The government is now operating in accordance with the Guidance on Caretaker Conventions, pending the outcome of the 2025 federal election.
The regulatory framework for medical devices including IVD medical devices spans the life of the device and includes:
- pre-market assessment: conformity assessment
- market authorisation: inclusion in the ARTG
- post-market monitoring: continuing compliance with all regulatory, safety and performance requirements and standards.
For details go to Overview of medical devices and IVD regulation.
For details on how IVDs are classified go to Classifying IVDs.