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Per section 41BD of the Therapeutic Goods Act (1989), a Medical Device is defined as something that meets any of the following criteria: Diagnosis, monitoring, prediction, prognosis, treatment or alleviation of disease, injury or disability Prevention of disease Compensation for an injury or disability Investigation, replacement or modification of the anatomy or of a physiological or pathological process or state Control or support of conception Is an accessory to a medical device (something specifically intended to be used together with a medical device to enable that device to function as intended) Note these changes apply to medical device software only and are not relevant to IVD medical device software