Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023

The central concept is the definition of a medical device under the Act and the power to declare that a specified article is not a medical device. The Act defines a medical device broadly as any instrument, apparatus, appliance, software, implant, reagent, material or other article intended for a therapeutic purpose that does not achieve its principal intended action through pharmacological, immunological or metabolic means. This instrument carves out specific articles from that definition, meaning they are not subject to the medical device regulatory framework. Instead, they must be regulated under other parts of the Act if they are therapeutic goods. The instrument uses the term “articles” to cover instruments, apparatus, appliances, software, implants, reagents, materials, or other articles, and specifies them by class in Schedule 1. Many items rely on terms defined elsewhere. For example, “fungicide”, “hospital grade disinfectant”, “household grade disinfectant”, “sporicide”, “sterilant”, “tuberculocide” and “virucide” have the same meaning as in the Therapeutic Goods Regulations 1990 (the Regulations). “Therapeutic vaping device”, “therapeutic vaping device accessory” and “therapeutic vaping pack” have the same meaning as in the MD Regulations. “Therapeutic vaping substance” and “therapeutic vaping substance accessory” are also cross-referenced. This means the scope of the declaration can shift if the underlying definitions in the Regulations or MD Regulations change. Another key concept is the “principal intended action” test used in items 13 to 16. Toothpastes and other dentifrices that achieve their principal intended action through chemical or pharmacological means are not medical devices. Head or body lice treatments, moisturisers and emollients, and weight loss treatments that act by chemical, pharmacological or metabolic means are similarly excluded. This test requires a fact-based assessment of the product’s primary mode of action. If the principal intended action is physical (e.g., mechanical abrasion in a toothpaste) the product may remain a medical device. The instrument does not provide guidance on how to determine the principal intended action, creating interpretation risk. The transitional regime for items 13 to 16 is a further key concept. It preserves the existing medical device status of those articles that were already in the Register as devices, allowing a transition period. During that period the products remain medical devices and must comply with the MD Regulations. After transition they are no longer devices and must comply with the applicable medicine pathway. The concept of “single integral product” appears in items 3 and 12. Item 3 covers articles intended to administer a medicine where the medicine and article form a single integral product intended exclusively for use in that combination and that are not reusable (may be multi-dose). Item 12 covers vaping devices pre-filled with a therapeutic vaping substance that form a single integral product and are not reusable. These items recognise that when a device and medicine are inseparable the whole product is more appropriately regulated as a medicine or as a therapeutic good under other provisions. The instrument also distinguishes between articles that contain human or animal tissues. Items 1 and 2 exclude articles incorporating tissues, cells or substances of human origin (with a saving for stable derivatives of human blood or plasma) and articles incorporating viable animal tissues. These are not medical devices, but may be regulated as biologicals or medicines.

The instrument directly affects sponsors, manufacturers, importers and exporters of the articles listed in Schedule 1. For items 1 to 12 the effect is immediate: those articles are not medical devices from the date of the original declaration. Sponsors who previously held ARTG entries for these products as medical devices must apply to have those entries cancelled or varied, and if the product is a therapeutic good must apply for listing or registration under the appropriate medicine or biological pathway. This includes manufacturers of chemical oxygen generators (item 4), hospital or household grade disinfectants claimed to be sterilants, fungicides, sporicides, tuberculocides or virucides (item 5), in-vivo imaging agents (item 6), riboflavin products for corneal crosslinking (item 7), topical decontamination products for chemical, biological or radiological warfare agents (item 8), unmedicated nappy rash barrier preparations (item 9), and therapeutic vaping devices and accessories in a therapeutic vaping pack (item 10), therapeutic vaping substance accessories (item 11), and pre-filled vaping devices that are single integral products (item 12). Specially affected are the sponsors of items 13 to 16. These are producers of toothpastes and other dentifrices that act by chemical or pharmacological means, head or body lice treatments, moisturisers and emollients that act by chemical, metabolic or pharmacological means, and weight loss treatments that affect caloric absorption by metabolic means. Many of these products were previously included in the Register as medical devices and must now transition to medicine regulation. The Australian Register of Therapeutic Goods (ARTG) will need to reflect these changes. Regulators at the Therapeutic Goods Administration (TGA) must process the reclassification and manage the transitional arrangements. Consumers and healthcare professionals may see changes in product labelling, advertising and regulatory oversight. For example, a toothpaste that was previously regulated as a medical device may now need to comply with the requirements for listed medicines, including different manufacturing standards and advertising restrictions. The instrument also affects distributors and retailers who supply these products; they rely on the sponsor to maintain lawful ARTG entries. If a sponsor fails to transition by 1 January 2031 for items 13 to 16, the product becomes an unapproved therapeutic good and cannot be supplied. The instrument does not directly affect end users, but the regulatory classification change may affect product availability and price if compliance costs increase. The free market impact is mixed: some products (like therapeutic vaping devices) are removed from the costly device conformity assessment regime, potentially lowering supply costs. Others (like dentifrices) are moved into the medicine regime, which may involve higher application fees and evidence requirements, creating a barrier to entry for smaller manufacturers. Competitors who already hold medicine listings gain a relative advantage.

