Australia provides universal health care for its 23 million residents. 100% of the population is covered through the public Medicare system, and around 55% of the population purchases additional Private Health Insurance. The private system comprises 35 private insurers, spending $US 12.5 billion per annum. The public hospital system spends approximately $US 26 billion per annum. Australia spends about 9% of its GDP on the health care industry.
In Australia, medical devices are regulated by the Therapeutic Goods Administration (TGA). The respective rules are stipulated in the Therapeutic Goods Act 1989, the Therapeutic Good Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002. A medical device can only be marketed in Australia if it is registered in the Australian Register of Therapeutic Goods (ARTG).
Similarly to an European Authorized Representative, foreign manufacturers need a local Sponsor as a point of contact. The Sponsor must be an Australian entity, such as a person or company with Australian residency. They have to assume roles, such as procedure organization, TGA registration, guarantee compliance with essential principles and conformity assessment, and annual payments among others. Often the EU-required CE certification is accepted for non-Australian manufacturers to prove their conformity.
Certain medical devices qualify for reimbursement. Concurrent with a TGA application, the local Sponsor can apply to have a product reimbursed. If successful, that product will be awarded a fixed price, which can be determined prior to registration. With successful registration, a product will be reimbursed by all insurers for every hospital in Australia.
The last step in Australian market access is distribution. The local market is concentrated in 5 geographic areas, namely Sydney, Melbourne, Adelaide, Perth and Brisbane, all thousands of kilometres apart. Even though the distribution market is well developed, it is important to understand the local market and assess the best-suited representative for the product and area.