Classification of medical devices

The medical devices regulatory framework has a classification system.

Manufacturers must meet regulatory evidence requirements in line with the class of their device.

Guidance for sponsors

Manufacturers are responsible for classifying their medical devices.

You must enter the correct class when you apply to include a device in the ARTG.

We cannot refund application fees for applications entered with the wrong class. More information is available at: Refunds.

Guidance for manufacturers

The intended purpose of your device is critical to determining the correct class. Identical devices can have different classes if they are intended to be used in different ways. For example:

• in different parts of the body,
• by health professionals or consumers, or
• with other devices.

The intended purpose of your medical device is the purpose you state in your:

• instructions for use
• labels
• advertising materials
• technical documents that describe your device’s mechanism of action

To classify your device:

• apply the classification Principles
  and
• apply the classification Rules
  and
• consider the relevant definitions in the MD Regulations Dictionary.

The Australian classification rules can be different from overseas classification rules.

Guidance on classification of selected types of devices