Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:4:p13
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 4 (pt 13/20)
Character Range: 567643–574896

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                                                                                                                                                                                                                                                                                                                                                                                                    (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 manufacturer or sponsor becomes aware of the event or occurrence;
                                                                                                                                                                                                                                                                                                                                                                                                    (iv) in any other case—60 days after the manufacturer or sponsor becomes aware of the information.
                                                                                                                                                                                                                                                                                                                                                                                                    (i) The sponsor of the device must notify the Secretary, using a form approved in writing by the Secretary:
                                                                                                                                                                                                                                                                                                                                                                                                    (i) as far as it is reasonably practicable, of any supply of the device by or on behalf of the sponsor that occurred before 25 February 2021, being a notification within 60 working days (or such longer period as is agreed to by the Secretary) of that day; and
                                                                                                                                                                                                                                                                                                                                                                                                    (ii) of any importation or supply of the device by or on behalf of the sponsor on or after 25 February 2021, being a notification within 20 working days (or such longer period as is agreed to by the Secretary) of the importation or supply.
2.16   Medical device that is a surgical loan kit, where:                                                                                                                                                                                                                                                                                                                                           (a) The device must comply with the essential principles.
       (a) the kit is intended by its manufacturer to be supplied to hospitals in Australia; and                                                                                                                                                                                                                                                                                                    (b) The manufacturer of the device must apply the appropriate conformity assessment procedures (if any) at all times.
       (b) the kit is intended by its manufacturer to be used in a surgical procedure; 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) 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