6Excluded goods when used, advertised or presented for supply in a particular way

6 Excluded goods when used, advertised or presented for supply in a particular way

For subsection 7AA(2) of the Act, the goods specified in Schedule 2, when used, advertised, or presented for supply in a way specified in that Schedule are excluded goods for the purposes of the Act.

7 Application, saving and transitional provisions

Items 14 and 15 of the table in Schedule 1 and items 5 and 10 of the table in Schedule 2, as in force immediately before the commencement of the Therapeutic Goods (Excluded Goods) Amendment (Sunscreen) Determination 2024, continue to apply to goods covered by those items only where: (a) the goods were excluded goods under those items on 30 June 2024; and (b) paragraph (b) in column 2 of each of those items, as in force immediately before the commencement of the Therapeutic Goods (Excluded Goods) Amendment (Sunscreen) Determination 2024, applies to the goods; and (c) the goods are imported, manufactured or supplied before 1 July 2029.

Schedule 1 Specified goods

(section 5)

<table cellspacing="0" cellpadding="0" style="width:421.9pt; border-collapse:collapse"><thead><tr style="height:16.1pt"><td colspan="3" style="width:411.1pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span style="font-weight:bold">Specified goods</span></p></td></tr><tr style="height:16.1pt"><td colspan="2" style="width:51.3pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span style="font-weight:bold">Column 1</span></p><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span style="font-weight:bold">Item</span></p></td><td style="width:349pt; border-top:0.75pt solid #000000; border-bottom:1.5pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span style="font-weight:bold">Column 2</span></p><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span style="font-weight:bold">Specified goods</span></p></td></tr></thead><tbody><tr style="height:16.1pt"><td style="width:44.25pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>1</span></p></td><td colspan="2" style="width:356.05pt; border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>adhesive removers and non-medicated skin cleansers relating to colostomy and ileostomy</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>1A</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>anatomical models that are intended by the manufacturer to be used for educational or record-keeping purposes</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>2</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="line-height:115%; font-size:10pt"><span>antiperspirant preparations that derive their antiperspirant properties from inorganic salts of aluminium, zinc or zirconium only</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>2A</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="line-height:115%; font-size:10pt"><span>articles that are non-sterile personal protective equipment or safety apparel other than articles specified in item 1 of Schedule 1 to the </span><span style="font-style:italic">Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>2B</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>cosmetic finishing components for orthoses and prostheses</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>2C</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>craniofacial prostheses that are:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>spectacle-retained; or</span></p><p style="margin-left:18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; display:inline-block"> </span><span>adhesive-retained</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>3</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>dental bleaches and dental whiteners</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>3AA</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>dental impression trays</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>3A</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>detergents and soaps for laundering or general cleaning use, other than detergents and soaps that are disinfectants within the meaning of the Regulations</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>4</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>devices for measuring alcohol content in body fluids or exhaled air</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>5</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>disinfectant and sterilant gases</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>6</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>drinking water purification and treatment equipment</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>7</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>ear candles</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>7AA</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>ear moulds that are intended by the manufacturer to anchor hearing aids</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>7A</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>fluoridated reticulated drinking water</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>8</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>hair bleaches, hair dyes, hair-colorants and hair-perming preparations</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>9</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>household and personal aids, or furniture and utensils, for people with disabilities</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>10</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>incontinence pads, mattress overlays and mattress protectors</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>10A</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>medicament trays that are intended by the manufacturer to hold medicaments</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>11</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>menstrual pads other than tampons and menstrual cups</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>11A</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>mouthguards intended by the manufacturer to be used to protect teeth from external forces including, but not limited to, mouthguards used in contact sports</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>11B</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>ocular prostheses intended by the manufacturer to be used for cosmetic purposes</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>11C</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>physical impressions of anatomy, and models cast from such impressions</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>12</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>sanitation, environmental control and environmental detoxification equipment (including films and coatings), other than articles specified in item 3 of Schedule 1 to the </span><span style="font-style:italic">Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020</span></p><p class="notetext" style="margin-top:4pt; margin-left:39.9pt; text-indent:-39.9pt; font-size:10pt"><span>Note:</span><span style="width:17.68pt; text-indent:0pt; display:inline-block"> </span><span>Sanitation, environmental control and environmental detoxification equipment does not include disinfectants within the meaning of the Regulations.