About system and procedure packs
System and procedure packs are combinations of medical devices supplied together for specific medical procedures. Examples include surgical kits and wound care packs.
These packs must be included in the Australian Register of Therapeutic Goods (ARTG) before supply. You are responsible for ensuring your packs meet quality, safety and performance standards.
We assess applications, monitor safety, and enforce regulations to protect public health in Australia.
From 1 July 2026, medical devices are required to have a UDI (Unique Device Identification). Starting with higher risk (class IIb and III) devices, UDI will help us -consumers, health professionals, industry and other stakeholders – easily access device information.
You must meet certain obligations to legally supply therapeutic goods in Australia. This section contains guidance and information specific to medical devices. You may also have to meet obligations that apply to all medical devices and all products.
