Commonwealth legislation

Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023

In ForceCTH

Jurisdiction

Commonwealth

Collection

legislative instrument

Plain English Summary

8/10 complexity

This Order establishes a technical medical-device standard for therapeutic vaping devices and accessories (limited to products intended only for smoking cessation or nicotine-dependence management) that were previously excluded. It requires manufacturers and sponsors to meet multiple quality, risk-management, testing and labelling rules (ISO/IEC/AS standards, battery testing, toxicological assessment, design/packaging and plain‑colour/label restrictions). Manufacturers, importers and sponsors bear the cost of certification, testing, and compliant labelling/packaging; compliance determines whether devices are treated as meeting the essential principles.

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Deep Dive

6,950 words · generated 15/06/2026

What it does

This instrument, the Therapeutic Goods (Medical Device Standard,Therapeutic Vaping Devices) Order 2023, made under subsection 41CB(1) of the Therapeutic Goods Act 1989 (see s 3), declares a bespoke medical device standard for a narrowly-defined subset of vaping products and prescribes detailed manufacturing, design, labelling, packaging, testing and conformity requirements. Mechanically, the principal effects in the instrument are these.

Application: it captures therapeutic vaping devices and accessories that were formerly excluded under item 16 of Schedule 1 to the Therapeutic Goods (Excluded Goods) Determination 2018, but only where the device is intended by the supplier to administer, or contain, a therapeutic vaping substance whose sole indication is smoking cessation or management of nicotine dependence (s 6). In short, devices with other indications are outside this Order; the device must be intended solely for smoking cessation or nicotine dependence management.
Creation of standard and conformity effect: s 7(1) declares that the matters set out in Schedule 1 constitute a medical device standard for these therapeutic vaping devices and accessories. s 7(2) provides that devices complying with that standard are to be treated as complying with all parts of the essential principles in Schedule 1 to the Therapeutic Goods (Medical Devices) Regulations 2002 (MD Regulations). That is a legal mechanism whereby conformity with this Order is given presumptive equivalence to meeting the MD Regulations' essential principles.
Transitional saving: s 8 preserves application of the "former order" (the 2023 Order as in force immediately before the 2024 amendment) for devices imported or manufactured before 1 March 2025 and supplied before 1 July 2025; s 8 ceases on 1 July 2025. The instrument therefore contains limited temporal grandfathering for existing stock.

Current sections

Direct links to the current provisions in Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023.

Name

1 Name

This instrument is the Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023.

Authority

3 Authority

This instrument is made under subsection 41CB(1) of the Therapeutic Goods Act 1989.

Definitions

4 Definitions

Note 1: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a) essential principles;
(b) medical device standard;
(c) therapeutic goods.

In this instrument:

accredited certification body means a body that is accredited to undertake certification for compliance with IEC 60086-1, IEC 62133-1 or IEC 62133-2, by an International Electrotechnical Commission accepted national certification body.

Act means the Therapeutic Goods Act 1989.

AS/NZS 3820 means Australian/New Zealand Standard AS/NZS 3820, Essential safety requirements for electronic equipment, published jointly by, or on behalf of, Standards Australia and Standards New Zealand, as in force or existing from time to time.

Note: AS/NZS 3820 is published at www.standards.org.au.

AS/NZS 4417.1 means Australian/New Zealand Standard AS/NZS 4417.1, Marking of electronic products to indicate compliance with regulations, published by, or on behalf of, Standards Australia and Standards New Zealand, as in force or existing from time to time.

Note: AS/NZS 4417.1 is published at www.standards.org.au.

IAF accredited organisation means an organisation that is accredited to undertake certification for compliance with ISO 13485 (or both) by an accreditation body member that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum, Inc., otherwise known as the IAF MLA.

IEC 60086-1 means IEC 60086-1, Primary Batteries – Part 1: General, published by the International Electrotechnical Commission, as in force or existing from time to time.

Note: IEC 60086 is published at www.webstore.iec.ch.

IEC 62133-1 means IEC 62133-1, Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications – Part 1: Nickel systems, published by the International Electrotechnical Commission, as in force or existing from time to time.

Note: IEC 62133-1 is published at www.webstore.iec.ch.

IEC 62133-2 means IEC 62133-2, Secondary cells and batteries containing alkaline or other non-acid electrolytes – Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications – Part 2: Lithium systems, published by the International Electrotechnical Commission, as in force or existing from time to time.

Note: IEC 62133-2 is published at www.webstore.iec.ch.

instructions for use has the same meaning as in the MD Regulations.

ISO 13485 means International Standard ISO 13485, Medical devices—Quality management systems—Requirements for regulatory purposes, issued by the International Organization for Standardization, as in force or existing from time to time.

Note: ISO 13485 is published at www.iso.org.

