1.  The whole of this instrument

1 October 2024.

1 October 2024

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all of the following matters:

(a) ISO 13485 certification for the manufacture of the therapeutic vaping device or the therapeutic vaping device accessory, issued by one of the following:

(i) an IAF accredited organisation;

(ii) a notified body;

(iii) an auditing organisation recognised by Health Canada;

(iv) an Australian conformity assessment body determined under the MD Regulations;

(b) compliance to ISO 13485 for the manufacture of the therapeutic vaping device or the therapeutic vaping device accessory

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all of the following matters:

(a) 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:

(i) 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

(ii) 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

(iii) hazards or risks relating to batteries (if applicable), including risk of fire or explosion; and

(iv) electrical hazards or risks; and

(v) hazards or risks relating to the usability of the therapeutic vaping device or the therapeutic vaping device accessory; and

(vi) hazards or risks relating to the reasonably foreseeable misuse of the therapeutic vaping device or the therapeutic vaping device accessory; and

(vii) 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

(viii) hazards or risks relating to heating of the therapeutic vaping device or therapeutic vaping device accessory;

(b) 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 (a)

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all of the following matters, as applicable to the therapeutic vaping device or the therapeutic vaping device accessory:

(a) for a primary battery (other than a button battery)—IEC 60086-1 certification (as applicable) issued by an accredited certification body;

(b) for a secondary battery (other than a button battery) that is a lithium battery—both of the following:

(i) 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;

(ii) IEC 62133-2 certification issued by an accredited certification body;

(c) 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;

(d) for a button battery—compliance with all of the following:

(i) the Consumer Goods (Button/Coin Batteries) Information Standard 2020;

(ii) the Consumer Goods (Button/Coin Batteries) Safety Standard 2020;

(iii) the Consumer Goods (Products Containing Button/Coin Batteries) Safety Standard 2020;

(iv) the Consumer Goods (Products Containing Button/Coin Batteries) Information Standard 2020

Note: These legislative instruments are published on the Federal Register of Legislation at www.legislation.gov.au

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all of the following matters, as applicable to the therapeutic vaping device or the therapeutic vaping device accessory:

(a) AS/NZS 3820 compliance with essential safety requirements for low voltage electrical equipment;

(b) AS/NZS 4417.1 compliance with marking of electrical products to indicate compliance with regulations

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a therapeutic vaping device, and a therapeutic vaping device accessory as applicable, must be designed and constructed in a way that:

(a) 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

(b) incorporates a reliable venting mechanism that channels the pressure wave in the direction where the harm is minimised; and

(c) minimises the risk of inadvertent actuation; and

(d) 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

(e) ensures that the external surface of the mouthpiece does not exceed 55°C during use; and

(f) ensures that the device will withstand regular use, and foreseeable misuse or abuse, without breaking, leaking or failing in an unsafe manner; and

(g) incorporates child-resistant features to prevent:

(i) the operation of the device by children; and

(ii) the accidental ingestion of components of, or substances contained in, the device; and

(h) 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

(i) prevents leaks of the therapeutic vaping substance being vaporised; and

(j) 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

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the name (including brand name) of a therapeutic vaping device or a therapeutic vaping device accessory must not:

(a) be in any way attractive to children or adolescents; and

(b) whether expressly or by implication—

(i) suggest that the device is a food, beverage or cosmetic product; or

(ii) suggest that the device has health benefits other than its intended purpose, including healing, vitalising, natural, organic or rejuvenating properties; or

(iii) suggest that the device is safe, without harm or without side effects; or

(iv) promote the use or supply of the device; or

(v) exaggerate, or be likely to exaggerate, the efficacy or performance of the device; or

(vi) encourage, or be likely to encourage, inappropriate or excessive use of the device

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all of the following matters:

(a) a therapeutic vaping device or a therapeutic vaping device accessory must be supplied with instructions for use of the device that are:

(i) in English (noting the instructions may also be provided in any other language); and

(ii) clearly legible; and

(iii) supplied in paper or electronic format that is readily accessible to patients;

(b) where the instructions for use are supplied in electronic format—a paper copy must be provided, without charge, to a patient upon request;

(c) the instructions for use must contain the following information, in a text size of at least 3 mm:

(i) the manufacturer’s name, or trading name, and address;

(ii) 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;

(iii) the device name, brand name and model;

(iv) the batch code, lot number or serial number that identifies the kind of medical device;

(v) any particular handling or storage requirements applying to the device, including recommended storage conditions;

(vi) 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;

(vii) if applicable, information about the risks associated with button or coin batteries;

(viii) any actions that need to be performed prior to using the device, including any preparatory actions for first-time use;

(ix) information about how to use the device, including instructions for assembly;

(x) any cleaning requirements for the device;

(xi) information about the replacement of the consumable components of the device during its expected lifetime, including the size and type of battery;

