Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:4:p15
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 4 (pt 15/20)
Character Range: 581947–587792

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 person under whose name the device is or is to be supplied must keep records relating to the supply of the device by or on behalf of the person.
                                                                                                                                                                                                                                                                                                                                                                                                    (j) The person under whose name the device is or is to be supplied must, on request by the Secretary, provide to the Secretary those records within 20 working days of receiving the request or a longer period agreed to by the Secretary.
2.17   Medical device, if:                                                                                                                                                                                                                                                                                                                                                                          (a) The sponsor must give the sponsor notice to the Secretary in a form approved in writing by the Secretary.
       (a) the device is:                                                                                                                                                                                                                                                                                                                                                                           (b) The sponsor notice must be given as follows:
       (i) a therapeutic vaping device; or                                                                                                                                                                                                                                                                                                                                                          (i) for a device imported into Australia on or after 1 March 2024—before the device is imported;
       (ii) a therapeutic vaping device accessory; and                                                                                                                                                                                                                                                                                                                                              (ii) for a device imported into Australia before 1 March 2024—before the earlier of the time the device is supplied to the ultimate consumer and the end of the period of 2 months beginning on the day Schedule 1 to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024 commences;
       (b) the sponsor has given the Secretary a notice (the sponsor notice) stating that:                                                                                                                                                                                                                                                                                                          (iii) for a device manufactured in Australia on or after 1 March 2024—before the device is first supplied in Australia;
       (i) the device is intended, by the person under whose name the device is or is to be supplied, only to administer or contain a therapeutic vaping substance whose only indications are use for smoking cessation or the management of nicotine dependence; and                                                                                                                               (iv) for a device manufactured in Australia before 1 March 2024—before the earlier of the time the device is supplied to the ultimate consumer and the end of the period of 2 months beginning on the day Schedule 1 to the Therapeutic Goods Legislation Amendment (Vaping Reforms) Regulations 2024 commences.
       (ii) the device complies with the essential principles, or is imported or supplied (as the case may be) with the consent of the Secretary under section 41MA or 41MAA of the Act; and                                                                                                                                                                                                        (c) The sponsor holds information or evidence to support:
       (c) the sponsor notice has not been withdrawn by the sponsor by a notice (the withdrawal notice) given to the Secretary, with the withdrawal