How Classification Works
How Australia's risk-based medical device classification system works, what factors determine a device's class, and why getting it right matters.
Class I, IIa, IIb, III & AIMD
Detailed breakdown of each general medical device class in Australia — what they cover, examples, and key regulatory requirements for each class.
IVD Class 1, 2, 3 & 4
Australia's four-tier risk-based classification system for in vitro diagnostic medical devices, with examples and key requirements for each class.
Active & Software Devices
How active medical devices and software as a medical device (SaMD) are classified in Australia, including the specific classification rules and recent regulatory changes.
Reclassification Updates
Recent and upcoming reclassification changes affecting medical devices in Australia, including the AIMD to Class III transition and software device changes.