TGA
澳大利亚治疗产品管理局
Australia
Last reviewed 2026-08-05
TGA根据1989年《治疗产品法》监管澳大利亚医疗器械。澳大利亚使用与GHTF/IMDRF一致的风险分类体系。TGA是MDSAP参与机构。
TGA AND THE ARTG
Australia’s Therapeutic Goods Administration (TGA) regulates medical devices under the Therapeutic Goods Act. Most devices must be included in the Australian Register of Therapeutic Goods (ARTG) before supply. Classification rules are risk-based and broadly aligned with GHTF/IMDRF concepts, but Australian-specific essential principles and sponsor obligations still apply.
CONFORMITY ASSESSMENT AND MDSAP
Depending on class, manufacturers provide conformity assessment evidence—often leveraging EU Notified Body certificates, MDSAP audit reports, or TGA conformity assessment. Australia participates in MDSAP, which can reduce duplicate QMS audits for multi-market manufacturers also selling in the US, Canada, Brazil, or Japan.
POST-MARKET EXPECTATIONS
Sponsors must report adverse events, manage recalls, and maintain ARTG entries when device details change. Global safety signals (FDA Class I recalls, EU FSCA) often trigger Australian sponsor assessments even when the ARTG entry remains active. Continuous monitoring shortens that assessment lag.
器械分类
Class I, IIa, IIb, III, AIMD
审批路径
ARTG inclusion via conformity assessment
核心监管职能
- ▸ARTG注册
- ▸合格性评估
- ▸MDSAP参与
- ▸不良事件报告
- ▸上市后监管
§ RELATED INTELLIGENCE
§ FAQ
What is the ARTG?
The Australian Register of Therapeutic Goods (ARTG) is the public register of therapeutic goods—including medical devices—that can be legally supplied in Australia. Inclusion typically requires a sponsor established in Australia and suitable conformity assessment evidence for the device class.
Does TGA accept CE certificates?
TGA often accepts certain EU conformity assessment evidence as part of Australian applications, subject to current comparable overseas regulator / abridged pathways and documentation rules. Acceptance is not automatic for every device class—check TGA guidance for the applicable evidence matrix.
How does MDSAP relate to TGA?
Australia is an MDSAP participating regulatory authority. A single MDSAP audit can support QMS evidence for multiple markets, including Australia, reducing audit fatigue for manufacturers selling across MDSAP countries.
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