Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:4:p1
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 4 (pt 1/20)
Character Range: 476896–479678

Schedule 4—Exempt devices
(regulation 7.1)

Part 1—Exempt devices—general

Item  Kinds of medical devices
1.1   Medical device that is imported into Australia for use in the treatment of the importer, or a member of the importer's immediate family, or for use in the in vitro examination of a specimen obtained from the importer or a member of the importer's immediate family, if:
      (a) the device does not contain a substance the importation of which is prohibited under the Customs Act 1901; and
      (ab) the device is not a device referred to in item 1.1A; and
      (b) in the case of:
      (i) a device, other than an IVD medical device, that is manufactured using tissues, tissue derivatives, cells or substances of animal origin that have been rendered non‑viable, or tissues, cells or substances of bacterial or recombinant origin; or
      (ii) a device, other than an IVD medical device, that incorporates, or is intended to incorporate, as an integral part, a stable derivative of human blood or blood plasma—
       the device is the subject of an approval under section 41HB of the Act; and
      (c) in the case of a Class 4 IVD medical device, Class III medical device, Class 3 IVD medical device, Class IIb medical device, Class 2 IVD medical device or Class IIa medical device:
      (i) the quantity imported in one importation is not more than the amount required to give 3 months use of the device according to:
      (A) the treating medical practitioner's directions; or
      (B) the manufacturer's instructions for use of the device; or
      (C) directions, recommendations or advice of a Commonwealth, State or Territory authority that has functions in relation to, or that is responsible for or deals with, health matters; and
      (ii) the total quantity imported in a 12 month period is not more than the amount required to give 15 months use of the device according to:
      (A) the treating medical practitioner's directions; or
      (B) the manufacturer's instructions for use of the device; or
      (C) directions, recommendations or advice of a Commonwealth, State or Territory authority that has functions in relation to, or that is responsible for or deals with, health matters; and
      (d) in the case of a device that is subject to Schedule 4 or Schedule 8 to the current Poisons Standard, or a device that incorporates, or is intended to incorporate, as an integral part, a substance that is subject to either of those Schedules—the device, or substance, is acknowledged in writing 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