sector purchases of health services are 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.

Due to its perceived high quality, U.S. medical equipment is traditionally well-received in Australia. 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, prostheses, in vitro diagnostics, and products that serve Australia’s ageing population are likely to experience growth.

Resources

Australian Therapeutic Goods Administration: http://www.tga.gov.au/
Australian Department of Health and Ageing: http://www.health.gov.au/