{"id":"F2014L01741","name":"Therapeutic Goods (Articles that are Medical Devices) Specification 2014","slug":"therapeutic-goods-articles-that-are-medical-devices-specification-2014","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"repealed","isInForce":false,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":92412,"registerId":"commonwealth-F2014L01741-current","compilationNumber":null,"startDate":"2026-04-02","status":"Repealed","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Articles that are Medical Devices) Specification 2014","content":"![](image.001.png)\n\nTherapeutic Goods (Articles that are Medical Devices) Specification 2014\n\nTherapeutic Goods Act 1989\n\nI, JOHN SKERRITT, delegate of the Secretary of the Department of Health, make this Specification under subsection 41BD(2B) of the Therapeutic Goods Act 1989.\n\nDated December 15, 2014\n\n(Signed by)\n\nJOHN SKERRITT\n\nDelegate of the Secretary of the Department of Health\n\n1 Name of Specification\n\nThis Specification is the Therapeutic Goods (Articles that are Medical Devices) Specification 2014.\n\n2 Commencement\n\nThis Specification commences on the day after it is registered.\n\n3 Articles that are medical devices\n\nFor the purposes of paragraph 41BD(1)(ab) of the Therapeutic Goods Act 1989, the following classes of instruments, apparatus, appliances, materials or other articles are specified˗˗ instruments, apparatus, appliances, materials or other articles (whether used alone or in combination, and including the software necessary for their proper application) that:\n\n(a) are intended by the person under whose name they are or are to be supplied to be used for the examination of a specimen derived from a human body for the purpose of:\n\n(i) predicting the susceptibility or predisposition of persons to a disease or ailment; or\n\n(ii) testing for pregnancy in persons; and\n\n(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.\n\n> Note\n\n> Note: 1. All legislative instruments and compilations are registered on the Federal Register of Legislative Instruments kept under the Legislative Instruments Act 2003. See http://www.frli.gov.au","sortOrder":0}],"analysis":{"kimi_summary":{"_metrics":{"model":"kimi-k2.5","source":"moonshot-batch","completionTokens":1400},"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The specification remains tightly focused on its original purpose: capturing in-vitro diagnostic devices for genetic susceptibility testing and pregnancy testing under medical device regulation. The scope has not expanded beyond these two specific classes of articles."},"complexity_factors":["Very short instrument (only 3 sections)","Minimal defined terms (relies on definitions in parent Act)","Single operative provision with clear, unambiguous criteria","No cross-references except to enabling provision in Therapeutic Goods Act 1989"],"plain_english_summary":"This law treats certain genetic susceptibility test kits and pregnancy tests (including their required software) as \"medical devices\" under Australia’s Therapeutic Goods Act. It applies when manufacturers or suppliers intend those products to predict future disease risk or detect pregnancy, provided they do not act primarily by drugs, immune responses, or metabolism.\n\nThat means affected products must meet Australian safety, quality, and performance rules before supply, protecting consumers from unreliable results."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-articles-that-are-medical-devices-specification-2014","history":"/api/acts/therapeutic-goods-articles-that-are-medical-devices-specification-2014/history","analysis":"/api/acts/therapeutic-goods-articles-that-are-medical-devices-specification-2014/analysis","conflicts":"/api/acts/therapeutic-goods-articles-that-are-medical-devices-specification-2014/conflicts","importantCases":"/api/acts/therapeutic-goods-articles-that-are-medical-devices-specification-2014/important-cases","documents":"/api/acts/therapeutic-goods-articles-that-are-medical-devices-specification-2014/documents"}}