</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>12A</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>spectacle frames</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>13</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>topical preparations applied to the nails to harden, or deter the biting of, nails</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>products containing sunscreen that are intended for application to the lips, and that:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>do not contain any substance included in Schedule 2, 3, 4 or 8 to the Poisons Standard; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>are a secondary sunscreen product; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(c)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>have any protection factor or equivalent category description stated on the product’s label in accordance with clause 5 of AS/NZS 2604:2021; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(d)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>if the product’s label states a protection factor—have a label that meets the requirements of clauses 6.1 and 6.3 of AS/NZS 2604:2021; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(e)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>meet the performance requirements for a broad-spectrum product set out in clause 5.3 and Table</span><span> </span><span>1 in clause 4.2 of AS/NZS 2604:2021</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14A</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software that is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to be used by a consumer for the self-management of an existing disease, condition, ailment or defect that is not a serious disease or serious condition, ailment or defect; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to be used:</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:11.26pt; text-indent:0pt; display:inline-block"> </span><span>in clinical practice; or</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:8.48pt; text-indent:0pt; display:inline-block"> </span><span>in relation to a serious disease or serious condition, ailment or defect; or</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>for the purpose of diagnosis, treatment, or making a specific recommendation or decision about the treatment, of a disease, condition, ailment or defect that is not a serious disease or serious condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14B</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software, or a combination of software and non-invasive hardware, that is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to be used by a consumer to promote or facilitate general health or wellness by measuring or monitoring (through non-invasive means) a physical parameter, such as movement, sleep, heart rate, heart rhythm, temperature, blood pressure or oxygen saturation; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to be used:</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:11.26pt; text-indent:0pt; display:inline-block"> </span><span>in clinical practice; or</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:8.48pt; text-indent:0pt; display:inline-block"> </span><span>for the purpose of diagnosis, screening, prevention, monitoring, prediction, prognosis, alleviation, treatment, or making a recommendation or decision about the treatment, of a serious disease or a serious condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14C</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software that is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to be used by a consumer to improve general health or wellness by coaching, or encouraging behavioural change, in relation to personal or environmental factors, such as weight, exercise, sun exposure or dietary intake; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to be used:</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:11.26pt; text-indent:0pt; display:inline-block"> </span><span>in clinical practice or to provide information to the consumer that would generally be accepted to require the interpretation of a health professional; or</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:8.48pt; text-indent:0pt; display:inline-block"> </span><span>for the purpose of diagnosis, prognosis, or making a decision about the treatment, of a disease, condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14D</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software that is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to be used as a patient reported outcome measures (PROMs) questionnaire or patient survey; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to diagnose, screen for, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14E</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software that is a digital mental health tool (including a cognitive behaviour therapy tool) based on established clinical practice guidelines that are referenced and displayed in the software in a manner that is reviewable by the user</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14F</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; page-break-after:avoid; line-height:115%; font-size:10pt"><span>software that is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; page-break-after:avoid; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to enable communications, including the transmission of patient information, for the purposes of supporting the delivery of health services; and</span></p><p class="ListParagraph" style="text-indent:-18pt; page-break-after:avoid; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14G</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software that is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to be used for the administration or management of health processes or facilities (including financial records, claims, billing, appointments, operating theatre management, hospital bed management, schedules, business analytics, admissions, inventory and workflow); and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to be used for the purpose of diagnosis, screening, prevention, monitoring, prediction, prognosis, alleviation, treatment, or making a recommendation or decision about the treatment, of a disease, condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14H</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software that is intended by its manufacturer to be used for the sole purpose of storing