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).
Contents
- 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
Supporting documents
Determinations for Australian conformity assessment bodies
[PDF, 401.48 KB]
Determinations for Australian conformity assessment bodies
[Word, 622.87 KB]