TGA
澳洲治療產品管理局
Australia
Last reviewed 2026-08-05
TGA根據1989年《治療產品法》監管澳洲醫療器材。澳洲使用與GHTF/IMDRF一致的風險分類體系。TGA是MDSAP參與機構。
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.
器材分類
Class I, IIa, IIb, III, AIMD
審批路徑
ARTG inclusion via conformity assessment
核心監管職能
- ▸ARTG註冊
- ▸合格性評估
- ▸MDSAP參與
- ▸不良事件報告
- ▸上市後監管
§ 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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