Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:4:p2
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 4 (pt 2/20)
Character Range: 479432–482293

by a medical practitioner to be appropriate treatment for the importer or family member (unless the device is carried by the importer as a passenger on a ship or an aeroplane)
1.1A  Medical devices that are therapeutic vaping devices, therapeutic vaping device accessories, therapeutic cannabis vaping devices or therapeutic cannabis vaping device accessories, imported into Australia by a person (the first person) on board a ship or aircraft, if:
      (a) the medical devices are for use in the treatment of the first person or one or more other persons on board the ship or aircraft who are under the care of the first person; and
      (b) the importation of the medical devices meets the requirements of paragraph 5(2)(b) or subregulation 5A(2) of the Customs (Prohibited Imports) Regulations 1956
1.2   Medical device that is exported from Australia and:
      (a) is not intended for commercial supply; and
      (b) does not contain a substance the export of which is prohibited under the Customs Act 1901; and
      (c) is not intended for use for experimental purposes on humans
1.3   Samples of a medical device that is imported into Australia, exported from Australia, or manufactured or supplied in Australia for any of the following purposes (other than for supply for use in or on a human being):
      (a) submission to a regulatory authority;
      (b) subjection to developmental or quality control procedures;
      (c) examination, demonstration or display, with notice included to the effect that the device is not available for general supply unless it is included in the Register;
      (d) subjection to analysis, evaluation or laboratory testing procedures;
      (e) use in the manufacture of goods including therapeutic goods;
      (f) testing performed on a specimen taken from a cadaver (except to assess whether a part of the cadaver is suitable for transfusion or transplantation)
1.3A  Medical device that is an oxygen administration hood for use in a hyperbaric chamber for hyperbaric oxygen therapy
1.3B  Medical device that is:
      (a) manufactured by a health professional or by a person acting under the written instructions of a health professional; and
      (b) manufactured from other medical devices that are included in the Register and are covered by item 3A, 3B, 3C, 3D or 3E of the table in Schedule 1 to the Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020, as that instrument is in force from time to time
1.4   Medical device that:
      (a) is imported into Australia solely for the purpose of being exported from Australia; and
      (b) while 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