{"id":"F2020L00463","name":"Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020","slug":"therapeutic-goods-medical-devices-specified-articles-instrument-2020","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":101046,"registerId":"commonwealth-F2020L00463-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\nThis instrument is the Therapeutic Goods (Medical Devices—Specified Articles) Instrument 2020.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\nThis instrument is made under subsection 41BD(2B) of the Therapeutic Goods Act 1989.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\nNote 1: A number of expressions used in this instrument are defined in subsection 3(1) of the Act including:\n\n (a) conformity assessment certificate;\n (b) health practitioner;\n (c) included in the Register;\n (d) listed goods;\n (e) manufacturer;\n (f) medical device;\n (g) medicine;\n (h) Register;\n (i) registered goods;\n (j) supply;\n (k) therapeutic goods.\n\nNote 2: Other grammatical forms of a defined word have a corresponding meaning (see section 18A of the Acts Interpretation Act 1901), for example, manufacturer and manufacture.\n\nIn this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\n> MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.\n\nrelevant practitioner means a health practitioner, or other person suitably trained or qualified who is acting on the instruction, or at the request, of a health practitioner.\n\ntherapeutic cannabis vaping good has the same meaning as in the MD Regulations.\n\n> therapeutic vaping device has the same meaning as in the MD Regulations.\n\ntherapeutic vaping device accessory has the same meaning as in the MD Regulations.","sortOrder":2},{"sectionNumber":"5","sectionType":"section","heading":"Classes of articles specified to be medical devices","content":"#### 5 Classes of articles specified to be medical devices\n\nThe classes of instruments, apparatus, appliances, software, implants, reagents, materials and other articles mentioned in Schedule 1 are specified to be medical devices for the purposes of paragraph 41BD(1)(ab) of the Act.\n\nNote: The meaning of medical device in section 41BD of the Act includes any article that is included in a class of articles specified under subsection 41BD(2B).","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 therapeutic goods in items 8 to 14 of the table in Schedule 1 that, immediately before the commencement of the Therapeutic Goods (Medical Devices—Specified Articles) Amendment Instrument 2025, were registered goods or listed goods.\n (2) Items 8 to 14 of the table in Schedule 1, as inserted by Schedule 1 to the Therapeutic Goods (Medical Devices—Specified Articles) Amendment Instrument 2025, do not apply to the therapeutic goods mentioned in subsection (1) until the earlier of:\n (a) the date on which the goods are included in the Register as a kind of medical device; and\n (b) 1 January 2031.\n (3) Despite subsection (2), the therapeutic goods mentioned in subsection (1) may be dealt with in accordance with the amendments made by the Therapeutic Goods (Medical Devices—Specified Articles) Amendment Instrument 2025, including for the purposes of the following:\n (a) an application for a conformity assessment certificate;\n (b) an application for inclusion in the Register as a kind of medical device;\n (c) any applicable provisions in Part 4-4 of the Act in relation to conformity assessment certificates and Part 4-5 in relation to the inclusion of kinds of medical devices in the Register.\n\n \n\nSchedule 1—Specified classes of articles that are medical devices\n\nNote: See section 5.\n\n```html\n

Specified classes of articles

Column 1

Column 2

Item

Specified class

1

articles that are non-sterile personal protective equipment or safety apparel (including but not limited to aprons, face masks, gloves, goggles, gowns and visors) intended, by the person under whose name the articles are or are to be supplied, to be used for the prevention of the transmission of disease between persons, including where that intention may be ascertained from the articles being represented as suitable for use in surgery, or clinical, medical or other health services

2

articles (whether used alone or in combination, and including the software necessary for their proper application) that:

(a) are intended by the person under whose name the articles are, or are to be, supplied to be used for the examination of a specimen derived from a human body for the purpose of:

(i) predicting the susceptibility or predisposition of persons to a disease or ailment; or

(ii) testing for pregnancy in persons; and

(b) do not achieve their principal intended action in or on the human body by pharmacological, immunological or metabolic means, but that may be assisted in their function by such means

3

bedding, clothing, towels and other articles made principally of fabric that are:

(a) intended, by the person under whose name the articles are or are to be supplied, to be used primarily on, or in close contact with, the human body; and

(b) represented expressly to be effective against the virus that causes coronavirus disease (COVID-19);

other than articles that are mattresses, household furnishings, furniture or articles specified in item 1

