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
Requirements for Australian conformity assessment bodies
Scope of a determination
Conformity assessment procedures
Application and determination process
Assessment Program Cycle
How to apply
How to fill in the application form
Fees and charges
The determination decision
What to expect once an initial determination is made
The Department of Health and Aged Care acknowledges First Nations peoples as the Traditional Owners of Country throughout Australia, and their continuing connection to land, sea and community. We pay our respects to them and their cultures, and to all Elders both past and present.