ISO 14971 means International Standard ISO 14971, Medical devices – Application of risk management principles to medical devices, issued by the International Organization for Standardization, as in force or existing from time to time.

Note: ISO 14971 is published at www.iso.org.

ISO 17025 means International Standard ISO 17025, Testing and calibration laboratories, issued by the International Organization for Standardization, as in force or existing from time to time.

Note: ISO 17025 is published at www.iso.org.

ISO 17025 accredited laboratory means a laboratory that is accredited, by a member body of the International Laboratory Accreditation Cooperation, to operate in accordance with ISO 17025 to undertake certification for compliance with UN/DOT 38.3.

notified body means a body that:

(a) has been designated by a member state of the European Union, and notified to the European Commission; or
(b) has been approved or designated by the United Kingdom Medicines & Healthcare products Regulatory Agency;

to assess the conformity of medical devices.

MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.

TG Regulations means the Therapeutic Goods Regulations 1990.

text size means the height of the following:

(a) capital letters or lower case letters, including an ascender or descender;
(b) numbers or numerals;
(c) symbols.

therapeutic vaping device has the same meaning as in the MD Regulations.

therapeutic vaping device accessory has the same meaning as in the MD Regulations.

therapeutic vaping substance has the same meaning as in the TG Regulations.

UN/DOT 38.3 means section 38.3 of the United Nations document Recommendations on the Transport of Dangerous Goods: Manual of Tests and Criteria, established by the United Nations, as in force or existing from time to time.

Note: UN/DOT 38.3 applies to lithium cells and batteries, and contains criteria, test methods and procedures for the safe transportation of dangerous goods. UN/DOT 38.3 is published at www.unece.org.

venting means the emission of the battery or cell electrolyte as a liquid, droplets or vapour from a designed vent or through a seal intended to preclude rupture.

Application

6 Application

This instrument applies to therapeutic vaping devices or therapeutic vaping device accessories that: (a) were excluded under item 16 of the table in Schedule 1 to the Therapeutic Goods (Excluded Goods) Determination 2018, as in force immediately before the commencement of the Therapeutic Goods (Excluded Goods) Amendment (Vaping) Determination 2023; and (b) is intended by the person under whose name the device is or is to be supplied, only to administer, or contain, a therapeutic vaping substance for which the only indication is use for smoking cessation or the management of nicotine dependence.

Note: The Therapeutic Goods (Excluded Goods) Determination 2018 is a legislative instrument published on the Federal Register of Legislation at www.legislation.gov.au.

Medical device standard

7 Medical device standard

(1) The matters specified in Schedule 1 constitute a medical device standard for therapeutic vaping devices and therapeutic vaping device accessories. (2) Therapeutic vaping devices and therapeutic vaping device accessories that comply with the standard in subsection 7(1) are to be treated as complying with all parts of the essential principles in Schedule 1 to the MD Regulations.

8 Application, saving and transitional provisions

(1) In this section: former order means the Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023, as in force immediately before the commencement of the Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Amendment Order 2024. (2) Despite the amendments to the former order made by the Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Amendment Order 2024, the former order continues to apply in relation to therapeutic vaping devices and therapeutic vaping device accessories that are: (a) imported or manufactured before 1 March 2025; and (b) supplied before 1 July 2025. (3) This section ceases to apply on 1 July 2025.

Schedule 1—Medical device standard for therapeutic vaping devices and therapeutic vaping device accessories

Note: See section 7.