3A

materials and other articles that are intended, by the person under whose name the articles are or are to be supplied, to be used by a relevant practitioner for the direct restoration of teeth, including but not limited to:

(a) amalgam;

(b) composite resins and respective bonding systems;

(c) core build-up materials;

(d) crown forms;

(e) fibre or metal preformed posts;

(f) fibre reinforcement materials;

(g) fissure sealants;

(h) glass ionomers;

(i) liners and bases;

(j) resin-modified glass ionomers;

(k) temporary crown or bridge materials

3B

materials and articles that are intended, by the person under whose name the articles are or are to be supplied, to be used by a relevant practitioner for the indirect restoration of teeth, including but not limited to:

(a) ceramic;

(b) crown forms;

(c) metal alloy;

(d) temporary crown or bridge materials

3C

materials and other articles that are intended, by the person under whose name the articles are or are to be supplied, to be used by a relevant practitioner in the manufacture of externally-applied orthopaedic devices, including but not limited to:

(a) fibreglass bandages used in the manufacture of splints or orthoses;

(b) software;

(c) thermoplastic sheeting used in the manufacture of splints or orthoses

3D

materials and other articles that are intended, by the person under whose name the articles are or are to be supplied, to be used by a relevant practitioner to manufacture non-implantable dental appliances, including but not limited to:

(a) acrylic;

(b) denture repair or reline materials;

(c) metal alloy used in casting;

(d) orthodontic components (such as bands, brackets, chains, elastics, ligature ties, separators and wire);

(e) palate expanders;

(f) preformed acrylic teeth;

(g) preformed clasps;

(h) software;

(i) thermoplastic;

(j) wrought wire used in the manufacture of clasps or retainers

3E

materials and other articles that are intended, by the person under whose name the articles are or are to be supplied, to be used by a relevant practitioner to obtain dental impressions

4

substances that are intended, by the person under whose name the products are or are to be supplied, specifically to be used for disinfecting a medical device

5

substances that are intended, by the person under whose name the products are or are to be supplied, to be used only to clean a medical device (other than contact lenses) by means of physical action

6

substances that are intended, by the person under whose name the products are or are to be supplied, specifically to be used for disinfecting, cleaning, rinsing or hydrating contact lenses

7

articles or components that are, or are likely to be taken to be, for use in the manufacture of therapeutic vaping devices, therapeutic vaping device accessories or therapeutic cannabis vaping goods, including but not limited to the following:

(a) mouthpieces;

(b) heating elements, for example, coils;

(c) batteries;

(d) lights;

(e) casements;

other than bolts, nuts, screws, or other fasteners

8

locking solutions to be used in vascular access devices that are intended, by the person under whose name the articles are, or are to be, supplied, to be used solely to maintain the patency of the device

9

substances generated by ozone generators that are intended, by the person under whose name the substances are, or are to be supplied, to be used in:

(a) sanitising or disinfecting another medical device, or medical equipment; or

(b) cleaning of the oral cavity

10

pre-filled saline flush syringes where the saline is intended, by the person under whose name the articles are, or are to be, supplied, to be used solely to maintain the patency, or to flush the lumen, of another medical device

11

weight loss treatments that are ingested into the body and that achieve their principal intended action only by means of physical action

12

head or body lice treatments that achieve their principal intended action only by means of physical action

13

toothpastes and other dentifrices that achieve their principal intended action only by means of physical action

14

moisturisers and emollients that achieve their principal intended action only by means of physical action

