{"id":"F2023L01088","name":"Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023","slug":"therapeutic-goods-articles-that-are-not-medical-devices-declaration-2023","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":104737,"registerId":"commonwealth-F2023L01088-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\nThis instrument is the Therapeutic Goods (Articles that are Not Medical Devices) Declaration 2023.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\nThis instrument is made under subsection 41BD(3) of the Therapeutic Goods Act 1989.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\nNote: A number of expressions used in this instrument are defined in subsection 3(1) of the Act including:\n\n (a) included in the Register;\n (b) listed goods;\n (c) medical device;\n (d) medicine;\n (e) Register;\n (f) registered goods;\n (g) therapeutic goods.\n\nIn this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nfungicide has the same meaning as in the Regulations.\n\nhospital grade disinfectant has the same meaning as in the Regulations.\n\nhousehold grade disinfectant has the same meaning as in the Regulations.\n\n> MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002\n\nRegulations means the Therapeutic Goods Regulations 1990.\n\nsporicide has the same meaning as in the Regulations.\n\nsterilant has the same meaning as in the Regulations.\n\n> therapeutic vaping device has the same meaning as in the MD Regulations.\n\n> therapeutic vaping device accessory has the same meaning as in the MD Regulations.\n\n> therapeutic vaping pack has the same meaning as in the Regulations.\n\n> therapeutic vaping substance has the same meaning as in the Regulations.\n\ntherapeutic vaping substance accessory has the same meaning as in the Regulations.\n\ntuberculocide has the same meaning as in the Regulations.\n\nvaping device has the meaning given by subsection 41P(1) of the Act.\n\nvirucide has the same meaning as in the Regulations.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Articles that are not medical devices","content":"#### 5 Articles that are not medical devices\n\nFor the purposes of the Act, the instruments, apparatus, appliances, software, implants, reagents, materials or other articles, or classes of instruments, apparatus, appliances, software, implants, reagents, materials or other articles, specified in Schedule 1 are not medical devices.","sortOrder":3},{"sectionNumber":"6","sectionType":"section","heading":"Application, saving and transitional provisions","content":"#### 6 Application, saving and transitional provisions\n\n (1) This section applies to articles in items 13 to 16 of the table in Schedule 1 that, immediately before the commencement of the Therapeutic Goods (Articles that are Not Medical Devices) Amendment Declaration (No. 2) 2025, were included in the Register as a kind of medical device.\n (2) Items 13 to 16 of the table in Schedule 1 do not apply to the medical devices mentioned in subsection (1) until the earlier of:\n (a) the date on which the goods become registered goods or listed goods; and\n (b) 1 January 2031.\n (3) Despite subsection (2), the articles mentioned in subsection (1) may be dealt with as if items 13 to 16 of the table in Schedule 1 apply from 1 January 2026, including for the purposes of the following:\n (a) an application for the registration or listing of the therapeutic goods;\n (b) any applicable provisions in Part 3-2 of the Act in relation to applications for the registration or listing of therapeutic goods.\n\n \n\nSchedule 1—Articles that are not medical devices\n\n> Note: See section 5.\n\n```html\n

Articles that are not medical devices

Column 1

Column 2

Item

Articles or classes of articles

1

articles incorporating tissues, cells or substances of human origin, other than medical devices incorporating stable derivatives of either human blood or human plasma, that act on, or are likely to act on, the human body in a way that is ancillary to the device

2

articles incorporating viable tissues, cells or substances of animal origin

3

articles that are intended to administer a medicine in such a way that the medicine and the article form a single integral product which is intended exclusively for use in the given combination and that are not reusable (may be multi‑dose)

4

chemical oxygen generators

5

hospital grade disinfectants or household grade disinfectants that are claimed to be sterilants, fungicides, sporicides, tuberculocides or virucides

6

in-vivo imaging agents injected, ingested, or otherwise instilled into the body

7

riboflavin products instilled into the eye that are used in the treatment of disorders of the eye which cause structural changes within the cornea

Note: These riboflavin products are used with UV-A light illumination in order to achieve an alteration of the normal chemical process of crosslinking of collagen, with the purpose of making the cornea stronger and more stable.