<table cellspacing="0" cellpadding="0" style="width:100%; border-collapse:collapse"><thead><tr style="height:2.85pt"><td colspan="2" style="border-top:1.5pt solid #000000; border-bottom:0.75pt solid #000000; padding-right:5.4pt; padding-left:5.4pt; vertical-align:top"><p class="TableHeading"><a id="_Hlk161917346"><span>Medical Device Standard</span></a></p></td></tr><tr style="height:2.85pt"><td style="width:12.8%; 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="TableHeading"><span>Column 1</span></p></td><td style="width:87.2%; 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="TableHeading"><span>Column 2</span></p></td></tr><tr style="height:2.85pt"><td style="width:12.8%; 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="TableHeading"><span>Item</span></p></td><td style="width:87.2%; 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="TableHeading"><span>Matters</span></p></td></tr></thead><tbody><tr style="height:1pt"><td style="width:12.8%; 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:87.2%; 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>all of the following matters:</span></p><p class="ListParagraph" style="margin-top:3pt; margin-left:19.25pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(a)</span><span style="width:6.75pt; text-indent:0pt; display:inline-block"> </span><span>ISO 13485 certification for the manufacture of the therapeutic vaping device or the therapeutic vaping device accessory, issued by one of the following:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>an IAF accredited organisation;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>a notified body;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>an auditing organisation recognised by Health Canada;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>an Australian conformity assessment body determined under the MD</span><span> </span><span>Regulations;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>compliance to ISO 13485 for the manufacture of the therapeutic vaping device or the therapeutic vaping device accessory</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; 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" style="margin-left:23.25pt; text-indent:-23.25pt"><span>2</span></p></td><td style="width:87.2%; 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="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>all of the following matters:</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>ISO 14971 compliance for the application of risk management to the therapeutic vaping device or the therapeutic vaping device accessory, including but not limited to the management of:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>hazards or risks relating to the toxicity of emissions from the therapeutic vaping device or the therapeutic vaping device accessory, for the expected lifetime of the device, as identified in a toxicological risk assessment; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>hazards or risks relating to the toxicity of the materials within the therapeutic vaping device or therapeutic vaping device accessory, and any residues or contaminants, for the expected lifetime of the device; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>hazards or risks relating to batteries (if applicable), including risk of fire or explosion; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>electrical hazards or risks; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(v)</span><span style="width:6.19pt; text-indent:0pt; display:inline-block"> </span><span>hazards or risks relating to the usability of the therapeutic vaping device or the therapeutic vaping device accessory; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(vi)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>hazards or risks relating to the reasonably foreseeable misuse of the therapeutic vaping device or the therapeutic vaping device accessory; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(vii)</span><span style="width:0.63pt; text-indent:0pt; display:inline-block"> </span><span>hazards or risks relating to the containment of a therapeutic vaping substance in, and the administration of a therapeutic vaping substance by, the therapeutic vaping device or the therapeutic vaping device accessory; and</span></p><p class="ListParagraph" style="margin-left:40.5pt; text-indent:-21.25pt; line-height:115%; font-size:10pt"><span>(viii)</span><span style="width:1.25pt; text-indent:0pt; display:inline-block"> </span><span>hazards or risks relating to heating of the therapeutic vaping device or therapeutic vaping device accessory;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>the manufacturer must establish and maintain a risk management file, which documents the risk assessment process for managing all hazards or risks associated with a therapeutic vaping device or a therapeutic vaping device accessory, including the hazards or risks mentioned in paragraph</span><span> </span><span>(a)</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; 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" style="margin-left:23.25pt; text-indent:-23.25pt"><span>3</span></p></td><td style="width:87.2%; 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="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>all of the following matters, as applicable to the therapeutic vaping device or the therapeutic vaping device accessory:</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>for a primary battery (other than a button battery)—IEC 60086-1 certification (as</span><span> </span><span>applicable) issued by an accredited certification body;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>for a secondary battery (other than a button battery) that is a lithium battery—both of the following:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>UN/DOT 38.3 certification, or declaration of conformity with UN/DOT 38.3, supported by independent test reports from an ISO 17025 accredited laboratory;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>IEC 62133-2 certification issued by an accredited certification body;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>for a secondary battery (other than a button battery) that is a nickel system battery—IEC 62133-1 certification issued by an accredited certification body;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>for a button battery—compliance with all of the following:</span></p><p class="ListParagraph" style="margin-left:41.25pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.56pt; text-indent:0pt; display:inline-block"> </span><span>the </span><span style="font-style:italic">Consumer Goods (Button/Coin Batteries) Information Standard 2020</span><span>;</span></p><p class="ListParagraph" style="margin-left:41.25pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.78pt; text-indent:0pt; display:inline-block"> </span><span>the </span><span style="font-style:italic">Consumer Goods (Button/Coin Batteries) Safety Standard 2020</span><span>;</span></p><p class="ListParagraph" style="margin-left:41.25pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:3pt; text-indent:0pt; display:inline-block"> </span><span>the </span><span style="font-style:italic">Consumer Goods (Products Containing Button/Coin Batteries) Safety Standard 2020</span><span>;</span></p><p class="ListParagraph" style="margin-left:41.25pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.56pt; text-indent:0pt; display:inline-block"> </span><span>the </span><span style="font-style:italic">Consumer Goods (Products Containing Button/Coin Batteries) Information Standard 2020</span></p><p class="ListParagraph" style="margin-top:3pt; margin-left:55pt; text-indent:-31.75pt; line-height:115%; font-size:9pt"><span>Note:</span><span style="width:11.75pt; text-indent:0pt; display:inline-block"> </span><span>These legislative instruments are published on the Federal Register of Legislation at www.legislation.gov.au</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; 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" style="margin-left:23.25pt; text-indent:-23.25pt"><span>4</span></p></td><td