The instrument is declaratory and does not itself impose duties or confer rights. However, it has the legal effect of changing the duties and rights that apply under the Act. For articles that are declared not to be medical devices, the sponsor is no longer required to comply with the medical device provisions of the Act and the MD Regulations. This includes the duty to include the device in the ARTG as a medical device, to apply conformity assessment procedures, to maintain a manufacturer’s quality management system meeting the standards for devices, to report adverse events specific to devices, and to comply with device-specific labelling and advertising rules. Instead, if the article is a therapeutic good (i.e., it makes a therapeutic claim), the sponsor must comply with the duties that apply to that category of therapeutic good. Typically this means the article must be included in the ARTG as a listed good or a registered good under Part 3-2 of the Act. Listed goods require compliance with the Therapeutic Goods (Listing) Notice and must meet the requirements for low-risk medicines. Registered goods require evaluation by the TGA and a higher level of evidence. If the article is not a therapeutic good (e.g., a plain moisturiser that makes no therapeutic claims), it falls outside the Act entirely and no TGA duties apply. For articles covered by the transitional provisions (items 13 to 16 that were already medical devices in the Register), the sponsor has a right to continue supplying the product as a medical device during the transition period, but also has a right to apply for registration or listing from 1 January 2026. Section 6(3) provides that from that date the articles may be dealt with as if the declaration applies for the purposes of an application for registration or listing and any applicable provisions in Part 3-2. This allows sponsors to begin the process of converting their product to a medicine while still relying on the medical device entry for supply. However, the product remains a medical device until the earlier of the date it becomes registered/listed or 1 January 2031. This means that during the transition the sponsor must comply with both sets of obligations. The instrument confers no right to compensation for the costs of reclassification. Sponsors of items 1 to 12 that were never medical devices or that were not included in the Register as medical devices before the amendment have no transitional rights. They must comply immediately. For vaping products (items 10 to 12), the definitions of “therapeutic vaping device” and related terms are cross-referenced to the MD Regulations and the Regulations. This means that if those definitions change, the scope of the declaration changes automatically. Sponsors have a right to rely on the current definitions, but also an exposure to future regulatory changes without further amendment to this instrument. The instrument does not create private rights of action. A competitor who believes a product is wrongly classified would need to complain to the TGA or seek judicial review of a TGA decision.

The instrument contains no penalties of its own. Enforcement is through the Therapeutic Goods Act 1989. Supplying an article that is a therapeutic good without it being included in the ARTG is a criminal offence under section 20 of the Act, with maximum penalties of up to 5 years imprisonment and fines of up to $1.1 million for individuals and $5.5 million for bodies corporate (current penalty units). Strict liability offences also apply. If an article is declared not to be a medical device but the sponsor continues to hold it out as a medical device (e.g., by maintaining a medical device ARTG entry after the transition period ends), that could breach the Act’s provisions on false or misleading representations. Similarly, if a sponsor fails to transition a product subject to items 13 to 16 by 1 January 2031, and the product is still a therapeutic good but not registered or listed, supply becomes unlawful. The TGA can issue infringement notices, institute criminal proceedings, or seek civil penalties. The TGA also has powers to suspend or cancel ARTG entries if goods do not comply. For the transitional period, if a sponsor of an item 13-16 product continues to supply it as a medical device without maintaining compliance with the MD Regulations, the TGA may take enforcement action for non-compliance with device requirements. If the sponsor begins supplying it as a medicine prematurely without the appropriate ARTG inclusion, that could also be an offence. The instrument does not provide any safe harbour for sponsors who mistakenly classify their product - the usual rules on reasonable mistake of fact and due diligence apply. Because the classification depends on factual assessments of “principal intended action”, borderline cases may lead to disagreements with the TGA. The TGA may audit products and require sponsors to justify their classification. The transitional provisions were clearly intended to avoid a sudden cliff where many formerly registered devices become non-compliant overnight. However, the 1 January 2031 deadline is absolute; there is no provision for extensions. Sponsors who miss the deadline face enforcement risk. The instrument itself is not subject to enforcement; it is a definitional instrument. The real penalties arise from the underlying Act. The cost of non-compliance includes legal fees, potential supply interruptions, and reputational damage.

