Australia Medical Device Registration (TGA – Therapeutic Goods Administration)
1. Regulatory Authority & Framework
Australia regulates medical devices under:
- Therapeutic Goods Act 1989
- Therapeutic Goods (Medical Devices) Regulations 2002
- Australian Regulatory Guidelines for Medical Devices (ARGMD)
Authority:
TGA – Therapeutic Goods Administration
Registration database:
ARTG – Australian Register of Therapeutic Goods
Australia fully aligns with IMDRF/GHTF principles.
2. Device Classification (Class I / IIa / IIb / III / AIMD)
Australia uses the same risk system as EU/GHTF:
| Class | Risk Level | Examples |
|---|---|---|
| Class I | Low | Non-sterile, non-measuring devices |
| Class Is / Im | Low | Sterile or measuring Class I |
| Class IIa | Low–Moderate | Suction pumps, infusion devices |
| Class IIb | Moderate–High | Blood glucose meters, electrosurgical units |
| Class III / AIMD | High | Implantables, ventilators, surgical robots |
Classification rules identical to EU MDR (intended use, invasiveness, duration, etc.).
3. Registration Pathways (ARTG Inclusion)
3.1 Conformity Assessment (CA) Routes
All devices must have a valid Conformity Assessment (CA) before ARTG inclusion.
Options:
Route A – TGA Conformity Assessment Certificate
- TGA performs full CA evaluation
- Required for some high-risk devices (Class III, AIMD) if no EU/TGA approvals available
- Longest route (9–18 months)
Route B – Leverage Overseas Certificates / Evidence (Fastest Route)
Australia accepts CA evidence from comparable regulators:
- EU CE Certificate (MDR or MDD legacy)
- US FDA 510(k)/PMA
- Health Canada licence
- Japan PMDA/MHLW approvals
- ISO 13485 QMS certification
This overseas evidence is the standard approach for most companies.
4. ARTG Inclusion (Final Step)
After CA evidence is accepted:
- Sponsor (local representative) submits an ARTG inclusion application
- Device enters the ARTG (similar to device listing/registration)
- Low-risk Class I may be auto-included
- Higher classes may undergo TGA review (targeted, not full assessment)
5. Local Sponsor Requirement (Mandatory)
Foreign manufacturers cannot register directly; must appoint an Australian Sponsor.
Sponsor responsibilities:
- ARTG inclusion
- Importation & distribution
- Adverse event reporting
- Recalls & FSCA
- Labeling compliance
- Maintaining documentation for audit
- Periodic reporting
Sponsor holds the ARTG entry (strategically important).
6. Dossier Requirements (CA + ARTG Submission)
Administrative Documents
- Manufacturer evidence (CE Certificate / FDA clearance / ISO 13485)
- Australian Sponsor letter
- Declaration of Conformity
- QMS documentation
- Free Sale Certificate (if applicable)
Technical Documentation (GHTF/IMDRF-aligned)
- Device description
- Essential Principles compliance (equivalent to EU GSPRs)
- Risk management (ISO 14971)
- Verification & validation
- Biocompatibility
- Electrical safety (IEC 60601)
- Software documentation (IEC 62304, cybersecurity)
- Clinical evidence (CER)
- Sterilization validation
- Labeling & IFU
For ARTG post-market audits, TGA may request full technical documents.
7. Fees & Timelines
TGA Government Fees (Typical)
- Class I: AUD ~1,000–2,000
- Class IIa: AUD ~2,500–3,500
- Class IIb: AUD ~3,500–5,000
- Class III/AIMD: AUD ~4,000–7,000
- Conformity Assessment (if TGA-reviewed): AUD 25,000–60,000+
Timelines
| Step | Typical Duration |
|---|---|
| Sponsor appointment | 1–2 weeks |
| Overseas evidence acceptance | 2–8 weeks |
| ARTG inclusion | 1–3 months |
| Full TGA CA (if required) | 9–18 months |
Fastest route for CE/FDA-cleared devices: 2–3 months.
8. Labeling Requirements
Labeling must follow TGA Essential Principles:
- Device name/model
- Manufacturer details
- Australian Sponsor details
- UDI/GTIN (phased implementation)
- Expiry/manufacture date
- Storage/handling conditions
- IFU (English required; electronic IFU acceptable for some devices)
9. Importation Requirements
- Importer must comply with Australian customs
- Sponsor ensures that devices meet ARTG conditions
- Post-market monitoring through VIC/IRIS reporting systems
- Compliance with Australian Consumer Law for claims
10. Post-Market Surveillance
Australia has strong PMS obligations:
- AE reporting (IRIS)
- FSCA
- Recalls
- Post-market reviews/audits by TGA
- Record retention (≥5–10 years depending on class)
- Clinical performance monitoring for high-risk devices
11. Consulting Summary for Your Product Portfolio
| Device Type | Likely Class | Australia Notes |
|---|---|---|
| Soft contact lenses | Class IIb | Needs biocompatibility + clinical evidence; CE/FDA benefits |
| Surgical robots / AR-MR platforms (SyngAR™) | Class III | Full evidence; may require TGA CA unless CE/FDA available |
| High-frequency electrosurgical devices | Class IIb/III | IEC 60601-2-2 tests mandatory |
| Blood glucose meters & strips | Class IIb | ISO 15197 performance + electrical safety |
| Single-use serum preparation device | Class IIa/IIb | Sterilization validation essential |
12. Advantages of the Australia Market
- Accepts EU/FDA approvals → fast entry
- ARTG validity is indefinite (while compliant)
- Mature and transparent regulatory system
- Harmonized with EU MDR/GHTF
- Strong demand for imported high-tech devices