style="width:87.2%; 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="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>all of the following matters, as applicable to the therapeutic vaping device or the therapeutic vaping device accessory:</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>AS/NZS 3820 compliance with essential safety requirements for low voltage electrical equipment;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>AS/NZS 4417.1 compliance with marking of electrical products to indicate compliance with regulations</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; 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" style="margin-left:23.25pt; text-indent:-23.25pt"><span>5</span></p></td><td style="width:87.2%; 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="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>a therapeutic vaping device, and a therapeutic vaping device accessory as applicable, must be designed and constructed in a way that:</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>when operated in accordance with the instructions for use, the device provides the emitted mass or dose as specified and verified by the manufacturer; and</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>incorporates a reliable venting mechanism that channels the pressure wave in the direction where the harm is minimised; and</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>minimises the risk of inadvertent actuation; and</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>ensures that any external parts or accessible surfaces, other than the mouthpiece, of the device that may be held or grasped during use does not exceed 48°C during use; and</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>ensures that the external surface of the mouthpiece does not exceed 55°C during use; and</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(f)</span><span style="width:8.01pt; text-indent:0pt; display:inline-block"> </span><span>ensures that the device will withstand regular use, and foreseeable misuse or abuse, without breaking, leaking or failing in an unsafe manner; and</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(g)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>incorporates child-resistant features to prevent:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>the operation of the device by children; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>the accidental ingestion of components of, or substances contained in, the device; and</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(h)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>for a therapeutic vaping device or a therapeutic vaping device accessory that is, or contains, a battery—accords with relevant electrical safety standards to protect against overheating, short-circuiting, and the risk of explosion during use and recharging; and</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.56pt; text-indent:0pt; display:inline-block"> </span><span>prevents leaks of the therapeutic vaping substance being vaporised; and</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(j)</span><span style="width:8.56pt; text-indent:0pt; display:inline-block"> </span><span>ensures that all materials used in the inhalation pathway of the device, including any by-products or degradants, are biocompatible and the amount of harmful chemicals (such as heavy metals, volatile organic compounds, and other toxic substances) that the patient receives is less than the tolerable exposure limit below which there would be no appreciable risk to human health</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; 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" style="margin-left:23.25pt; text-indent:-23.25pt"><span>6</span></p></td><td style="width:87.2%; 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="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>the name (including brand name) of a therapeutic vaping device or a therapeutic vaping device accessory must not:</span></p><p style="margin-top:3pt; margin-left:19.4pt; 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>be in any way attractive to children or adolescents; and</span></p><p style="margin-left:19.4pt; text-indent:-18pt"><span style="font-size:10pt">(b)</span><span style="width:6.34pt; text-indent:0pt; font-size:10pt; display:inline-block"> </span><span style="font-size:10pt">whether expressly or by implication—</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>suggest that the device is a food, beverage or cosmetic product; or</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>suggest that the device has health benefits other than its intended purpose, including healing, vitalising, natural, organic or rejuvenating properties; or</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>suggest that the device is safe, without harm or without side effects; or</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>promote the use or supply of the device; or</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(v)</span><span style="width:6.19pt; text-indent:0pt; display:inline-block"> </span><span>exaggerate, or be likely to exaggerate, the efficacy or performance of the device; or</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(vi)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>encourage, or be likely to encourage, inappropriate or excessive use of the device</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; 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" style="margin-left:23.25pt; text-indent:-23.25pt"><span>7</span></p></td><td style="width:87.2%; 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="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>all of the following matters:</span></p><p style="margin-top:3pt; margin-left:19.4pt; 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>a therapeutic vaping device or a therapeutic vaping device accessory must be supplied with instructions for use of the device that are:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>in English (noting the instructions may also be provided in any other language); and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>clearly legible; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>supplied in paper or electronic format that is readily accessible to patients;</span></p><p class="Tabletext" style="margin-left:19.4pt; text-indent:-18pt"><span>(b)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>where the instructions for use are supplied in electronic format—a paper copy must be provided, without charge, to a patient upon request;</span></p><p class="Tabletext" style="margin-left:19.4pt; text-indent:-18pt"><span>(c)</span><span style="width:6.9pt; text-indent:0pt; display:inline-block"> </span><span>the instructions for use must contain the following information, in a text size of at least 3</span><span> </span><span>mm:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>the manufacturer’s name, or trading name, and address;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>the intended purpose of the device, the intended user of the device, and the kind of patient on whom the device is intended to be used;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>the device name, brand name and model;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>the batch code, lot number or serial number that identifies the kind of medical device;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(v)</span><span style="width:6.19pt; text-indent:0pt; display:inline-block"> </span><span>any particular handling or storage requirements applying to the device, including recommended storage conditions;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(vi)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>any warnings, restrictions or precautions that may apply in relation to the use of the device, including a statement that informs the patient or user to seek advice from a healthcare professional if the device is not functioning