This instrument is made under the Therapeutic Goods Act 1989 and interacts with several other pieces of legislation. First, it interacts with the Therapeutic Goods (Medical Devices) Regulations 2002 (MD Regulations) because the declaration removes articles from the definition of medical device, meaning they are not subject to those Regulations. Second, it interacts with the Therapeutic Goods Regulations 1990, which contain the definitions of many terms used in the Schedule (fungicide, disinfectant grades, sporicide, etc.). Any change to those definitions automatically alters the scope of the declaration. Third, it interacts with the Australian Register of Therapeutic Goods (ARTG). Articles that were previously included as medical devices (particularly items 13 to 16) must transition to being included as registered goods or listed goods. This may require interaction with the Therapeutic Goods (Listing) Notice 2022 or the requirements for registered medicines under the Act. The instrument also interacts with the Poisons Standard (Standard for the Uniform Scheduling of Medicines and Poisons) for vaping products and other therapeutic goods that contain scheduled substances. For example, therapeutic vaping substances may contain nicotine or other scheduled poisons, and their supply is further regulated by state and territory laws. The declaration that a vaping device is not a medical device does not affect those state controls. Items 1 and 2 (human and animal tissues) interact with the Therapeutic Goods (Biologicals) framework. Biologicals are regulated under Part 3-2A of the Act. Articles incorporating viable animal tissues or human tissues (other than certain blood derivatives) are excluded from being medical devices, but they may be biologicals. Items 3 and 12 (single integral products) interact with medicine regulations: the combined product is not a device, so the medicine component is regulated under the usual medicine provisions, and the device component (e.g., the syringe or the inhaler) is not separately regulated as a device. This avoids dual regulation. Item 4 (chemical oxygen generators) may interact with workplace health and safety laws, the Dangerous Goods Code, and civil aviation safety regulations. Item 5 (disinfectants) may also be regulated under the Agricultural and Veterinary Chemicals Code Act 1994 if used in agriculture, or under state health regulations. Item 7 (riboflavin products) are used with UV-A light devices; the light device remains a medical device. The instrument does not affect the regulation of that device. Item 8 (CBRN decontamination products) may interact with defence legislation or emergency management laws. Item 9 (nappy rash barrier preparations) may interact with cosmetics regulation if they make no therapeutic claims; if they do make therapeutic claims they are regulated as therapeutic goods. The instrument itself does not delegate any further law-making power; it is a one-time declaration. The transitional provisions in section 6 interact with Part 3-2 of the Act for applications. Section 6(3) deems that from 1 January 2026 the declaration applies for the limited purpose of making an application. This is a unique deeming mechanism that modifies the effect of the Act for those applications. The instrument must be read together with the Act; the declaration does not override any other provision of the Act except by affecting the definition of medical device. No other Commonwealth laws are expressly referenced, so state laws on health and safety continue to apply.

The Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023 was originally made in 2023. The source text shows that it has been amended by the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025. The amendment inserted items 13 to 16 into the table in Schedule 1 and added section 6, which contains application, saving and transitional provisions. The original 2023 declaration therefore contained items 1 to 12. The amendment also added the note to item 7 (riboflavin products) and the definitions for “therapeutic vaping device”, “therapeutic vaping device accessory”, “therapeutic vaping pack”, “therapeutic vaping substance”, and “therapeutic vaping substance accessory”. These definitions may have been present in the original 2023 declaration as well; the source does not indicate they were added by the 2025 amendment. The amendment specifically refers to “therapeutic vaping device” and related terms as having the same meaning as in the MD Regulations. The source also lists definitions for “therapeutic vaping substance accessory” and “vaping device”. It is not clear from the source whether a “No. 1” amendment exists; no such instrument is mentioned. The section 6 transitional provisions apply only to items 13 to 16 and refer to “immediately before the commencement of the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025”. This confirms that the amendment is the only one to have added those items. The instrument as presented includes all 16 items and the transitional provisions, meaning it is a consolidated version. The original declaration would have been a separate instrument. No other amendments are indicated by the source. The amendment history is relevant because it shows that the TGA added consumer products (dentifrices, lice treatments, moisturisers, weight loss treatments) to the exclusion list in 2025. This likely reflects a policy shift or a resolution of borderline classification issues. The amendment gave a generous transition period of about 6 years. The source does not include any explanatory statement or regulation impact statement. The amendment was likely made to respond to industry requests for clarity or to align with international practice. The instrument remains in force until revoked or amended.

The source does not refer to any litigation concerning this instrument. No cases are cited in the text. The Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023 is a relatively recent delegated instrument, and as of the source date there may be no reported judicial decisions that interpret it. The underlying power in subsection 41BD(3) of the Act has been in other contexts, but not specifically for this declaration. The classification of particular products under this instrument could theoretically be challenged. For example, a sponsor who disagrees that their toothpaste’s principal intended action is chemical or pharmacological might seek judicial review of the TGA’s decision to enforce the declaration. Or a manufacturer of a disinfectant could argue that their product does not meet the definition of hospital grade disinfectant under the Regulations and should remain a medical device. The transitional provisions in section 6 could also give rise to disputes if a sponsor fails to meet the 1 January 2031 deadline and the TGA takes enforcement action. However, no such litigation is recorded in the source. The instrument itself is not self-executing; litigation would likely be about the TGA’s interpretation or enforcement decisions based on the declaration. The lack of litigation history does not mean the instrument is uncontroversial. It may simply reflect that the TGA has not yet taken enforcement action that leads to a challenge, or that sponsors are complying or settling matters administratively. Sponsors should be aware that the principal intended action test in items 13 to 16 is particularly open to interpretation and could be the subject of future litigation. The instrument’s reliance on definitions in other regulations also creates a risk that a challenge to the validity of those definitions could indirectly affect this declaration. As of the source date, there is no case law to guide practitioners on how the TGA or courts will apply the “principal intended action” test to a multi-modal product like a toothpaste that both scrubs and chemically whitens. The absence of litigation history is a prudent warning: regulatory risk remains until the boundaries are tested.