or transmitting patient images</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14I</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:17.55pt; text-indent:-17.55pt; line-height:115%; font-size:10pt"><span>software that is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to be used for the sole purpose of providing alerts to health professionals in relation to patient care; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to:</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:11.26pt; text-indent:0pt; display:inline-block"> </span><span>replace the clinical judgement of a health professional; or</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:8.48pt; text-indent:0pt; display:inline-block"> </span><span>diagnose, screen for, prevent, alleviate, treat, or make a decision about the treatment of, a disease, condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14J</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:17.55pt; text-indent:-17.55pt; line-height:115%; font-size:10pt"><span>software that is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to be used for clinical workflow management; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14K</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software that is middleware and is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to connect or interface applications to an underlying operating system or another application, including by communicating or transmitting information; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to:</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:11.26pt; text-indent:0pt; display:inline-block"> </span><span>control medical devices; or</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:8.48pt; text-indent:0pt; display:inline-block"> </span><span>perform analysis, computation or logic that relates to the intended purpose of a medical device; or</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:5.7pt; text-indent:0pt; display:inline-block"> </span><span>be used for the purpose of diagnosis, screening, prevention, monitoring, prediction, prognosis, alleviation, treatment, or making a recommendation or decision about the treatment, of a disease, condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14L</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; margin-left:17.55pt; text-indent:-17.55pt; line-height:115%; font-size:10pt"><span>software that is a calculator and:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>either:</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:11.26pt; text-indent:0pt; display:inline-block"> </span><span>uses relevant published clinical standards or authoritative sources to make calculations; or</span></p><p class="ListParagraph" style="margin-left:56.7pt; text-indent:-20.7pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:8.48pt; text-indent:0pt; display:inline-block"> </span><span>displays calculations and outputs in a manner that may be validated by the user; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>is not intended by its manufacturer to control the administration of a calculated dosage</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14M</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software, or a combination of software and hardware, that is an electronic health record (however named or described) and is:</span></p><p style="margin-top:3pt; margin-left:38.95pt; text-indent:-21.25pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:10.15pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to be used in clinical practice by healthcare providers to collect, use, disclose and otherwise manage patient clinical data within or between healthcare facilities; and</span></p><p style="margin-top:3pt; margin-left:38.95pt; text-indent:-21.25pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:9.59pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to diagnose, screen for, prevent, monitor, predict, make a prognosis of, alleviate, treat, or make a recommendation or decision about the treatment of, a disease, condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14N</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software that is data analytics and is:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>intended by its manufacturer to be used for the collection and analysis of class, group or population data; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>not intended by its manufacturer to be used for the purpose of diagnosis, prevention, monitoring, prediction, prognosis, treatment or alleviation, of a disease, condition, ailment or defect in relation to individuals</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>14O</span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>software that is a laboratory information management system (however named or described) and is not intended by its manufacturer to:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>manipulate information or data to change, or generate new, diagnostic outputs (other than automating simple calculations or generating report comments); or</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>prevent, monitor, predict, make a prognosis of, treat or alleviate a disease, condition, ailment or defect</span></p></td></tr><tr style="height:16.1pt"><td style="width:44.25pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>15</span></p><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span></span></p></td><td colspan="2" style="width:356.05pt; border-top:0.75pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p style="margin-top:3pt; line-height:115%; font-size:10pt"><span>tinted bases and foundations, such as liquids, pastes or powders, that contain sunscreen, and that:</span></p><p class="ListParagraph" style="margin-top:3pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>do not contain any substance included in Schedule 2, 3, 4 or 8 to the Poisons Standard; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>are a secondary sunscreen product; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(c)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>have any protection factor or equivalent category description stated on the product’s label in accordance with clause 5 of AS/NZS 2604:2021; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(d)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>if the product’s label states a protection factor—have a label that meets the requirements of clauses 6.1 and 6.3 of AS/NZS 2604:2021; and</span></p><p class="ListParagraph" style="text-indent:-18pt; line-height:115%; font-size:10pt"><span>(e)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>meet the performance requirements for a broad-spectrum product set out in clause 5.3 and Table 1 in clause 4.2 of AS/NZS 2604:2021</span></p></td></tr><tr style="height:0pt"><td style="width:55.05pt"></td><td style="width:7.05pt"></td><td style="width:359.8pt"></td></tr></tbody></table>