The TGA allows applicants to use evidence and assessments from Comparable Overseas Regulators (CORs) to support inclusion in the ARTG. This pathway can reduce duplication of regulatory review. Where appropriate, the TGA may rely on assessments from trusted regulators instead of repeating a full independent review.
Recognized Regulators
European Union (Notified Bodies) | United States (FDA) | Canada (Health Canada) | Japan (PMDA/MHLW)
Step 1: Confirm eligibility for COR pathway
The device must:
- Be approved by a recognized COR
- Have comparable intended use and design
- Have sufficient supporting documentation available
Step 2: Determine appropriate application pathway
The COR pathway is typically used for:
- Inclusion in ARTG using existing approvals
- Devices already approved in major markets
It does not replace standard TGA requirements, but supports them.
Step 3: Prepare submission leveraging overseas evidence
Include:
- Evidence of approval (e.g., CE certificate, FDA clearance/approval)
- Assessment reports (where available)
- Technical documentation aligned with TGA requirements
- Explanation of equivalence between overseas approval and TGA submission
Step 4: Submit ARTG application using COR evidence
The sponsor submits the application through TGA systems, referencing:
- Overseas approvals
- Supporting assessment documentation
Step 5: TGA performs abridged or targeted review
TGA may:
- Rely on overseas assessments
- Conduct a targeted review instead of full reassessment
- Request additional information if needed
Step 6: TGA decision
- If acceptable → Device included in ARTG
- If gaps identified → Additional data requested or application rejected
Final Step
Market access with ongoing obligations
- Device can be supplied in Australia
- Must maintain a valid overseas approval (where relied upon), compliance with TGA requirements including post-market obligations
We Turn Existing Approvals Into Australian Market Access. Qaralogic has helped MedTech companies leverage their FDA, Health Canada, and CE Mark approvals to support TGA submissions through the Comparable Overseas Regulator pathway cutting redundant review and accelerating ARTG inclusion.