Systems that are medical devices

A system is two or more goods (whether packaged together or not) that the manufacturer intends to be:

• connected
• used together, or
• combined.

to achieve a specific medical purpose.

However, a system is:

• not a single item
• not a collection of miscellaneous items that the manufacturer does not intend to be used together for a specific purpose
• not bulk packs of one or more items
• not a procedure pack, though a procedure pack can include a system in it.

Examples of medical device systems

• knee-joint replacement system
• orthopaedic drill system
• a patient-monitoring system with a monitor, power cable, and backup power supply
• a system to monitor recovery after a knee injury with:
  • a mobile phone app
  • online database in the cloud (connected through Wi-Fi), and
  • an ankle bracelet (connected through Bluetooth) that has an accelerometer to monitor lower-leg movement
• a blood-glucose monitoring kit with a blood-glucose meter, test strips, controls, lancets, and a lancing device.

Guidance for sponsors

You must include a system that is a medical device in the Australian Register of Therapeutic Goods (ARTG) in the same way as all other medical devices. 

Your application to include the system in the ARTG as a single entry must have:

• regulatory evidence
• a Global Medical Device Nomenclature (GMDN) code that covers the system.

The instructions for use (IFU) of the device must also describe how the system components work together (Essential Principles 13.4(18) and 13.4(16)).

Supplying components separately from the system

You must make separate applications when:

• you supply components separately from the system (for example, accessories and consumables), and
• those components are medical devices that are a different kind of medical device than the system.

Example

An Automated External Defibrillator (AED) that is supplied with electrodes and batteries is included in the ARTG as a system. Replacement batteries and electrodes are included in the ARTG separately from the AED.

Many IVD systems use test reagents and accessories that are higher class medical devices than the instrument they are used with. The reagents and accessories must be included in the ARTG separately from the instrument.

Guidance for manufacturers

Manufacturers of some systems can use a special regulatory pathway. See System or procedure packs.