1. Certification Overview
The Therapeutic Goods Administration (TAG) is the Australian regulatory body responsible for pharmaceuticals, medical devices, biological products, blood, tissues, advanced therapies, and other therapeutic products. All pharmaceuticals and medical devices imported, exported, or sold in Australia must be registered or listed in the Australian Pharmaceuticals Database and must obtain a TGA Certificate of Conformity Assessment in advance.
Australia classifies medical devices into four classes based on their risk level: Class I, Class IIa, Class IIb, and Class III.
High-risk medical devices require a Certificate of Conformity. As a Certificate of Conformity, conformity data issued by specific overseas regulatory agencies and evaluation bodies, not just those issued by the TGA, may be used.
2. Regulatory Bodies & Basic Information
| Regulatory Agencies | TGA (Therapeutic Goods Administration) |
| Testing Agency | 1. There are no designated laboratories required to undergo testing for TGA certification. 2. The TGA requires test reports from accredited laboratories whose test results are reliable. The requirements for such laboratories are as follows: 1) Laboratories accredited by NATA (National Association of Testing Authorities) 2) Laboratories accredited under ISO 17025 3) Laboratories for CE certification 4) FDA-approved laboratories |
| Lead time / Price | Varies by product |
| Agent | Local agent required |
3. Medical Device Classification
| Class | Risk | Example | |
|---|---|---|---|
| Class I | Low risk | • Manual Surgical & Examination Tools: Surgical scalpels & forceps, Tongue depressors • General Assistive Furniture: Manual wheelchairs, Hospital beds • Non-invasive Consumables: Non-sterile bandages, Examination gloves |  Examination gloves |
| Class IIa | Low to Moderate risk | • Routine Monitoring & Diagnostic Tools: Electronic thermometers, Electronic blood pressure monitors, Hearing aids • Short-term Invasive Materials: Dental drills & fillings, Contact lenses • Ultrasound Imaging Equipment: Ultrasound diagnostic machines |  Dental drills & fillings |
| Class IIb | Moderate risk | • Active Critical Devices: Infusion pumps, Surgical lasers, Diagnostic X-ray sources • Long-term Support Systems: Mechanical ventilators, Blood bags, Condoms • Orthopedic Fixation Devices: Bone fixation plates & screws |  |
| Class III | High risk | • Cardiovascular & Neurological Implants: Implantable pacemakers, Coronary stents, Artificial heart valves • Permanent Joint Replacements: Total hip/knee replacements • Injectable Materials & Special Grafts: Hyaluronic acid dermal fillers, Absorbable surgical sutures |  Hyaluronic acid dermal fillers |
4. Certification Process
- Check eligibility for medical devices
- Understanding Agent Liabilities and Ensuring Access to Information
- Check device exemption status
- Create an online account
- Decision on whether to apply for priority review
- Check the device’s grade and category
- Submission of manufacturer’s supporting documents
- Apply for a device on ARTG and pay the application fee
- Result Receipt (Approval, Selection for Audit, Rejection)
5. Required Documents
| Administrative & Legal Documents | • Local Representative Appointment • ARTG Inclusion Application Form • Australian Declaration of Conformity (DoC) • Application Fee & Annual Charge Receipt |
| Quality Management System Documents | • Overseas Evidence of Conformity Assessment • ISO 13485 Certification |
| Technical & Safety Dossier | • Essential Principles Checklist • Technical File (STED) • Full Test Reports • Clinical Evidence Report (CER) • English Labeling & Instruction Manual |
6. Validity Period and Maintenance
- ARTG License: No expiration date
- Maintenance Condition: Payment of Annual Charge