correctly;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(vii)</span><span style="width:0.63pt; text-indent:0pt; display:inline-block"> </span><span>if applicable, information about the risks associated with button or coin batteries;</span></p><p class="ListParagraph" style="margin-left:33.75pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(viii)</span><span style="width:0.1pt; text-indent:0pt; display:inline-block"> </span><span>any actions that need to be performed prior to using the device, including any preparatory actions for first-time use;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ix)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>information about how to use the device, including instructions for assembly;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(x)</span><span style="width:6.19pt; text-indent:0pt; display:inline-block"> </span><span>any cleaning requirements for the device;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(xi)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>information about the replacement of the consumable components of the device during its expected lifetime, including the size and type of battery;</span></p><p class="ListParagraph" style="margin-left:40.85pt; text-indent:-21.25pt; line-height:115%; font-size:10pt"><span>(xii)</span><span style="width:4.03pt; text-indent:0pt; display:inline-block"> </span><span>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;</span></p><p class="ListParagraph" style="margin-left:40.85pt; text-indent:-21.25pt; line-height:115%; font-size:10pt"><span>(xiii)</span><span style="width:1.25pt; text-indent:0pt; display:inline-block"> </span><span>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</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; 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" style="margin-left:23.25pt; text-indent:-23.25pt"><a id="_Hlk175314291"><span>8</span></a></p></td><td style="width:87.2%; 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="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>all of the following matters:</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>a therapeutic vaping device must be labelled with information that is:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>in English; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>clearly legible; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%"><span style="line-height:115%; font-size:10pt">(iii)</span><span style="width:2.85pt; text-indent:0pt; line-height:115%; font-size:10pt; display:inline-block"> </span><span style="line-height:115%; font-size:10pt">printed in a manner that is durable;</span><span> </span><span style="line-height:115%; font-size:10pt">and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>in a text colour that is matte grey or matte black, unless required by an applicable standard to be another colour; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(v)</span><span style="width:6.19pt; text-indent:0pt; display:inline-block"> </span><span>in a text colour that contrasts with the colour of the therapeutic vaping device;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>the label on the therapeutic vaping device must be matte white or matte grey, unless required by an applicable standard to be another colour;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>the label must contain the following information on the device itself:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>the sponsor’s name;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>the device name, brand name and model;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>the batch code, lot number or serial number that identifies the kind of medical device;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>the warning statement “Risk of fire or explosion. Replace only with the same size and type of battery”;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>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:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>the address of the sponsor;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>the name and address of the manufacturer;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>the information required by paragraphs (c) and (d) must be displayed in a text size of at least 3</span><span> </span><span>mm</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; 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" style="margin-left:23.25pt; text-indent:-23.25pt"><span>9</span></p></td><td style="width:87.2%; 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="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>all of the following matters:</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>a therapeutic vaping device accessory must be labelled with information that is:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>in English; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>clearly legible; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>printed in a manner that is durable; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>in a text colour that is matte grey or matte black, unless required by an applicable standard to be another colour; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(v)</span><span style="width:6.19pt; text-indent:0pt; display:inline-block"> </span><span>in a text colour that contrasts with the colour of the therapeutic vaping device;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>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;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>the label must contain the following information on the vaping device accessory itself:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>the device name and model;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>the batch code, lot number or serial number that identifies the kind of medical device;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>if the therapeutic vaping device accessory contains a battery (of any kind)—the warning statement “Risk of fire or explosion. Replace only with the same size and type of battery”;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>the label must contain the following information on the vaping device accessory itself, or on the packaging or instructions for use of the vaping device accessory if it is impracticable or inappropriate to be on the vaping device accessory itself:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>the brand name;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>the sponsor’s name;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>the address of the sponsor;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>the name and address of the manufacturer;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>the information required by paragraphs (c) and (d) must be displayed in a text size of at least 1</span><span> </span><span>mm</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; 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" style="margin-left:23.25pt; text-indent:-23.25pt"><a id="_Hlk175318673"><span>10</span></a></p></td><td style="width:87.2%; 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="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>all of the following matters:</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>a therapeutic vaping device must be predominantly either matte white or matte grey, and feature no more than 3 other matte colours or shades, including the colour or shade of any text;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>a therapeutic vaping device accessory must be predominantly either matte white, matte grey or matte black, and feature no more than 3 other matte colours or shades, including the colour or shade of any text;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>where the therapeutic vaping device or therapeutic vaping device accessory features a colour or shade other than matte white or matte grey, that colour must not be visible when the device is fully assembled for use;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>a