Australia Medical Device Registration
Therapeutic Goods Administration (TGA) approval timelines and requirements
Australia Medical Device Registration Overview
Australia medical device registration through TGA typically takes 0.5-1 months for Class I devices. The official TGA target is 0-1 weeks, but realistic timelines include preparation, documentation review, and potential questions from regulators.Australia uses a 5-class (I, IIa, IIb, III, AIMD) risk-based classification system. Foreign manufacturers must appoint a Australian Sponsor to register devices in Australia. TGA accepts MDSAP certification, which eliminates separate tga qms audits, 5-year certificate validity. Registration is valid for 5 years.
Australia uses a 5-class (I, IIa, IIb, III, AIMD) risk-based classification system.
Class I
Notification
• Fastest Class I globally
• Minimal documentation
Class IIa
Conformity Assessment
Accelerated with: EU CE Mark, FDA 510(k), MDSAP
• CE mark significantly reduces timeline
Class IIb
Enhanced Assessment
Accelerated with: EU CE Mark, FDA 510(k), MDSAP
• CE mark abridged assessment route available
Class III
Full Assessment
Accelerated with: EU CE Mark (30-50% faster), FDA 510(k), MDSAP
• CE mark abridged assessment significant advantage
Priority Review Pathway
Front-of-queue placement for novel devices addressing unmet needs
Existing approvals from other regulatory authorities can accelerate your Australia registration.
- Australian Sponsor (for foreign manufacturers)
- ARTG (Australian Register of Therapeutic Goods) listing
- Conformity assessment documentation
- MDSAP or TGA audit
5 years
Eliminates separate TGA QMS audits, 5-year certificate validity
Australia Medical Device Registration Process
Step-by-step TGA registration process. Total estimated timeline: 0.5-1 months.
Step 1: Pre-Submission Preparation
1-3 monthsGather technical documentation, quality management system (QMS) records, and clinical data required by TGA. Appoint a Australian Sponsor.
Step 2: Application Submission
1-2 weeksSubmit complete registration dossier to TGA including device description, risk analysis, and testing reports.
Step 3: Administrative Review
2-4 weeksTGA reviews application for completeness. May request additional documents or clarifications.
Step 4: Technical Evaluation
0-1 weeksIn-depth technical assessment of device safety and performance. TGA may issue questions.
Step 5: Registration Approval
1-2 weeksUpon successful review, TGA issues Australia market authorization certificate.
Timelines are estimates based on 2024-2025 data. Last updated: 2025-12-01.