Medical Device Regulation in Australia
The Therapeutic Goods Administration (TGA) regulates medical devices under the Therapeutic Goods Act 1989. Devices must be included in the Australian Register of Therapeutic Goods (ARTG) before market access. Australia is an active MDSAP participant and aligns closely with IMDRF/GHTF principles.
Recent Regulatory Updates
Showing the latest 3 updates. Sign up to see more
New standardized AER terminology with codes.
Guidance on health facility software exclusion
Health comms software exclusion guidance
Sources Tracked by Qalico
Qalico continuously monitors 53 references across guidelines, regulations, and standards for Australia.
Guidelines
Device Classification
Class I: low risk, self-declaration. Class IIa/IIb: medium risk, conformity assessment required. Class III: high risk (e.g., cardiac stents), strictest conformity assessment. AIMD (Active Implantable Medical Devices): separate class for pacemakers, cochlear implants, etc. Classification mirrors EU MDD structure.
Official classification guidance →Official Guidance Documents
TGA's full guidance library: ARTG inclusion, conformity assessment, classification, and PMS.
Guide to the Essential Principles of Safety and Performance all devices must meet.
Step-by-step process for including a device in the Australian Register of Therapeutic Goods.
Standards & Key Principles
Applicable Standards
Key Principles
- Essential Principles of Safety and Performance (Schedule 1)
- Risk-based conformity assessment proportional to device class
- ARTG inclusion mandatory before supply
- MDSAP audit accepted in lieu of TGA on-site audit
- CE marking from recognized EU Notified Body accepted as conformity basis
- Australian Sponsor required for foreign manufacturers
Pre-Market Requirements
Manufacturer self-declares conformity with Essential Principles and notifies TGA. Lowest evidentiary threshold.
Application with Conformity Assessment Certificate (from TGA or recognized Notified Body), Essential Principles evidence, and clinical data. TGA reviews.
Required for Class IIa and above. Obtained from TGA or recognized overseas Notified Body (EU CE certificate accepted).
Post-Market Requirements
Sponsors must report serious adverse events to TGA within 30 days; urgent safety issues within 48 hours.
TGA monitors post-market data through ARTG, international sources, and adverse event databases.
Coordinated through TGA Recalls unit. Notices published publicly. Sponsor responsible for notifying customers.
International Recognition & Reliance
CE marking from recognized EU Notified Body accepted as basis for TGA conformity assessment (Class IIa, IIb, III).
FDA marketing authorization accepted as supporting evidence under MDSAP.
Shared MDSAP audit reports reduce duplicative inspections across all member countries.