Document ID: chunk:federal_register_of_legislation:F2025C00021:schedule:4:p8
Version: federal_register_of_legislation:F2025C00021
Segment Type: schedule
Provision Reference: sch 4 (pt 8/20)
Character Range: 523657–533235

must not be prohibited under the Customs (Prohibited Imports) Regulations 1956.
                                                                                                                                                                                                                                                                                                                                                                                                    (c) The quantity of the device imported must be consistent with the quantity required for the treatment of passengers and members of the crew travelling on the ship or aircraft.
                                                                                                                                                                                                                                                                                                                                                                                                    (d) The device must not be supplied to, or used in the treatment of, a person other than a passenger or a member of the crew travelling on the ship or aircraft.
                                                                                                                                                                                                                                                                                                                                                                                                    (e) The device must not be removed from the ship or aircraft while the ship or aircraft is in Australia.
                                                                                                                                                                                                                                                                                                                                                                                                    (f) The master of the ship or the pilot of the aircraft must be responsible for the control and custody of the device while the ship or aircraft is in Australia.
                                                                                                                                                                                                                                                                                                                                                                                                    (g) The person mentioned in paragraph (f) must:
                                                                                                                                                                                                                                                                                                                                                                                                    (i) carry a list, in English, of the quantity and nature of the device imported; and
                                                                                                                                                                                                                                                                                                                                                                                                    (ii) keep a record of the use of the device while the ship or aircraft is in Australia; and
                                                                                                                                                                                                                                                                                                                                                                                                    (iii) produce the list or record for inspection at the request of a customs officer or a person who is an authorised person for the purposes of section 41FN of the Act.
2.9    Medical device that is a system or procedure pack under section 41BF of the Act that:                                                                                                                                                                                                                                                                                                        (a) The device must be imported, supplied or manufactured on or before 31 December 2010.
       (a) is imported, supplied or manufactured by or on behalf of the Commonwealth; and                                                                                                                                                                                                                                                                                                           (b) The importation, supply or manufacture of the device must be approved in writing by the Secretary.
       (b) is certified by the Secretary to be emergency supplies for stockpiling for use in the event of a public health emergency.                                                                                                                                                                                                                                                                (c) The use and supply of the device must be in accordance with the written approval of the Secretary.
                                                                                                                                                                                                                                                                                                                                                                                                    (d) Records in relation to the importation, supply or manufacture of the device must be kept in accordance with the directions of the Secretary.
                                                                                                                                                                                                                                                                                                                                                                                                    (e) The disposal of any unused device must be in accordance with the directions of the Secretary.
2.10   Medical device that is a Class 1, Class 2 or Class 3 in‑house IVD medical device                                                                                                                                                                                                                                                                                                             (a) The device must comply with the essential principles.
                                                                                                                                                                                                                                                                                                                                                                                                    (b) The manufacturer of the device must apply the appropriate conformity assessment procedures at all times.
                                                                                                                                                                                                                                                                                                                                                                                                    (d) The manufacturer of the device must, on request by the Secretary, provide the following information within 20 working days of receiving the request:
                                                                                                                                                                                                                                                                                                                                                                                                    (i) whether the device complies with the essential principles;
                                                                                                                                                                                                                                                                                                                                                                                                    (ii) whether the conformity assessment procedures have been applied to the device;
                                                                                                                                                                                                                                                                                                                                                                                                    (iii) whether the device complies with every requirement (if any) relating to advertising applicable under Part 5‑1 of the