Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:4:p3
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 4 (pt 3/20)
Character Range: 482053–489370

in Australia, remains subject to customs control under the Customs Act 1901; and
      (c) is not subject to any of the activities mentioned in section 41BG of the Act by a manufacturer in Australia
1.4A  Medical device that is prescription spectacle lenses (whether or not supplied with a mounting) if the lenses (disregarding any lens treatments) are intended, by the person under whose name the device is or is to be supplied, to be used only to provide refractive corrections
1.7   Patient‑matched medical device

Part 2—Exempt devices—exemption subject to conditions

Item   Kinds of medical devices                                                                                                                                                                                                                                                                                                                                                                     Conditions
2.1    Medical device that is imported into Australia, if:                                                                                                                                                                                                                                                                                                                                          (a) The supply of the device must be in accordance with the relevant notification, approval, authorisation or medical practitioner's direction.
       (a) the device is not a device referred to in item 2.17; and                                                                                                                                                                                                                                                                                                                                 (b) The device must be kept in a warehouse or properly secured area under the control of the sponsor.
       (b) the device is held under the direct control of the sponsor, until the device is:                                                                                                                                                                                                                                                                                                         (c) For a device that is a therapeutic cannabis vaping good—the sponsor has, before importing the device, given the Secretary a notice, in a form approved in writing by the Secretary, stating that:
       (i) the subject of a notification under item 2.3; or                                                                                                                                                                                                                                                                                                                                         (i) 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
       (ii) approved for importation into Australia under section 41HB or 41HD of the Act; or                                                                                                                                                                                                                                                                                                       (ii) the sponsor holds information or evidence to support the statement made for the purposes of subparagraph (i).
       (iii) authorised for supply under section 41HC of the Act; or                                                                                                                                                                                                                                                                                                                                (d) The sponsor must:
       (iv) used for a Category A patient, within the meaning of regulation 7.2; or                                                                                                                                                                                                                                                                                                                 (i) keep records relating to the source and supply of the device; and
       (v) exported from Australia                                                                                                                                                                                                                                                                                                                                                                  (iii) if requested by the Secretary, give the records to the Secretary.
2.2    Medical device affected by section 41FH of the Act that is imported into Australia and is held under the direct control of the sponsor until a decision is made under section 41FI of the Act in relation to the device                                                                                                                                                                      (a) The sponsor must:
                                                                                                                                                                                                                                                                                                                                                                                                    (i) keep records relating to the source of the device; and
                                                                                                                                                                                                                                                                                                                                                                                                    (ii) if requested by the Secretary, give the records to the Secretary; and
                                                                                                                                                                                                                                                                                                                                                                                                    (iii) before importing the device, have lodged an application under section 41FC of the Act for the device to be included in the Register.
                                                                                                                                                                                                                                                                                                                                                                                                    (b) If the application is not successful, the device must be destroyed or returned to the consignor