\n```","sortOrder":4}],"analysis":{"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"},"flash_summary":{"complexity_score":7,"scope_assessment":{"changed":true,"description":"The instrument's scope was expanded by a 2025 amendment that inserted items 8–14 in Schedule 1 (see s5 and Schedule 1 as amended). Section 6(1)–(3) establishes transitional rules: goods that were registered or listed immediately before the 2025 amendment are not subject to the new items 8–14 until they are included in the Register as a kind of medical device or until 1 January 2031, whichever is earlier, but those goods may nevertheless be the subject of conformity‑assessment applications and Register inclusion processes under the amended framework."},"complexity_factors":["Extensive cross‑references to the Therapeutic Goods Act and MD Regulations, creating multi‑instrument dependencies (see s3; s4 definitions; s5).","Large Schedule with many narrowly‑worded classes and subitems (technical lists of dental, orthopaedic, diagnostic and consumer articles) increasing categorical granularity (see Schedule 1 items 1–7, 3A–3E).","Inclusion of both tangible articles and embedded/ancillary software, and reliance on the supplier's stated ‘intended use’ (see Schedule 1 items 2, 3C, 3D).","Transitional and saving provisions that defer application for certain goods but permit processing for conformity assessment and Register inclusion (see s6(1)–(3)), adding temporal and procedural complexity.","Delegated rule‑making/administrative reach under subsection 41BD(2B) (authority for instrument) introduces administrative discretion in implementation (see s3).","Numerous carve‑outs and exceptions (for example household furnishings excluded from item 3; standard fasteners excluded from item 7) require fine‑grained factual assessments by regulators and suppliers (see Schedule 1 items 1, 3, 7).","Interaction with existing listed/registered goods regimes — potential overlap, conversion and compliance cost questions for businesses that previously relied on different regulatory status (see s6)."],"plain_english_summary":"This instrument declares the classes of articles listed in Schedule 1 to be medical devices under the Therapeutic Goods Act. It captures items such as non‑sterile PPE, in vitro diagnostic articles, dental and orthopaedic materials, disinfectants/cleaners, vaping components and certain consumer treatments, so that manufacturers, importers and suppliers must meet device registration, conformity‑assessment and other regulatory obligations. A 2025 amendment adds items 8–14 but delays applying those additions to goods that were registered or listed before the amendment until inclusion in the Register or 1 January 2031, while allowing conformity assessment and registration processing in the meantime."},"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":true,"description":"The instrument has grown significantly from its original 2020 scope. Initially focused on PPE, diagnostic tests, and COVID-19 fabric claims (items 1–3), it has expanded through amendments to capture: dental materials (3A–3E), therapeutic vaping components (7), vascular maintenance products (8, 10), ozone substances (9), and physical-action consumer products (11–14). The 2025 amendments (referenced in section 6) added items 8–14, effectively doubling the Schedule's length and extending regulation into areas like weight loss treatments, lice treatments, toothpaste, and moisturisers—products traditionally sold as cosmetics or general consumer goods. The inclusion of therapeutic vaping components also represents a response to emerging nicotine and cannabis delivery technologies not contemplated in the original instrument."},"complexity_factors":["Multiple nested definitions: 'relevant practitioner' depends on 'health practitioner' from the parent Act, and three vaping-related terms are defined by reference to separate MD Regulations","Conditional logic in items: many entries require dual conditions—specific intended use AND representation by the supplier (e.g., item 3 requires both close body contact AND express COVID-19 claims)","Cross-referencing structure: the instrument operates under subsection 41BD(2B) of the Act and incorporates definitions from both the Act and the Therapeutic Goods (Medical Devices) Regulations 2002","Transitional provisions with layered exceptions: section 6 creates a grace period with an 'earlier of' test (registration date vs. 1 January 2031) plus an override allowing early compliance activities","Exclusion clauses within items: item 7 excludes 'bolts, nuts, screws, or other fasteners'; item 3 excludes mattresses and furniture; item 5 excludes contact lenses from the cleaning provision","Technical specificity: items 3A–3E contain extensive non-exhaustive lists of dental and orthopaedic materials (amalgam, composite resins, fibre reinforcement, thermoplastic sheeting, etc.)"],"plain_english_summary":"This instrument names specific products that count as “medical devices” under the Therapeutic Goods Act—bringing otherwise ordinary goods (PPE, dental and orthopaedic materials, disinfectants, some diagnostic tests, vaping components used therapeutically, etc.) into the regulated regime. That subjects manufacturers and suppliers to safety testing and Register listing, limits use to relevant health practitioners in many cases, and protects patients. A transitional grace period (to 2031 for later-listed items) gives existing suppliers time to comply."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-medical-devices-specified-articles-instrument-2020","history":"/api/acts/therapeutic-goods-medical-devices-specified-articles-instrument-2020/history","analysis":"/api/acts/therapeutic-goods-medical-devices-specified-articles-instrument-2020/analysis","conflicts":"/api/acts/therapeutic-goods-medical-devices-specified-articles-instrument-2020/conflicts","importantCases":"/api/acts/therapeutic-goods-medical-devices-specified-articles-instrument-2020/important-cases","documents":"/api/acts/therapeutic-goods-medical-devices-specified-articles-instrument-2020/documents"}}