Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:4:p12
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 4 (pt 12/20)
Character Range: 558351–568664

following:
                                                                                                                                                                                                                                                                                                                                                                                                    (a) the name and address of the sponsor;
                                                                                                                                                                                                                                                                                                                                                                                                    (b) the name and address of the manufacturer of that kind of medical device;
                                                                                                                                                                                                                                                                                                                                                                                                    (c) the device nomenclature system code of that kind of medical device;
                                                                                                                                                                                                                                                                                                                                                                                                    (d) the medical device classification of that kind of medical device;
                                                                                                                                                                                                                                                                                                                                                                                                    (e) the unique product identifier given to each medical device of that kind.
2.15   Medical device that is clinical decision support system software that is:                                                                                                                                                                                                                                                                                                                    (a) The device must comply with the essential principles.
       (a) intended by its manufacturer to be for the sole purpose of providing or supporting a recommendation to a health professional about preventing, diagnosing, curing or alleviating a disease, ailment, defect or injury in persons; and                                                                                                                                                    (b) The manufacturer of the device must apply the appropriate conformity assessment procedures at all times.
       (b) not intended by its manufacturer to directly process or analyse a medical image or signal from another medical device; and                                                                                                                                                                                                                                                               (c) The manufacturer of the device must, on request by the Secretary, provide the following information within 20 working days of receiving the request:
       (c) not intended by its manufacturer to replace the clinical judgement of a health professional in relation to making a clinical diagnosis or decision about the treatment of patients                                                                                                                                                                                                       (i) whether the device complies with the essential principles;
                                                                                                                                                                                                                                                                                                                                                                                                    (ii) whether the conformity assessment procedures have been applied to the device;
                                                                                                                                                                                                                                                                                                                                                                                                    (iii) whether the device complies with every requirement (if any) relating to advertising applicable under Part 5‑1 of the Act or the Therapeutic Goods Regulations 1990.
                                                                                                                                                                                                                                                                                                                                                                                                    (d) The manufacturer of the device must, at all times, have available:
                                                                                                                                                                                                                                                                                                                                                                                                    (i) sufficient information to substantiate that the conformity assessment procedures have been applied to the device; or
                                                                                                                                                                                                                                                                                                                                                                                                    (ii) information relating to changes to the device and quality management system.
                                                                                                                                                                                                                                                                                                                                                                                                    (e) The manufacturer of the device must allow an authorised person to do any of the following:
                                                                                                                                                                                                                                                                                                                                                                                                    (i) enter, at any reasonable time, any premises at which the manufacturer manufactures the device;
                                                                                                                                                                                                                                                                                                                                                                                                    (ii) inspect the premises and the device, and examine, conduct tests on or require tests to be conducted on the device or anything on those premises that relates to the device;
                                                                                                                                                                                                                                                                                                                                                                                                    (iii) make any still or moving image or any recording of those premises or anything on those premises.
                                                                                                                                                                                                                                                                                                                                                                                                    (f) If asked to do so by an authorised person, the manufacturer of the device must give to the person any documents relating to the device that the person requires and allow the person to copy the documents.
                                                                                                                                                                                                                                                                                                                                                                                                    (g) The Secretary must not have directed that the supply of the device be stopped or should cease because the supply compromises public health and safety.
                                                                                                                                                                                                                                                                                                                                                                                                    (h) The manufacturer or sponsor of the device must provide information