{"id":"F2020L01150","name":"Therapeutic Goods (Medical Devices—Excluded Purposes) Specification 2020","slug":"therapeutic-goods-medical-devices-excluded-purposes-specification-2020","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":113561,"registerId":"commonwealth-F2020L01150-current","compilationNumber":null,"startDate":"2026-04-03","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Name","content":"#### 1 Name\n\n This instrument is the Therapeutic Goods (Medical Devices—Excluded Purposes) Specification 2020.","sortOrder":0},{"sectionNumber":"3","sectionType":"section","heading":"Authority","content":"#### 3 Authority\n\n This instrument is made under section 41BEA of the Therapeutic Goods Act 1989.","sortOrder":1},{"sectionNumber":"4","sectionType":"section","heading":"Definitions","content":"#### 4 Definitions\n\n> Note: A number of expressions used in this instrument are defined in subsection 3(1) of the Act, including the following:\n\n (a) medical device; and\n (b) State.\n In this instrument:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> Class 1 IVD medical device has the same meaning as in the Regulations.\n\n> Class 2 IVD medical device has the same meaning as in the Regulations.\n\n> Class 3 IVD medical device has the same meaning as in the Regulations.\n\n> Class 4 IVD medical device has the same meaning as in the Regulations.\n\n> government health screening program means a health screening program that is conducted, approved or funded by the Commonwealth or a State.\n\n> Note: State is defined in subsection 3(1) of the Act as including the Australian Capital Territory and the Northern Territory.\n\n> IVD medical device for self-testing has the same meaning as in the Regulations.\n\n> Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> SARS-CoV-2, or severe acute respiratory syndrome coronavirus 2, means the virus that causes coronavirus disease (COVID-19).\n\n> Note: Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the name given by the International Committee on Taxonomy of Viruses to the virus that causes coronavirus disease (COVID-19).\n\n> serious disease has the same meaning as in the Regulations.","sortOrder":2},{"sectionNumber":"4A","sectionType":"section","heading":"Excluded purposes—Class 1 IVD medical devices","content":"#### 4A Excluded purposes—Class 1 IVD medical devices\n\n (1) This section applies in relation to medical devices that are:\n (a) IVD medical devices for self-testing; and\n (b) Class 1 IVD medical devices; and\n (c) not intended to be used exclusively for testing to monitor a disease or condition that has been diagnosed by a suitably qualified health professional; and\n (d) not intended exclusively for export; and\n (e) not intended to be used exclusively for testing as part of a government health screening program.\n (2) The purposes mentioned in Part 1A of Schedule 1 are specified for the purposes of paragraph 41FD(ia) and subsection 41FF(1A) of the Act.","sortOrder":3},{"sectionNumber":"5","sectionType":"section","heading":"Excluded purposes—Class 2 IVD medical devices","content":"#### 5 Excluded purposes—Class 2 IVD medical devices\n\n (1) This section applies in relation to medical devices that are:\n (a) IVD medical devices for self-testing; and\n (b) Class 2 IVD medical devices; and\n (c) not intended exclusively for export; and\n (d) not intended to be used exclusively for testing as part of a government health screening program.\n (2) The purposes mentioned in Part 1 of Schedule 1 are specified for the purposes of paragraph 41FD(ia) and subsection 41FF(1A) of the Act.","sortOrder":4},{"sectionNumber":"6","sectionType":"section","heading":"Excluded purposes—Class 3 and 4 IVD medical devices","content":"#### 6 Excluded purposes—Class 3 and 4 IVD medical devices\n\n (1) This section applies in relation to medical devices that are:\n (a) IVD medical devices for self-testing; and\n (b) Class 3 IVD medical devices or Class 4 IVD medical devices; and\n (c) not intended to be used exclusively for testing to monitor a disease or condition that has been diagnosed by a suitably qualified health professional; and\n (d) not intended exclusively for export; and\n (e) not intended to be used exclusively for testing as part of a government health screening program.\n (2) The purposes mentioned in Part 2 of Schedule 1 are specified for the purposes of paragraph 41FD(ia) and subsection 41FF(1A) of the Act.\n\n \n\nSchedule 1—Excluded purposes","sortOrder":5},{"sectionNumber":"Part 1A","sectionType":"part","heading":"Class 1 IVD medical devices","content":"## Part 1A—Class 1 IVD medical devices\n\nNote: See section 4A.\n\n```html\n

Excluded purposes

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Item

Purposes

1

testing specimens from the human body in relation to a serious disease, other than to:

(a) test for the presence of, or exposure to, any of the following pathogenic organisms or transmissible agents:

(i) chlamydia trachomatis;

(ii) hepatitis B virus;

(iii) hepatitis C virus;

(iv) herpes simplex virus type 1 and 2;

(v) human immunodeficiency virus type 1 and type 2;

(vi) seasonal influenza virus;

(vii) neisseria gonorrhoea;

(viii) treponema pallidum (syphilis); or

(b) diagnose, aid in diagnosis of, indicate the presence of, or test for the presence of markers that are precursors to, any of the following diseases or conditions, other than by genetic testing:

(i) diabetes;

(ii) kidney disease;

(iii) cardiovascular disease; or

(c) test for the presence of SARS-CoV-2 antigens or SARS-CoV-2 nucleic acid

\n```","sortOrder":6},{"sectionNumber":"Part 1","sectionType":"part","heading":"Class 2 IVD medical devices","content":"## Part 1—Class 2 IVD medical devices\n\nNote: See section 5.\n\n```html\n

