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Determinations for Australian conformity assessment bodies

30 June 2021
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Description

These guidelines assist Australian corporations seeking to apply for an Australian conformity assessment body (CAB) determination for medical devices (including IVDs) by the Therapeutic Goods Administration (TGA).

  • About these guidelines
  • Eligibility for an Australian CAB determination
  • Application requirements
  • Assessment requirements
  • Certification-related activities
  • Requirements for Australian conformity assessment bodies
  • Scope of a determination
  • Conformity assessment procedures
  • Medical devices
  • Application and determination process
  • Assessment Program Cycle
  • Pre-application meetings
  • How to apply
  • How to fill in the application form
  • Fees and charges
  • Assessment process
  • The determination decision
  • What to expect once an initial determination is made
  • Further information

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