therapeutic vaping device or a therapeutic vaping device accessory may have a clear panel, which must be the smallest size that enables visibility of the amount of therapeutic vaping substance in the device;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>any information on a therapeutic vaping device or therapeutic vaping device accessory must be:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>in English; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>clearly legible; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>printed in a manner that is durable; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>in a text colour that is matte grey or matte black, unless required by an applicable standard to be another colour; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(v)</span><span style="width:6.19pt; text-indent:0pt; display:inline-block"> </span><span>in a text colour that contrasts with the colour of the therapeutic vaping device or therapeutic vaping device accessory;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(f)</span><span style="width:8.01pt; text-indent:0pt; display:inline-block"> </span><span>a therapeutic vaping device or a therapeutic vaping device accessory must not display:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>any words, symbols, trade marks, images, figures, logos or emblems, that are in contravention of another provision of this standard; or</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>any promotional statement, pictorial representation or design;</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(g)</span><span style="width:6.34pt; text-indent:0pt; display:inline-block"> </span><span>a therapeutic vaping device or a therapeutic vaping device accessory must not include any features designed to change the appearance of the device, including the following:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>heat activated inks;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>inks or embellishments designed to appear gradually over time;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>inks that appear fluorescent in certain light;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>panels designed to be scratched or rubbed to reveal an image or text</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; 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" style="margin-left:23.25pt; text-indent:-23.25pt"><a id="_Hlk175553060"><span>11</span></a></p></td><td style="width:87.2%; 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="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><a id="_Hlk161745218"><span>all of the following matters:</span></a></p><p class="ListParagraph" style="margin-left:19.4pt; 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>a therapeutic vaping device or a therapeutic vaping device accessory must be supplied in a primary pack, where the label of the primary pack and the primary pack are white;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>any information on the label of the primary pack and the primary pack must be:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>in English; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>clearly legible; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>printed in a manner that is durable; and</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>in a text colour that is matte grey or matte black, unless required by an applicable standard to be another colour;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>the label of the primary pack and the primary pack must not contain the following:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>any feature that suggests, whether expressly or by implication, that the device has health benefits other than its intended purpose, including healing, vitalising, natural, organic, or rejuvenating properties;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>any words, symbols, trade marks, images, figures, logos or emblems that are in contravention of another provision of this standard;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>any promotional statement, pictorial representation or design;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>the label and packaging must not include any features designed to change the appearance of the primary pack, including the following:</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:8.41pt; text-indent:0pt; display:inline-block"> </span><span>heat activated inks;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:5.63pt; text-indent:0pt; display:inline-block"> </span><span>inks or embellishments designed to appear gradually over time;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:2.85pt; text-indent:0pt; display:inline-block"> </span><span>inks that appear fluorescent in certain light;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(iv)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>panels designed to be scratched or rubbed to reveal an image or text;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(v)</span><span style="width:6.19pt; text-indent:0pt; display:inline-block"> </span><span>removable tabs;</span></p><p class="ListParagraph" style="margin-left:37.15pt; text-indent:-17.85pt; line-height:115%; font-size:10pt"><span>(vi)</span><span style="width:3.41pt; text-indent:0pt; display:inline-block"> </span><span>fold out panels;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>the label of the primary pack must include the warning statements:</span></p><p class="ListParagraph" style="margin-left:33.65pt; text-indent:-14.15pt; line-height:115%; font-size:10pt"><span>(i)</span><span style="width:4.71pt; text-indent:0pt; display:inline-block"> </span><span>“KEEP OUT OF REACH OF CHILDREN”; and</span></p><p class="ListParagraph" style="margin-left:33.65pt; text-indent:-14.15pt; line-height:115%; font-size:10pt"><span>(ii)</span><span style="width:1.93pt; text-indent:0pt; display:inline-block"> </span><span>“WARNING CONTAINS BUTTON OR COIN BATTERY. HAZARDOUS IF SWALLOWED – SEE INSTRUCTIONS” (if applicable); and</span></p><p class="ListParagraph" style="margin-left:33.65pt; text-indent:-14.15pt; line-height:115%; font-size:10pt"><span>(iii)</span><span style="width:1.5pt; text-indent:0pt; display:inline-block"> </span><a id="_Hlk178153871"><span>“RISK OF FIRE OR EXPLOSION. REPLACE ONLY WITH THE SAME SIZE AND TYPE OF BATTERY”</span></a><span> (if applicable);</span></p><p class="ListParagraph" style="margin-left:19.4pt; text-indent:-18pt; line-height:115%; font-size:10pt"><span>(f)</span><span style="width:8.01pt; text-indent:0pt; display:inline-block"> </span><span>the warning statements required by paragraph (e) must be in bold</span><span>‑</span><span>face, sans serif, capital letters of uniform thickness and size</span></p></td></tr><tr style="height:1pt"><td style="width:12.8%; 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" style="margin-left:23.25pt; text-indent:-23.25pt"><a id="_Hlk167172877"><span>12</span></a></p></td><td style="width:87.2%; 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="ListParagraph" style="margin-top:3pt; margin-left:0pt; line-height:115%; font-size:10pt"><span>a therapeutic vaping device or a therapeutic vaping device accessory must be subject to a toxicological risk assessment of the emissions from the device, for the expected lifetime of the device, including but not limited to an assessment of all of the following, having regard to the generally acknowledged state of the art:</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>the atomiser (or the part of the device that heats and vaporises the therapeutic vaping substance);</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>all materials within the device that the therapeutic vaping substance and its vapour come in contact with;</span></p><p class="ListParagraph" style="margin-left:19.4pt; 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>any leachable substances, contaminants and thermal degradation products from the device</span></p></td></tr></tbody></table>

