The classification system uses a set of classification rules based on the manufacturers intended use, the level of risk and the degree of invasiveness in the human body.

Products in Australia are classified into one of the following from lowest to highest risk:

• Class I
• Class I Measuring or Sterile
• Class IIa
• Class IIb
• Class III
• AIMD (Active Implantable Medical Devices)

The Australian classification system is similar to the European classification guidelines and the vast majority of devices previously registered in Europe will carry the same classification in Australia. There are proposed changes in the Australian Classification to further align with the European Classification.

Australia Specific Cases