Using Assessments from Comparable Overseas Regulators for Medical Devices – TGA Reliance Pathway

Overview of the Reliance Pathway

The TGA recognises that rigorous assessments conducted by certain comparable overseas regulators provide high-confidence evidence of a medical device’s safety, quality, and performance. Sponsors can submit evidence from these regulators to support their Australian conformity assessment or ARTG inclusion application, with the TGA conducting a more focused review on Australia-specific requirements (e.g., labelling, adverse event reporting obligations, and Essential Principles alignment). This approach reduces regulatory burden and accelerates market access without compromising protection of public health. Source: Using assessments from comparable overseas regulators - TGA

Eligible Overseas Regulators and Evidence

The TGA currently accepts assessments from:

• European Union: Certificates issued under the EU Medical Device Regulation (MDR) or, during transition, under the Medical Devices Directive (MDD)/Active Implantable Medical Devices Directive (AIMDD) by notified bodies.
• United States: Premarket Approval (PMA) or 510(k) clearance by the FDA for higher-risk devices.
• Medical Device Single Audit Program (MDSAP): MDSAP audit reports and certifications from recognised auditing organisations.
• Other Comparable Bodies: Assessments from regulators with demonstrated equivalence (e.g., Health Canada, UK MHRA in certain cases).

Accepted evidence typically includes full technical documentation reviews, QMS audits (ISO 13485), and clinical evaluation reports.

Application Process Using Reliance

1. Select Appropriate Pathway: Determine if the device qualifies for TGA reliance based on the overseas assessment scope and device classification.
2. Prepare Submission: Include the overseas certificate/report, summary of differences (if any) between overseas and Australian requirements, and Australian-specific documentation (e.g., local labelling, RMP where applicable).
3. Lodge Application: Submit via TGA eBusiness Services, clearly indicating reliance on overseas assessment.
4. TGA Review: The TGA focuses on:
   • Confirmation that overseas evidence covers the Australian intended use.
   • Compliance with Australian-specific Essential Principles.
   • Post-market obligations and vigilance alignment.
   • Any gaps requiring additional data.

Timelines are generally shorter than full TGA assessments.

Limitations and Conditions

• Reliance does not apply to all device types or classes; novel or high-risk devices may require additional TGA scrutiny.
• Sponsors remain responsible for ensuring ongoing compliance with Australian requirements post-inclusion.
• Changes to the device or overseas certification may trigger re-assessment.
• The TGA retains the right to request full documentation or conduct its own audits if concerns arise.

Benefits and Practical Considerations

This pathway significantly reduces duplication for devices already approved by stringent regulators, particularly beneficial for multinational manufacturers. Sponsors should:

• Ensure overseas assessment fully aligns with the Australian intended purpose.
• Maintain traceability between overseas and Australian documentation.
• Prepare for potential requests for supplementary Australian-specific information.

Detailed eligible regulators, accepted evidence types, submission templates, review focus areas, and examples of successful reliance applications are provided in the official TGA guidance on using assessments from comparable overseas regulators for medical devices. Source: Using assessments from comparable overseas regulators - TGA

The reliance mechanism supports efficient global harmonisation while safeguarding Australian public health standards.