Source text: opening excerpt

Sourced from the Federal Register of Legislation (legislation.gov.au), CC BY 4.0.

1 Name

This instrument is the Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023.

3 Authority

This instrument is made under subsection 41CB(1) of the Therapeutic Goods Act 1989.

4 Definitions

Note 1: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:

(a) essential principles;
(b) medical device standard;
(c) therapeutic goods.

In this instrument:

accredited certification body means a body that is accredited to undertake certification for compliance with IEC 60086-1, IEC 62133-1 or IEC 62133-2, by an International Electrotechnical Commission accepted national certification body.

Act means the Therapeutic Goods Act 1989.

AS/NZS 3820 means Australian/New Zealand Standard AS/NZS 3820, Essential safety requirements for electronic equipment, published jointly by, or on behalf of, Standards Australia and Standards New Zealand, as in force or existing from time to time.

Note: AS/NZS 3820 is published at www.standards.org.au.

AS/NZS 4417.1 means Australian/New Zealand Standard AS/NZS 4417.1, Marking of electronic products to indicate compliance with regulations, published by, or on behalf of, Standards Australia and Standards New Zealand, as in force or existing from time to time.

Note: AS/NZS 4417.1 is published at www.standards.org.au.

IAF accredited organisation means an organisation that is accredited to undertake certification for compliance with ISO 13485 (or both) by an accreditation body member that is a signatory to the Multilateral Recognition Arrangement of the International Accreditation Forum, Inc., otherwise known as the IAF MLA.

IEC 60086-1 means IEC 60086-1, Primary Batteries – Part 1: General, published by the International Electrotechnical Commission, as in force or existing from time to time.

Note: IEC 60086 is published at .

Below is a practical, source-grounded compliance checklist and roadmap, with pointers to the relevant parts of the instrument. The steps assume you are dealing with a product that falls within the instrument’s application (s 6).

