Document ID: chunk:federal_register_of_legislation:F2024C00866:clause:1_1:p4
Version: federal_register_of_legislation:F2024C00866
Segment Type: clause
Provision Reference: sch 1 cl 1 (pt 4/8)
Character Range: 19798–23312

device, including instructions for assembly;
                              (x) any cleaning requirements for the device;
                              (xi) information about the replacement of the consumable components of the device during its expected lifetime, including the size and type of battery;
                              (xii) either the expiry date for the device or the expected lifetime of the device, indicated as duration of use after the first use or the number of actuations before being discarded;
                              (xiii) any precautions a patient or user should take if there are risks associated with the disposal of the device, including instructions on how to dispose of the device or its parts, or how to recycle used batteries
   8                     all of the following matters:
                           (a) a therapeutic vaping device must be labelled with information that is:
                              (i) in English; and
                              (ii) clearly legible; and
                              (iii) printed in a manner that is durable; and
                              (iv) in a text colour that is matte grey or matte black, unless required by an applicable standard to be another colour; and
                              (v) in a text colour that contrasts with the colour of the therapeutic vaping device;
                           (b) the label on the therapeutic vaping device must be matte white or matte grey, unless required by an applicable standard to be another colour;
                           (c) the label must contain the following information on the device itself:
                              (i) the sponsor's name;
                              (ii) the device name, brand name and model;
                              (iii) the batch code, lot number or serial number that identifies the kind of medical device;
                              (iv) the warning statement "Risk of fire or explosion. Replace only with the same size and type of battery";
                           (d) the label must contain the following information on the device itself, or on the packaging of the device if it is impracticable or inappropriate to be on the device itself:
                              (i) the address of the sponsor;
                              (ii) the name and address of the manufacturer;
                           (e) the information required by paragraphs (c) and (d) must be displayed in a text size of at least 3 mm
   9                     all of the following matters:
                           (a) a therapeutic vaping device accessory must be labelled with information that is:
                              (i) in English; and
                              (ii) clearly legible; and
                              (iii) printed in a manner that is durable; and
                              (iv) in a text colour that is matte grey or matte black, unless required by an applicable standard to be another colour; and
                              (v) in a text colour that contrasts with the colour of the therapeutic vaping device;
                           (b) the label on the therapeutic vaping device accessory must be matte white, matte grey or matte black, unless required by an applicable standard to be another colour;
                           (c) the label must contain the following information on the vaping device accessory itself:
                              (i) the device name and model;