Excluded purposes

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Item

Purposes

1

testing for faecal occult blood

\n```","sortOrder":7},{"sectionNumber":"Part 2","sectionType":"part","heading":"Class 3 and 4 IVD medical devices","content":"## Part 2—Class 3 and 4 IVD medical devices\n\nNote: See section 6.\n\n```html\n

Excluded purposes

Column 1

Column 2

Item

Purposes

1

testing specimens from the human body, other than to:

(a) test for the presence of, or exposure to any of the following pathogenic organisms or transmissible agents:

(i) chlamydia trachomatis;

(ii) hepatitis B virus;

(iii) hepatitis C virus;

(iv) herpes simplex virus type 1 and 2;

(v) human immunodeficiency virus type 1 and type 2;

(vi) seasonal influenza virus;

(vii) neisseria gonorrhoea;

(viii) treponema pallidum (syphilis); or

(b) diagnose, aid in diagnosis of, indicate the presence of, or test for the presence of markers that are precursors to, any of the following diseases or conditions, other than by genetic testing:

(i) diabetes;

(ii) kidney disease;

(iii) cardiovascular disease; or

(c) test for the presence of SARS-CoV-2 antigens or SARS-CoV-2 nucleic acid

\n```","sortOrder":8}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":true,"description":"The original 2020 instrument appears to have been a targeted exclusion framework for high-risk self-testing devices. However, the inclusion of SARS-CoV-2 (COVID-19) testing in Parts 1A and 2 — explicitly defined and carved out as an exception — indicates the instrument was amended to accommodate pandemic-era public health needs. This expanded the scope beyond the original intent of regulating chronic disease and STI self-testing to encompass emergency infectious disease response. The COVID-19 references are time-bound to a specific public health moment and may require further amendment as the pandemic context evolves."},"complexity_factors":["Multiple nested exceptions: The core mechanism is 'ban everything except...' with three layers of exceptions (disease type, testing method, specific pathogen list)","Cross-referencing to external definitions: 7 terms defined by reference to the Therapeutic Goods (Medical Devices) Regulations 2002 rather than defined in the instrument itself","Parallel structure with subtle variations: Sections 4A, 5, and 6 follow similar patterns but with different qualifying conditions (e.g., Class 1 and Class 3/4 both exclude 'monitoring diagnosed conditions' but Class 2 does not)","HTML table formatting in legislative text: The Schedule provisions are embedded in HTML markup, making the raw text difficult to parse","Conditional logic with multiple conjunctive requirements: Each section requires 4-5 cumulative conditions to be met before the exclusion applies"],"plain_english_summary":"This instrument bans sale of certain home-use medical tests in Australia, stopping high-risk self-tests (e.g., general cancer screening and many genetic disease tests) from being sold for lay use. It affects consumers, manufacturers, suppliers and retailers who handle self-test kits.\n\nIt preserves access to simpler/urgent home tests—common STIs, COVID-19, flu, diabetes, kidney and heart monitoring—balancing safety against timely detection."},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"The instrument does not amend primary legislation; it specifies which purposes are ‘excluded’ for the operation of paragraph 41FD(ia) and subsection 41FF(1A) of the Act (see ss4A–6). By listing device classes, specified tests and limiting conditions (not exclusively for export, government screening or monitoring a diagnosed condition), it clarifies and confines the scope of those Act provisions rather than altering the Act’s statutory text (Authority s3; Definitions s4; Schedule 1)."},"complexity_factors":["Cross‑references to the Therapeutic Goods Act 1989 and the Regulations for definitions and legal effect (see Authority s3; Definitions s4).","Class‑specific application rules and conditional exclusions that differ by risk class (Class 1: s4A(1)(a)–(e); Class 2: s5(1)(a)–(d); Classes 3 & 4: s6(1)(a)–(e)).","Detailed enumerated lists of pathogens and conditions in Schedule 1 (Part 1A and Part 2) including SARS‑CoV‑2 and a carve‑out for non‑genetic testing of certain disease markers (Schedule 1, Part 1A and Part 2).","A narrow, single‑item exclusion for Class 2 devices (faecal occult blood) in Schedule 1, Part 1, which creates asymmetry across classes.","Dependence on defined terms from the Act and Regulations (e.g. ‘IVD medical device for self‑testing’, ‘serious disease’) requiring interpretive work to apply the specification (Definitions s4)."],"plain_english_summary":"This instrument specifies which purposes count as \"excluded purposes\" for in vitro diagnostic (IVD) medical devices intended for self‑testing, separated by device class (Class 1–4). It lists specific tests and conditions (certain infectious agents, non‑genetic markers for diabetes/kidney/cardiovascular disease, SARS‑CoV‑2, and faecal occult blood) and sets applicability conditions (e.g. not solely for export, government screening or monitoring a diagnosed condition). It affects manufacturers, sponsors, importers and sellers by clarifying when particular Act provisions apply and so alters compliance and market choices."},"flash_summary_failed":{"failed":true,"reason":"Unauthenticated. Configure AI_GATEWAY_API_KEY or use a provider module. Learn more: https://ai-sdk.dev/unauthenticated-ai-gateway","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-medical-devices-excluded-purposes-specification-2020","history":"/api/acts/therapeutic-goods-medical-devices-excluded-purposes-specification-2020/history","analysis":"/api/acts/therapeutic-goods-medical-devices-excluded-purposes-specification-2020/analysis","conflicts":"/api/acts/therapeutic-goods-medical-devices-excluded-purposes-specification-2020/conflicts","importantCases":"/api/acts/therapeutic-goods-medical-devices-excluded-purposes-specification-2020/important-cases","documents":"/api/acts/therapeutic-goods-medical-devices-excluded-purposes-specification-2020/documents"}}