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Australian conformity assessment bodies

Medical devices and IVDs

30 June 2021

Australian corporations can apply to become an Australian conformity assessment body (Australian CAB) for medical devices from 1 July 2021.

The determination of an Australian CAB requires demonstrated competency and recognition for undertaking medical device product assessments and quality management system auditing.

The Therapeutic Goods Administration (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.

Background

The Expert Review of Medicines and Medical Devices Regulation made recommendations aimed at streamlining the TGA's processes for including medical devices in the ARTG and to improve timely access to new medical devices by Australian consumers.

Amendments made to the therapeutic goods legislation enables the TGA to authorise Australian corporations to perform the assessments required by the conformity assessments procedures for medical devices by making an Australian CAB Determination.

Through these amendments, the TGA will consider alignment with European requirements for a Notified Body and Auditing Organisation requirements for the Medical Device Single Audit Program and will apply them to the assessment of an Australian CAB. The TGA will also utilise best practice documents and standards that are promoted by the International Medical Devices Regulators Forum (IMDRF). This is to ensure that any determination made and any ongoing management of Australian CABs aligns with international practices.

Eligibility and guidelines

To apply to become an Australian CAB the applicant must demonstrate:

  • they are registered with the Australian Securities and Investments Commission (ASIC) as an Australian Corporation and hold a current Australian Company Number (ACN)
  • the competence, independence and impartiality of personnel proposed to be involved in the organisation's certification-related activities in Australia
  • how they will perform certification-related activities consistent with the Australian regulatory framework

Refer to the Guidelines for Organisations applying for an Australian conformity assessment body determination to ensure you meet the eligibility criteria. These outline:

  • the eligibility information
  • the requirements for certification-related activities
  • the requirements for Australian CABs
  • how a determination is scoped
  • the application and determination process
  • the determination decision
  • what to expect once a determination is made

Application forms

Online application form

Apply for an Australian conformity assessment body determination.

Application for Determination of Australian conformity assessment bodies

Downloadable forms

Certificate under subregulation 4A.6(3) of the Therapeutic Goods (Medical Devices) Regulations

Privacy

General privacy information relating to applications for Australian CAB determinations

Register of Australian conformity assessment bodies

Australian corporations granted an Australian CAB Determination will be included in the Register of Australian conformity assessment bodies.