Document ID: chunk:federal_register_of_legislation:F2024L01673:clause:1_2
Version: federal_register_of_legislation:F2024L01673
Segment Type: clause
Provision Reference: sch 1 cl 2
Character Range: 2348–3970

2  Part 2 of Schedule 4 (cell at table item 2.17, column headed "Kinds of medical devices")
Repeal the cell, substitute:

Medical device, if:
(a) the device is:
(i) a therapeutic vaping device; or
(ii) a therapeutic vaping device accessory; and
(b) the sponsor has given the Secretary a notice (the sponsor notice) stating that:
(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
(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(c) the sponsor notice has not been withdrawn by the sponsor by a notice (the withdrawal notice) given to the Secretary, with the withdrawal taking effect:
(i) on the day specified in the withdrawal notice, being a day that is later than the day that notice is given to the Secretary; or
(ii) otherwise—on the day the withdrawal notice is given; and
(d) the device is not the subject of a determination, by the Secretary and published on the Department's website, that the supply of the device be stopped or should cease because:
(i) the Secretary is satisfied that the supply compromises public health and safety; or
(ii) the Secretary is satisfied that the device does not comply with the essential principles; or
(iii) the sponsor has failed to comply with a request by the Secretary under paragraph (e) of the column headed "Conditions" of this item