Applying for Australian Conformity Assessment Body Determination for Medical Devices – TGA Guidance

Purpose of CAB Determination

An Australian Conformity Assessment Body (CAB) determination is a TGA assessment confirming that a conformity assessment body (typically the manufacturer's notified body or internal QMS certifier) meets Australian regulatory requirements equivalent to those for TGA designation. This determination allows the CAB's certificates (e.g., ISO 13485, EU type examination) to be accepted as evidence for TGA conformity assessment certification, facilitating ARTG inclusion for higher-risk devices (Class IIa and above). Source: Applying for Australian Conformity Assessment Body determination - TGA

Eligibility Criteria

• The CAB must hold valid accreditation or designation for the relevant conformity assessment procedures (e.g., ISO 13485 certification body or EU notified body under relevant directives/regulations).
• The CAB must demonstrate equivalence to TGA requirements, including impartiality, competence, and procedures aligned with Australian regulations.
• Manufacturers applying must use the CAB for their device’s conformity assessment and provide supporting evidence.

Application Process

1. Pre-Application

   • Verify the CAB's scope covers the device's classification and procedures.
   • Collect CAB documentation (accreditation certificate, scope, audit reports).

2. Submission

   • Submit via TGA eBusiness Services portal.
   • Complete the specific CAB determination application form.
   • Upload required evidence.

3. Required Evidence

   • CAB accreditation/ designation certificate and scope.
   • Recent audit reports and findings.
   • Procedures demonstrating compliance with Australian requirements (e.g., adverse event reporting, post-market obligations).
   • Evidence of competence (personnel qualifications, training records).
   • Impartiality and conflict-of-interest policies.

4. Fees and Timelines

   • Specific fee for CAB determination (separate from device certification fees).
   • TGA aims to process within targeted timeframes (typically 60–120 working days, depending on complexity).
   • Clock stops for requests for further information.

5. Assessment and Outcome

   • TGA reviews for equivalence and compliance.
   • Successful determination results in TGA listing the CAB as acceptable for specified procedures.
   • Determination is time-limited and subject to ongoing monitoring.

Post-Determination Obligations

• Notify TGA of changes to CAB status or scope.
• CAB must maintain compliance and undergo periodic re-assessment.
• Manufacturer must use the determined CAB consistently for ongoing certification.

This determination streamlines acceptance of international conformity evidence while ensuring alignment with Australian standards. Detailed forms, evidence checklists, fee information, and examples are included in the official TGA guidance on applying for Australian Conformity Assessment Body determination for medical devices. Source: Applying for Australian Conformity Assessment Body determination - TGA

The guidance supports efficient regulatory pathways for manufacturers leveraging accredited bodies.