6

6 Application, saving and transitional provisions

(1) This section applies to articles in items 13 to 16 of the table in Schedule 1 that, immediately before the commencement of the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025, were included in the Register as a kind of medical device. (2) Items 13 to 16 of the table in Schedule 1 do not apply to the medical devices mentioned in subsection (1) until the earlier of: (a) the date on which the goods become registered goods or listed goods; and (b) 1 January 2031. (3) Despite subsection (2), the articles mentioned in subsection (1) may be dealt with as if items 13 to 16 of the table in Schedule 1 apply from 1 January 2026, including for the purposes of the following: (a) an application for the registration or listing of the therapeutic goods; (b) any applicable provisions in Part 3-2 of the Act in relation to applications for the registration or listing of therapeutic goods.

Schedule 1—Articles that are not medical devices

Note: See section 5.

<table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr><td colspan="2" style="border-top:1.5pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Articles that are not medical devices</span></p></td></tr><tr><td style="width:13.24%; border-top:0.75pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 1</span></p></td><td style="width:86.76%; border-top:0.75pt solid #000000; border-bottom:1pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Column 2</span></p></td></tr><tr><td style="width:13.24%; border-top:1pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Item</span></p></td><td style="width:86.76%; border-top:1pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><span>Articles or classes of articles</span></p></td></tr></thead><tbody><tr><td style="width:13.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>1</span></p></td><td style="width:86.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>articles incorporating tissues, cells or substances of human origin, other than medical devices incorporating stable derivatives of either human blood or human plasma, that act on, or are likely to act on, the human body in a way that is ancillary to the device</span></p></td></tr><tr><td style="width:13.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>2</span></p></td><td style="width:86.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>articles incorporating viable tissues, cells or substances of animal origin</span></p></td></tr><tr><td style="width:13.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>3</span></p></td><td style="width:86.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>articles that are intended to administer a medicine in such a way that the medicine and the article form a single integral product which is intended exclusively for use in the given combination and that are not reusable (may be multi</span><span>‑</span><span>dose)</span></p></td></tr><tr><td style="width:13.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="color:#313131; background-color:#ffffff">4</span></p></td><td style="width:86.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>chemical oxygen generators</span></p></td></tr><tr><td style="width:13.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="color:#313131; background-color:#ffffff">5</span></p></td><td style="width:86.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>hospital grade disinfectants or household grade disinfectants that are claimed to be sterilants, fungicides, sporicides, tuberculocides or virucides</span></p></td></tr><tr><td style="width:13.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="color:#313131; background-color:#ffffff">6</span></p></td><td style="width:86.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="color:#313131; background-color:#ffffff">in-vivo imaging agents injected, ingested, or otherwise instilled into the body</span></p></td></tr><tr><td style="width:13.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="color:#313131; background-color:#ffffff">7</span></p></td><td style="width:86.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>riboflavin products instilled into the eye that are used in the treatment of disorders of the eye which cause structural changes within the cornea</span></p><p class="notetext" style="margin-left:35.45pt; text-indent:-35.45pt"><span>Note:</span><span style="width:15.45pt; text-indent:0pt; display:inline-block"> </span><span>These riboflavin products are used with UV-A light illumination in order to achieve an alteration of the normal chemical process of crosslinking of collagen, with the purpose of making the cornea stronger and more stable.</span></p></td></tr><tr><td style="width:13.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="color:#313131; background-color:#ffffff">8</span></p></td><td style="width:86.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>topical applications intended to remove or neutralise chemical, biological or radiological agents used in chemical, biological or radiological warfare</span></p></td></tr><tr><td style="width:13.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="color:#313131; background-color:#ffffff">9</span></p></td><td style="width:86.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>unmedicated preparations for topical use for protecting against, or providing relief from, nappy rash symptoms by acting only as a barrier for the skin (whether or not the preparations also have a moisturising action)</span></p></td></tr><tr><td style="width:13.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="color:#313131; background-color:#ffffff">10</span></p></td><td style="width:86.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>therapeutic vaping devices or therapeutic vaping device accessories in a therapeutic vaping pack</span></p></td></tr><tr><td style="width:13.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="color:#313131; background-color:#ffffff">11</span></p></td><td style="width:86.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>therapeutic vaping substance accessories</span></p></td></tr><tr><td style="width:13.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="color:#313131; background-color:#ffffff">12</span></p></td><td style="width:86.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>vaping devices that are pre-filled with a therapeutic vaping substance that form a single integral product which is intended exclusively for use in the given combination and that are not reusable (may be multi-dose)</span></p></td></tr><tr><td style="width:13.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="color:#313131; background-color:#ffffff">13</span></p></td><td style="width:86.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>toothpastes and other dentifrices that achieve their principal intended action through having an effect by chemical or pharmacological means</span></p></td></tr><tr><td style="width:13.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="color:#313131; background-color:#ffffff">14</span></p></td><td style="width:86.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>head or body lice treatments that achieve their principal intended action through having an effect by chemical or pharmacological means</span></p></td></tr><tr><td style="width:13.24%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="color:#313131; background-color:#ffffff">15</span></p></td><td style="width:86.76%; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>moisturisers and emollients that achieve their principal intended action through having an effect by chemical, metabolic or pharmacological means</span></p></td></tr><tr><td style="width:13.24%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span style="color:#313131; background-color:#ffffff">16</span></p></td><td style="width:86.76%; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="Tabletext"><span>weight loss treatments that are ingested into the body and that affect absorption of calories in the gastrointestinal system by metabolic means</span></p></td></tr></tbody></table>