Active Medical Devices
Regulatory requirements for active medical devices in Australia — devices that rely on an energy source other than gravity or the human body.
Software & AI
Regulatory requirements for software as a medical device (SaMD) and AI-based medical devices in Australia, including the November 2024 changes.
IVD Medical Devices
Specific regulatory requirements for in vitro diagnostic medical devices in Australia, beyond their classification.
Implantable Devices
Regulatory requirements specific to implantable medical devices in Australia, including classification, post-market obligations, and patient implant cards.
Devices Incorporating a Medicine
Regulatory requirements for medical devices that incorporate a medicine as an integral part, including classification, boundary issues, and the applicable regulatory pathway.
Animal, Microbial and Recombinant Origin
Requirements for medical devices containing or derived from animal tissues, cells, microbial substances, or recombinant materials.
Systems and Procedure Packs
What systems and procedure packs are, how they are classified, and the regulatory requirements for sponsors who assemble them.
Custom-Made Devices
What custom-made medical devices are under Australian law, when the exemption applies, and what obligations remain for manufacturers and sponsors.
Single-Use Devices
Regulatory requirements for single-use medical devices in Australia, including labelling obligations and the position on reprocessing.
Export-Only Devices
The regulatory pathway for medical devices manufactured in Australia for export only, and the conditions under which a device can be exported without ARTG inclusion.
Personalised and Patient-Matched Devices
The regulatory position for personalised, patient-matched, and 3D-printed medical devices in Australia — when ARTG inclusion is required.