TGA
Therapeutic Goods Administration (Australie)
Australia
Last reviewed 2026-08-05
La TGA réglemente les dispositifs médicaux en Australie selon le Therapeutic Goods Act 1989. L'Australie utilise un système de classification basé sur le risque aligné sur GHTF/IMDRF.
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.
CLASSES DE DISPOSITIFS
Class I, IIa, IIb, III, AIMD
VOIE D'APPROBATION
ARTG inclusion via conformity assessment
FONCTIONS RÉGLEMENTAIRES CLÉS
- ▸Enregistrement ARTG
- ▸Évaluation de conformité
- ▸Participation au MDSAP
- ▸Déclaration des événements indésirables
- ▸Surveillance post-commercialisation
SITE OFFICIEL
https://www.tga.gov.au →§ 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.
MedFlux surveille les changements réglementaires, alertes de sécurité et signaux de marché de TGA en temps réel.
SURVEILLER {abbr} GRATUITEMENT →