Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:4:p19
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 4 (pt 19/20)
Character Range: 609326–615967

Secretary, give a copy of the records to the Secretary within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary's request is made); and
                                                                                                                                                                                                                                                                                                                                                                                                    (iii) if the Secretary requests information about the supply of the device during a specified period—give the information to the Secretary within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary's request is made) and in a form approved in writing by the Secretary.
                                                                                                                                                                                                                                                                                                                                                                                                    (j) The sponsor must provide information of a kind mentioned in subsection 41MP(2) or 41MPA(2) of the Act relating to the device 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 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 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 sponsor becomes aware of the event or occurrence;
                                                                                                                                                                                                                                                                                                                                                                                                    (iv) in any other case—60 days after the sponsor becomes aware of the information.
2.18   Medical device imported into Australia, if the medical device is a component or article imported for use in the manufacture of:                                                                                                                                                                                                                                                              (a) The sponsor must give the Secretary a notice (the sponsor notice), in a form approved in writing by the Secretary, stating that the device is for use in the manufacture, in accordance with the requirements of the Act, of a therapeutic vaping device, a therapeutic vaping device accessory or a therapeutic cannabis vaping good by a manufacturer that holds all relevant licences or approvals (however described) required under the law of the State or Territory in which the manufacture is to occur.
       (a) a therapeutic vaping device; or                                                                                                                                                                                                                                                                                                                                                          (b) The sponsor notice must be given before importing the device.
       (b) a therapeutic vaping device accessory; or                                                                                                                                                                                                                                                                                                                                                (ba) The sponsor must:
       (c) a therapeutic cannabis vaping good                                                                                                                                                                                                                                                                                                                                                       (i) if requested by the Secretary, give the Secretary a reasonable number of samples of the device; and
                                                                                                                                                                                                                                                                                                                                                                                                    (ii) do so within the period requested by the Secretary (which must be at least 5 working days starting on the day on which the Secretary's request is