8

topical applications intended to remove or neutralise chemical, biological or radiological agents used in chemical, biological or radiological warfare

9

unmedicated preparations for topical use for protecting against, or providing relief from, nappy rash symptoms by acting only as a barrier for the skin (whether or not the preparations also have a moisturising action)

10

therapeutic vaping devices or therapeutic vaping device accessories in a therapeutic vaping pack

11

therapeutic vaping substance accessories

12

vaping devices that are pre-filled with a therapeutic vaping substance that form a single integral product which is intended exclusively for use in the given combination and that are not reusable (may be multi-dose)

13

toothpastes and other dentifrices that achieve their principal intended action through having an effect by chemical or pharmacological means

14

head or body lice treatments that achieve their principal intended action through having an effect by chemical or pharmacological means

15

moisturisers and emollients that achieve their principal intended action through having an effect by chemical, metabolic or pharmacological means

16

weight loss treatments that are ingested into the body and that affect absorption of calories in the gastrointestinal system by metabolic means

\n```","sortOrder":4}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":true,"description":"The original 2023 instrument was a straightforward 'negative list' excluding specific borderline products from medical device regulation. The 2025 amendments (evident in section 6 and items 10–16) significantly expanded scope to capture emerging regulatory challenges: therapeutic vaping products (a new regulatory frontier) and personal care products (toothpaste, moisturiser, lice treatment, weight loss products) that were increasingly being marketed with therapeutic claims. The addition of a complex transitional regime for items 13–16—protecting existing medical device registrations until 2031—shows the legislation has evolved from a simple declaratory instrument into a mechanism for managing regulatory reclassification of established products."},"complexity_factors":["Multiple nested definitions: 12 defined terms in section 4, with 8 of those defined by reference to other instruments (the Regulations or MD Regulations)","Cross-referencing web: definitions rely on the parent Act, the Therapeutic Goods Regulations 1990, and the Therapeutic Goods (Medical Devices) Regulations 2002","Conditional transitional provisions in section 6 with layered exceptions: a general rule (subsection 2), an override (subsection 3), and specific date triggers (1 January 2026 vs 1 January 2031)","Technical product classifications requiring scientific/medical knowledge to interpret (e.g., 'viable tissues,' 'principal intended action through chemical or pharmacological means')","Schedule 1 mixes specific product categories with functional descriptions that require regulatory expertise to apply"],"plain_english_summary":"This Declaration clarifies which products are not “medical devices” under Australia’s Therapeutic Goods Act by listing 16 specific categories, resolving overlap with medicines, disinfectants and other regulated goods. It affects manufacturers, importers and healthcare providers by directing them to the correct regulatory pathway and changes how products are approved, monitored and labeled. A 2025 amendment gives a temporary grace period (to 2031) for certain items already registered as devices to remain on that pathway."},"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":true,"description":"Yes. Section 5 narrows the Act’s medical‑device coverage by expressly excluding the classes listed in Schedule 1 from being 'medical devices' for the Act’s purposes. Section 6 creates transitional arrangements for items 13–16 that were on the Register immediately before a later amendment, deferring the exclusion’s practical effect until registration/listing or 1 January 2031 (with an option to treat them as excluded from 1 January 2026). This shifts which products fall inside the medical‑device regulatory perimeter and when that change takes effect."},"complexity_factors":["Extensive cross-references to the Therapeutic Goods Act 1989, the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002 (definitions and scope depend on other instruments).","Schedule 1 lists 16 heterogeneous classes (from human/animal tissues to vaping products to disinfectants) with technical distinctions (e.g. 'principal intended action', 'single integral product', 'not reusable').","Transitional, saving and phased application rules (section 6) create date-based and condition-based exceptions for goods already on the Register, adding temporal complexity.","Multiple defined terms reused from other instruments (e.g. therapeutic vaping device/accessory/substance; fungicide/virucide/sterilant) increase interpretive dependency on external definitions.","Potential borderline cases where product form, marketing claims, or principal intended action determine regulatory status, creating room for factual and legal disputes.","Operational impacts on registration/listing processes (Part 3‑2) and compliance planning for industry stakeholders."],"plain_english_summary":"This Declaration lists specific articles (Schedule 1) that are, for the purposes of the Therapeutic Goods Act 1989, not to be treated as medical devices. That mechanically removes those items from the TGA’s medical-device regulatory regime and therefore affects manufacturers, importers, suppliers, registrants and anyone seeking registration or listing. The instrument cross-references existing Regulations and sets transitional rules for certain items previously on the Register, shifting compliance responsibilities and the timing of when products must be registered or listed."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-articles-that-are-not-medical-devices-declaration-2023","history":"/api/acts/therapeutic-goods-articles-that-are-not-medical-devices-declaration-2023/history","analysis":"/api/acts/therapeutic-goods-articles-that-are-not-medical-devices-declaration-2023/analysis","conflicts":"/api/acts/therapeutic-goods-articles-that-are-not-medical-devices-declaration-2023/conflicts","importantCases":"/api/acts/therapeutic-goods-articles-that-are-not-medical-devices-declaration-2023/important-cases","documents":"/api/acts/therapeutic-goods-articles-that-are-not-medical-devices-declaration-2023/documents"}}