(xii) either the expiry date for the device or the expected lifetime of the device, indicated as duration of use after the first use or the number of actuations before being discarded;

(xiii) any precautions a patient or user should take if there are risks associated with the disposal of the device, including instructions on how to dispose of the device or its parts, or how to recycle used batteries

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all of the following matters:

(a) a therapeutic vaping device must be labelled with information that is:

(i) in English; and

(ii) clearly legible; and

(iii) printed in a manner that is durable; and

(iv) in a text colour that is matte grey or matte black, unless required by an applicable standard to be another colour; and

(v) in a text colour that contrasts with the colour of the therapeutic vaping device;

(b) the label on the therapeutic vaping device must be matte white or matte grey, unless required by an applicable standard to be another colour;

(c) the label must contain the following information on the device itself:

(i) the sponsor’s name;

(ii) the device name, brand name and model;

(iii) the batch code, lot number or serial number that identifies the kind of medical device;

(iv) the warning statement “Risk of fire or explosion. Replace only with the same size and type of battery”;

(d) the label must contain the following information on the device itself, or on the packaging of the device if it is impracticable or inappropriate to be on the device itself:

(i) the address of the sponsor;

(ii) the name and address of the manufacturer;

(e) the information required by paragraphs (c) and (d) must be displayed in a text size of at least 3 mm

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all of the following matters:

(a) a therapeutic vaping device accessory must be labelled with information that is:

(i) in English; and

(ii) clearly legible; and

(iii) printed in a manner that is durable; and

(iv) in a text colour that is matte grey or matte black, unless required by an applicable standard to be another colour; and

(v) in a text colour that contrasts with the colour of the therapeutic vaping device;

(b) the label on the therapeutic vaping device accessory must be matte white, matte grey or matte black, unless required by an applicable standard to be another colour;

(c) the label must contain the following information on the vaping device accessory itself:

(i) the device name and model;

(ii) the batch code, lot number or serial number that identifies the kind of medical device;

(iii) 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”;

(d) 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:

(i) the brand name;

(ii) the sponsor’s name;

(iii) the address of the sponsor;

(iv) the name and address of the manufacturer;

(e) the information required by paragraphs (c) and (d) must be displayed in a text size of at least 1 mm

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all of the following matters:

(a) 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;

(b) 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;

(c) 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;

(d) 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;

(e) any information on a therapeutic vaping device or therapeutic vaping device accessory must be:

(i) in English; and

(ii) clearly legible; and

(iii) printed in a manner that is durable; and

(iv) in a text colour that is matte grey or matte black, unless required by an applicable standard to be another colour; and

(v) in a text colour that contrasts with the colour of the therapeutic vaping device or therapeutic vaping device accessory;

(f) a therapeutic vaping device or a therapeutic vaping device accessory must not display:

(i) any words, symbols, trade marks, images, figures, logos or emblems, that are in contravention of another provision of this standard; or

(ii) any promotional statement, pictorial representation or design;

(g) 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:

(i) heat activated inks;

(ii) inks or embellishments designed to appear gradually over time;

(iii) inks that appear fluorescent in certain light;

(iv) panels designed to be scratched or rubbed to reveal an image or text

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all of the following matters:

(a) 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;

(b) any information on the label of the primary pack and the primary pack must be:

(i) in English; and

(ii) clearly legible; and

(iii) printed in a manner that is durable; and

(iv) in a text colour that is matte grey or matte black, unless required by an applicable standard to be another colour;

(c) the label of the primary pack and the primary pack must not contain the following:

(i) 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;

(ii) any words, symbols, trade marks, images, figures, logos or emblems that are in contravention of another provision of this standard;

(iii) any promotional statement, pictorial representation or design;

(d) the label and packaging must not include any features designed to change the appearance of the primary pack, including the following:

(i) heat activated inks;

(ii) inks or embellishments designed to appear gradually over time;

(iii) inks that appear fluorescent in certain light;

(iv) panels designed to be scratched or rubbed to reveal an image or text;

(v) removable tabs;

(vi) fold out panels;

(e) the label of the primary pack must include the warning statements:

(i) “KEEP OUT OF REACH OF CHILDREN”; and

(ii) “WARNING CONTAINS BUTTON OR COIN BATTERY. HAZARDOUS IF SWALLOWED – SEE INSTRUCTIONS” (if applicable); and

(iii) “RISK OF FIRE OR EXPLOSION. REPLACE ONLY WITH THE SAME SIZE AND TYPE OF BATTERY” (if applicable);

(f) the warning statements required by paragraph (e) must be in bold‑face, sans serif, capital letters of uniform thickness and size

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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:

(a) the atomiser (or the part of the device that heats and vaporises the therapeutic vaping substance);

(b) all materials within the device that the therapeutic vaping substance and its vapour come in contact with;

(c) any leachable substances, contaminants and thermal degradation products from the device