What is an Australian CAB?

Australian Conformity Assessment Body (CAB) is a corporation accredited by the Therapeutic Goods Administration (TGA), Australia’s health agency regulating Therapeutic goods, including medical devices. Australian CABs are located in Australia and are accredited testing bodies that carry out conformity assessments and issue conformity assessment certifications. They carry out appropriate audits and reviews of a manufacturer’s procedures. The certificates can be used by an Australian sponsor to support the application for the inclusion of medical devices in the Australian Register of Therapeutic Goods (ARTG).

Who can Apply for Australian CABs?

TGA has been accepting applications from Australian corporations for an Australian CAB determination since July 01, 2021.  The company must be registered as an Australian corporation with the Australian Securities and Investments Commission (ASIC) and hold a valid Australian Company Number (ACN).

What are the Application Requirements for Australian Conformity Assessment Bodies?

Necessary Requirements for an Applicant

1. Employ personnel with the required technical, scientific, and clinical competence

4. Maintain independence and impartiality

2. Facilities to carry out assessments for issuing conformity assessment certificate

5. Ability to respond to avoid conflict of interests concerning manufacturers

3. Undertake post-certification activities

6. Effective QMS and general liability insurance


Also, the Australian CAB framework aims to align with European Union (EU) requirements for notified bodies as defined in Annex VII of the European Medical Devices Regulation 2017/745 (EU MDR) and In Vitro Diagnostic Regulation 2017/746 (EU IVDR) that came into force on May 25, 2017.

The requirements also aim to align with the Medical Device Single Audit Program’s (MDSAPs) criteria for auditing organizations and implement recommendations from the International Medical Device Regulators Forum (IMDRF), Good Regulatory Review Practices (GRRP) working group (Requirements for Regulatory Authority recognition of CABs conducting medical device Regulatory reviews and supporting documents).

Why Pre-Application Meeting?

Before applying, it is recommended that your company arrange a pre-application meeting to discuss the requirements for determination, the assessment process, and the obligations that must be fulfilled by employees of the Australian CAB. To request a pre-application meeting with the TGA, please email AUCAB@health.gov.au.

What is the Assessment Process?

Australian CAB determinations are made and renewed on a four-year cycle. The TGA will base its assessment program on the processes agreed upon by Regulatory Authorities who are participating in the Medical Device Single Audit Program (MDSAP) and the development of the Medical Device Single Review Program (MDSRP).

The Australian CAB determination assessment program is divided into an Initial determination Assessment followed by a Surveillance Assessment and a Re-determination Assessment.

  • Initial Determination Assessment: includes an Application review and Documentation request.
  • After the assessment, the Review and Recommendation group gives initial determination decisions, and if necessary, there can be witnessing of Quality Management Services (QMS) audits and assessment of product reviews.
  • Surveillance Assessment (head office): Includes stage 2 assessment in the head office followed by witnessing of QMS audits and assessment of product reviews, as necessary.
  • Re-determination Assessment (head office): Includes stage 2 assessment in the head office followed by documentation review by re-recognition assessment, witnessing of QMS audits, and assessment of product reviews. The review and recommendation group gives the final re-determination decision.

Pre-Assessment: Completeness and Assessment Plan

Stage 1 Assessment ----> Stage 2 Assessment (head office)

Documentation Review

Critical Locations, as necessary


The TGA will carry out an assessment of, at least, the following: procedures to verify the requirements for Australian CABs; the implementation of the procedures by the company personnel, and the effectiveness of the company’s QMS. The assessment activities may include offsite, onsite, or remote, including head office locations. In addition, critical locations are sites or facilities where critical functions are carried out by, or on behalf of, the Australian CAB.  

The determination of an Australian CAB requires demonstrated competency and recognition for undertaking medical device product assessments and quality management system auditing. The TGA remains responsible for including medical devices in the Australian Register of Therapeutic Goods (ARTG). The TGA will continue to provide product assessments and quality management assessments when required by legislation or at the request of a manufacturer.

The amendments done in the regulations made by TGA will ease the manufacturers who earlier could only rely on conformity assessment certification by the TGA for inclusion in the ARTG for medical devices (including devices that contain medicines or materials of animal, microbial, recombinant, or human origin; and Class 4 in vitro diagnostic (IVD) medical devices) as TGA will now accept conformity assessment documents issued by an Australian CAB.    

Are you looking forward to launching your medical device in the Australian market? Would you like to gain more insight into the Australian medical device market? Reach out to an expert like Freyr!