Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:4:p14
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 4 (pt 14/20)
Character Range: 574437–582168

days of receiving the request:
       (c) the kit contains 2 or more reusable surgical instruments and the only other therapeutic goods (if any) in the kit are either or both of the following:                                                                                                                                                                                                                                   (i) whether the device complies with the essential principles;
       (i) one or more implantable medical devices;                                                                                                                                                                                                                                                                                                                                                 (ii) whether the conformity assessment procedures (if any) have been applied to the device;
       (ii) one or more Class I, Class IIa, Class IIb or Class III medical devices; and                                                                                                                                                                                                                                                                                                             (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) each of the medical devices in the kit is included in the Register                                                                                                                                                                                                                                                                                                                       (d) The manufacturer of the device must, at all times, have available sufficient information to substantiate that the conformity assessment procedures (if any) have been applied to the device.
                                                                                                                                                                                                                                                                                                                                                                                                    (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, take measurements of, 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 of a kind mentioned in subsection 41MP(2) or 41MPA(2) of the Act to the Secretary within the following periods:
                                                                                                                                                                                                                                                                                                                                                                                                    (i) if the information relates to an event or other occurrence that represents a serious threat to public health—48 hours after the manufacturer or sponsor becomes aware of the event or occurrence;
                                                                                                                                                                                                                                                                                                                                                                                                    (ii) if the information relates to an event or other occurrence that led to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person—10 days after the manufacturer or sponsor becomes aware of the event or occurrence;
                                                                                                                                                                                                                                                                                                                                                                                                    (iii) if the information relates to an event or other occurrence a recurrence of which might lead to the death, or a serious deterioration in the state of health, of a patient, a user of the device, or another person—30 days after the