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Australian Hospital Medical Device Management 2026 — TGA, HTA & Asset Tracking Guide
Complete guide to Australian hospital medical device management — TGA regulation, ARTG registration, Health Technology Assessment (HTA), asset tracking, maintenance, device recalls, and medical device software.
All medical devices in Australian hospitals must be TGA-registered and listed on ARTG. HTA evaluates new technologies. TGA manages device recalls. This guide covers Australian medical device management.
Medical Device Lifecycle
- Needs assessment: Identify clinical need for new device
- HTA: Health Technology Assessment — clinical and cost-effectiveness
- Procurement: Procure device (tender, evaluation, purchase)
- TGA/ARTG verification: Verify device is TGA-registered and on ARTG
- Asset registration: Register device in asset management system
- Installation and commissioning: Install, commission, and test device
- Training: Train staff on device use
- Maintenance: Regular maintenance and calibration
- Recall management: Manage device recalls and corrective actions
- Disposal: Safe disposal at end of life
TGA Device Classification
| Class | Risk Level | Examples | TGA Requirements |
|---|---|---|---|
| Class I | Low risk | Bandages, stethoscopes, wheelchairs | Self-declaration, ARTG listing |
| Class IIa | Medium risk | Surgical instruments, hearing aids | TGA assessment, ARTG |
| Class IIb | Medium-high risk | Infusion pumps, ventilators, ultrasound | TGA assessment, ARTG |
| Class III | High risk | Pacemakers, heart valves, implants | Full TGA assessment, ARTG |
| AIMD | Active implantable | Cochlear implants, neurostimulators | Full TGA assessment, ARTG |
Asset Management
- Asset register: Register all devices with serial number, location, TGA/ARTG number
- Barcode tracking: Barcode scan devices for tracking and maintenance
- Maintenance schedule: Schedule regular maintenance and calibration
- Maintenance records: Record all maintenance and repairs
- Recall tracking: Track device recalls and corrective actions
- Utilisation tracking: Track device utilisation and availability
- End-of-life: Track device end-of-life and replacement
Frequently Asked Questions
- What is TGA and ARTG?
- TGA (Therapeutic Goods Administration) regulates medical devices in Australia. ARTG (Australian Register of Therapeutic Goods) is the database of all TGA-approved medical devices. All medical devices used in Australian hospitals must be TGA-registered and listed on ARTG. TGA classifies devices by risk: Class I (low risk), Class IIa/IIb (medium risk), Class III (high risk), AIMD (active implantable).
- What is Health Technology Assessment (HTA) in Australia?
- HTA (Health Technology Assessment) in Australia is the process of evaluating new medical technologies for clinical effectiveness, cost-effectiveness, and safety. HTA is used by: 1) MBS (Medicare Benefits Schedule) for new procedures, 2. PBS (Pharmaceutical Benefits Scheme) for new medications, 3. State health departments for new equipment. MSAC (Medical Services Advisory Committee) conducts HTA for new MBS items.
- How do Australian hospitals manage device recalls?
- Australian hospital device recall management: 1) TGA issues recall notices via the TGA website and email alerts, 2. Hospital asset register identifies affected devices, 3. Affected devices are quarantined, 4. Clinical risk assessment — determine patient impact, 5. Alternative devices arranged, 6. TGA and supplier notified, 7. Corrective action implemented, 8. Documentation of recall and action taken.