Confirm scope and intended use (s 6). Verify that the device or accessory:
- was excluded under item 16 of the table in Schedule 1 to the Therapeutic Goods (Excluded Goods) Determination 2018 immediately before the 2023/2024 changes; and
- is intended only to administer, or contain, a therapeutic vaping substance whose only indication is smoking cessation or management of nicotine dependence. If either element is not satisfied, this Order may not apply.
Establish the quality management certificate (Schedule 1 item 1). Obtain ISO 13485 certification for manufacture, issued by one of the acceptable bodies listed:
- an IAF accredited organisation; or
- a notified body; or
- an auditing organisation recognised by Health Canada; or
- an Australian conformity assessment body determined under the MD Regulations. Maintain the certificate and ensure it covers the specific manufacturing sites and product families.
Build and maintain an ISO 14971-compliant risk management file (Schedule 1 item 2(b)). The file must document assessment and controls for the enumerated hazards in item 2(a):
- toxicity of emissions (expected lifetime);
- toxicity of materials and residues/contaminants (expected lifetime);
- battery hazards (risk of fire/explosion), electrical hazards;
- usability risks and foreseeable misuse;
- containment and administration of the therapeutic vaping substance; and
- heating risks. Ensure traceability from hazard identification through risk control measures, verification evidence and residual risk statements.
Complete battery and electrical safety certification/testing (Schedule 1 item 3 and 4).
- For primary batteries (non-button): obtain IEC 60086-1 certification from an accredited certification body.
- For secondary lithium batteries (non-button): obtain UN/DOT 38.3 certification or a declaration of conformity supported by independent test reports from ISO 17025 accredited laboratories, and IEC 62133-2 certification by an accredited certification body.
- For nickel system secondary batteries: obtain IEC 62133-1 certification.
- For button batteries: ensure compliance with the specified 2020 Consumer Goods instruments listed in item 3(d).
- For electrical safety and marking: ensure compliance with AS/NZS 3820 and AS/NZS 4417.1 (item 4), and retain evidence.
Design to the device performance and safety prescriptions (Schedule 1 item 5).
- Verify emitted mass or dose in accordance with the manufacturer’s instructions, and document verification.
- Implement a reliable venting mechanism that channels the pressure wave to minimise harm.
- Minimise inadvertent actuation and design to prevent leaks of the therapeutic vaping substance.
- Ensure external parts other than the mouthpiece do not exceed 48°C during use, and the mouthpiece does not exceed 55°C during use; perform thermal testing and document results.
- Incorporate child-resistant features preventing operation by children and accidental ingestion.
- Ensure electrical safety measures protect against overheating, short-circuiting, explosion during use and recharging.
- Ensure durability for regular and foreseeable misuse without unsafe failure.
- Verify biocompatibility of all inhalation-pathway materials and demonstrate harmful chemicals are below tolerable exposure limits.
Prepare the toxicological risk assessment of emissions (Schedule 1 item 12).
- Assess atomiser heating element, materials in contact with therapeutic vaping substance and vapour, leachables, contaminants and thermal degradation products for the expected lifetime of the device.
- Use the generally acknowledged state of the art to justify methodologies, thresholds and conclusions.
Implement labelling, instructions and packaging exactly as required (Schedule 1 items 6-11).
- Names and branding must not be attractive to children or adolescents, or imply food/beverage/cosmetic identity, or health benefits beyond intended purpose (item 6). Review brand names and product descriptors for conformance.
- Prepare instructions for use in English, legible, in paper or accessible electronic format, and provide a free paper copy on request (item 7(a)-(b)). Ensure the information list in item 7(c)(i)-(xiii) is included in at least 3 mm text size where specified.
- Label the device in English, legibly, durably, with specified text colour constraints and matte label colour requirements (item 8). Ensure the device carries sponsor name, device name/brand/model, batch code/lot/serial identifier and the exact battery warning phrase.
- For accessories, follow item 9 label content and make sure accessory label text size is at least 1 mm where required.
- Ensure the device appearance conforms to item 10: predominant matte colour limits, no more than three other matte colours or shades, clear panels only as the minimum necessary, and prohibition of promotional statements or features that change appearance over time.
- Primary pack must be white and conform to detailed labelling prohibitions and required warnings, including “KEEP OUT OF REACH OF CHILDREN” and other specified warnings in bold capital letters (item 11).
Verify typography and colour specifications. Confirm that text colours are matte grey or matte black (unless an applicable standard requires another colour), that label text contrasts with device colour, and that required text sizes are met (items 7(c), 8(e), 9(e)).
Collate and retain documentary evidence for regulatory review. Maintain:
- ISO 13485 certificate and scope documentation;
- Risk management file, hazard analyses, traceability matrices and validation reports;
- Battery certifications, IEC certificates, UN/DOT 38.3 test reports supported by ISO 17025 laboratory documentation where required;
- AS/NZS conformity evidence;
- Toxicological assessment reports;
- Labelling and packaging proofs and production records demonstrating the matte colours and typography used;
- Instructions for use applicable to each product family, with evidence of provision (paper/electronic) and availability on request.
Audit suppliers and certifiers. Because acceptable certifiers are narrowly defined, confirm accreditations of auditing and testing bodies against the definitions in s 4 (IAF accredited organisation, notified body, ISO 17025 accreditation, etc.). Document supplier certificates’ provenance and scope.
Implement transitional inventory controls (s 8). For stock imported or manufactured before 1 March 2025 and supplied before 1 July 2025, document import/manufacture dates and ensure supply deadlines are met if relying on the former order. For new manufacture or import after those dates, ensure full compliance with the current Order.
Prepare for regulator inspection or application processes. Because s 7(2) gives a conformity-status effect to Schedule 1 compliance, ensure that applications to regulators, ARTG listing processes or other administrative steps include the Schedule 1 compliance evidence. Anticipate regulator requests for certificates, test reports and the risk management file.
Review marketing collateral and training. Ensure that promotional materials, training documents, and any product launch content do not conflict with the device name or labelling restrictions in item 6 and the ban on promotional content in items 10 and 11.
Maintain an ongoing monitoring process for standards updates. Many referenced standards are defined "as in force or existing from time to time" (s 4 definitions), which implies that changes in those external standards may alter compliance expectations. Implement a monitoring process to update certificates or testing strategies when standard editions change.

Following this sequence, and keeping documentary support mapped to each Schedule 1 item, will put a sponsor or manufacturer in the posture of being able to claim, under s 7(2), that the device is to be treated as complying with the essential principles in the MD Regulations. Ensure that all certifying bodies and laboratories used are accredited as required by the instrument’s definitions.

Therapeutic Goods (Medical Device Standard—Therapeutic Vaping Devices) Order 2023

Plain English Summary

Deep Dive

What it does

Current sections

Name

1 Name

Authority

3 Authority

Definitions

4 Definitions

Application

6 Application

Medical device standard

7 Medical device standard

Source text: opening excerpt

1 Name

1 Name

3 Authority

3 Authority

4 Definitions

4 Definitions

Main concepts

Who it affects

Key duties and rights

Penalties and enforcement

How it interacts with other laws

Amendment history

Litigation history

Gotchas

How to comply

6 Application

6 Application

7 Medical device standard

7 Medical device standard