Australia Therapeutic Goods (Medical Devices) Regulations 2002 sch1-1: Essential principle 1: design and produce the device so that, used as intended by suitably trained users, it does not compromise the patient's condition or anyone's safety, and its risks are acceptable against the benefit

What does sch1-1 require?

Every device must be designed and made so that, when used on a patient in the conditions and for the purposes the manufacturer intends (and, where relevant, by a user with the right knowledge and training), it does not endanger the patient's clinical state or the safety and health of the user or others. Whatever risks remain must be acceptable when weighed against the intended benefit and consistent with a high level of health and safety protection. This principle is the anchor of the benefit and risk determination that the clinical evaluation procedures must demonstrate (regulation 3.11).