Several traps arise from this instrument. First, the transitional provisions in section 6 apply only to articles that were “included in the Register as a kind of medical device immediately before the commencement of the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025.” This is a narrow grandfather: if a product was not yet included as a medical device (e.g., a new product seeking inclusion), it receives no transition and is immediately not a medical device. That sponsor must instead apply for listing or registration as a medicine from day one. Second, for items 13 to 16, the transition period ends at the earlier of inclusion as registered/listed goods or 1 January 2031. If a sponsor obtains registration as a listed good before 1 January 2031, the declaration applies immediately, and the product ceases to be a medical device. That means the sponsor must ensure the product no longer relies on its medical device entry. If they continue to hold both a device entry and a medicine entry for the same product, the TGA may treat the device entry as incorrectly held and potentially cancel it. Third, from 1 January 2026 a sponsor may apply for registration or listing under section 6(3), but the product remains a medical device until the application is approved and the goods become registered/listed. During that period the product must continue to comply with the MD Regulations. This bifurcated regime imposes dual compliance costs. Fourth, the definitions of “therapeutic vaping device”, “therapeutic vaping device accessory” and related terms are cross-referenced to the MD Regulations and the Regulations. If those underlying definitions are amended, the scope of items 10 to 12 changes automatically without further amendment of this instrument. Sponsors must monitor those regulations. Fifth, the “principal intended action” test in items 13 to 16 is not elaborated. A toothpaste that whitens teeth both by physical abrasion and by chemical bleaching could be argued either way. The sponsor bears the risk of misclassification. If the TGA later decides the principal intended action is chemical, the product must be reclassified as a medicine, potentially with retrospective liability. Sixth, item 5 excludes only hospital grade or household grade disinfectants that claim to be sterilants, fungicides, sporicides, tuberculocides or virucides. If a disinfectant makes a claim as a medical device (e.g., disinfecting medical instruments) but is not one of those specific types, it may still be a medical device. The instrument does not exclude all disinfectants. Seventh, item 3 excludes “articles that are intended to administer a medicine in such a way that the medicine and the article form a single integral product which is intended exclusively for use in the given combination and that are not reusable”. This covers pre-filled syringes. However, if the article is reusable (e.g., a multi-use pen injector where the cartridge is replaceable but the device part is reused), it does not fall under item 3 and may remain a medical device. The line between single-use and reusable can be fine. Eighth, item 12 similarly excludes pre-filled vaping devices that are single integral product and not reusable. A reusable vaping device with replaceable pods would not qualify and may still be a medical device (if it meets the definition). Ninth, item 1 provides an exception for medical devices incorporating stable derivatives of human blood or human plasma. That saving preserves the device status of certain blood-derived devices, but only if they act ancillary to the device. If the derivative acts systemically, the product may be a biological. Tenth, the instrument contains no sunset or review clause. It continues indefinitely until revoked. There is no automatic reassessment of whether the exclusions remain appropriate. Sponsors must also be aware that the Act itself may be amended, which could affect the scope of this instrument. For example, if the definition of “medical device” in the Act is changed, this instrument’s exclusions may need to be revisited.

Compliance requires first determining whether a product falls within any item in Schedule 1. If it does, the product is not a medical device. The sponsor must then determine whether the product is a therapeutic good under the Act. If it makes a therapeutic claim (e.g., “prevents tooth decay”, “treats head lice”, “relieves dry skin”, “aids weight loss”), it will be a therapeutic good and must be included in the ARTG in the appropriate category. For items 13 to 16, if the product was previously included as a medical device, the sponsor has until 1 January 2031 to obtain inclusion as a listed or registered good. The sponsor should begin the process as early as possible. From 1 January 2026, the sponsor may apply as if the declaration applied, using section 6(3) to support the application. The product remains a medical device until the new entry is granted, so all medical device obligations - including conformity assessment, quality management system, adverse event reporting, and ARTG maintenance - continue in full effect. The sponsor must not cancel the existing device entry until the new medicine entry is finalised. After the new entry is granted, the declaration applies and the product ceases to be a medical device; the device entry should then be cancelled. If the product is not a therapeutic good (e.g., a plain moisturiser with no therapeutic claims), no ARTG entry is needed. However, claims must be carefully reviewed; any implicit therapeutic claim (e.g., “soothes irritation”) may trigger therapeutic good classification. For items 1 to 12, there is no transition. If the product was previously included as a medical device, the sponsor should immediately apply to have the device entry cancelled and, if the product is a therapeutic good, apply for appropriate ARTG inclusion. If it is not a therapeutic good, the product falls outside the Act and no ARTG entry is needed. For vaping products (items 10 to 12), sponsors must ensure compliance with the Poisons Standard, state and territory laws on vaping, and the definitions in the MD Regulations and Regulations. The therapeutic vaping substance must be in a therapeutic vaping pack; the device and accessory definitions must be met. Sponsors should keep records of the basis for classification, especially for items using the “principal intended action” test or the “single integral product” test. This includes scientific literature, regulatory opinions, and correspondence with the TGA. For products that are borderline, seeking a TGA classification advice or using the TGA’s medical device/medicine classification tool is prudent. Sponsors must also monitor any amendments to this instrument or to the definitions it incorporates. The instrument does not require reporting of compliance, but the TGA may audit. The cost of compliance includes application fees for new ARTG entries (listed goods application fees are lower than registered goods but still significant), potential data generation for efficacy, and conformance with manufacturing standards. For small manufacturers, the cost of moving from device to medicine regulation could be a barrier to continued supply. The free market impact is that those who cannot bear the cost may exit, reducing competition. Sponsors should factor these costs into their business planning. The transitional provisions were intended to mitigate disruption, but they still require active management.