Medical Device Definition
A medical device in Australia means the following:
(a) any instrument, apparatus, appliance, software, implant, reagent, material or other article (whether used alone or in combination, and including the software necessary for its proper application) intended, by the person under whose name it is or is to be supplied, to be used for human beings for the purpose of one or more of the following
(i) diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation of disease;
(ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or disability;
(iii) investigation, replacement or modification of the anatomy or of a physiological or pathological process or state;
(iv) control or support of conception;
(v) in vitro examination of a specimen derived from the human body for a specific medical purpose;
and that does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in its function by such means; or
(aa) any instrument, apparatus, appliance, software, implant, reagent, material or other article specified under subsection (2A); or
(ab) any instrument, apparatus, appliance, software, implant, reagent, material or other article that is included in a class of instruments, apparatus, appliances, software, implants, reagents, materials or other articles specified under subsection (2B); or
(b) an accessory to an instrument, apparatus, appliance, software, implant, reagent, material or other article covered by paragraph (a), (aa) or
(ab); or
(c) a system or procedure pack.
Medical Device Classification System
International Classification |
Risk Level |
Examples |
Class I |
Low risk |
Surgical retractors
Tongue depressors |
Class I - supplied sterile |
Low to Medium |
Sterile surgical gloves |
Class I - with a measuring function |
Medicine cup with specific units of measurement |
Class IIa |
Dental drills; ultrasound machines; digital or infrared thermometers |
Class IIb |
Medium to High |
Surgical lasers
Diagnostic X-ray |
Class III |
High |
Prosthetic heart valves
Absorbable surgical sutures
Hip prostheses (for example, replacement of hip joint)
Pacemakers |