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Australia
市场信息
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.
医疗器械监管
Therapeutic Goods Administration (TGA), under the Department of Health and Aged Care.
分类、费用、时间表
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 |
产品注册途径
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 |
有用信息
许可证有效期：5年。
许可证转让：现有许可证持有人必须向TGA提交转让表格和制造商证明，并支付每份申请360美元。
进口商和分销商：本地许可证持有人代表产品所有者负责任命进口商和分销商。
