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Market Information
Australia’s healthcare expenditure is estimated at $105.8 billion in 2022-2023, representing 16.8% of the Australian Government’s total expenditure.
Market Trend: Forty five percent of Australians, or 11.8 million people, had private health insurance coverage for hospital treatment as of December 2022.
Australia’s medical equipment market revenue is expected to show an annual growth rate (CAGR 2023-2028) of 6.50%, resulting in a market volume of US$10.15bn by 2028.
The Therapeutic Goods Administration is the medicine and therapeutic regulatory agency of the Australian Government founded in 1989. As part of the Department of Health and Aged Care, the TGA regulates the quality, supply and advertising of medicines, pathology devices, medical devices, blood products and most other therapeutics.
Medical Device Regulation
Therapeutic Goods Administration (TGA), under the Department of Health and Aged Care.
Classification, Fees, Timeline
DEVICE CLASS | FEES | TIMELINE |
|---|---|---|
Class I - Measuring | $575 | 4 weeks |
Class I - Sterile | $575 | 4 weeks |
AIMD | $1,370 | 6 months |
Class IIa | $1,098 | 4 weeks |
Class IIb | $1,098 | 6 weeks |
Class III | $1,416 | 6 months |
Product Registration Routes
DEVICE CLASS | DESCRIPTION |
|---|---|
Class I | Low risk (Measuring / Sterile) |
Class IIa | Low to moderate risk |
Class IIb | Moderate to high risk |
Class III | High risk |
AIMD | Active Implantable Medical Devices |
Useful Information
Validity of License: 5 years.
License transfer: The existing license holder has to submit transfer form and manufacturers evidence to TGA and pay $360 per application.
Importer and Distributor: Local License Holder, on behalf of the product owner, is responsible to appoint Importers and Distributors.
