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

Approximately 95 percent of medical devices and diagnostics are imports. The three major suppliers are: the United States, the European Union, and Japan. We anticipate the demand for medical equipment will be fairly flat in 2009, and the weakening Australian Dollar will affect the overall demand, particularly for new products.

Australia’s spending on healthcare is approximately 9 percent of GDP, which is more than that in the United Kingdom (8.3 percent), similar to Italy’s (8.9 percent), and less than the United States’ (15.3 percent).

Many of the major U.S. manufacturers have local representation or subsidiaries in Australia. These companies include: Bard, Baxter Healthcare, Boston Scientific, Cook Medical, Johnson & Johnson Medical, Medtronic, St. Jude Medical, and Stryker. Large, multinational firms dominate the Australian market. Small to medium-sized importers and distributors comprise the remainder of the industry.

Health provisions and funding comes from the public and private sectors. With Australia’s government-funded healthcare scheme, the Government is the primary purchaser of medical equipment. The Federal and State governments fund approximately 68 percent of healthcare spending. The private sector funds the remaining 32 percent. Public hospitals account for approximately 70 percent of purchases of medical equipment, with the remaining 30 percent from the private sector.

The Therapeutic Goods Administration (TGA) regulates the medical equipment industry. Australia’s regulatory framework is based on Global Harmonization Task Force (GHTF) and European Community guidelines. U.S. exporters must appoint an Australian representative/sponsor to obtain regulatory approval from the TGA. U.S.-manufactured medical devices require an EC Certificate from a European Union Notified Body. Alternatively, U.S. manufacturers can apply to the TGA for a Conformity Assessment Certificate.

Best Products/Services

The medical equipment industry sector has consistently provided good prospects for U.S. exporters. U.S. medical equipment is traditionally well-received in Australia 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.

Prices and volumes are influenced by government healthcare policies and provisions of public healthcare services. Products that serve Australia’s ageing population are likely to experience growth. Diseases and illnesses for which incidence and prevalence rates are projected to increase include: diabetes, cerebrovascular disease (stroke), ischaemic (coronary) heart disease, lung cancer, and musculoskeletal disorders.

Resources

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