{"id":"F2017L01114","name":"Therapeutic Goods Information (Medical Devices) Specification 2017","slug":"therapeutic-goods-information-medical-devices-specification-2017","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":97004,"registerId":"commonwealth-F2017L01114-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods Information (Medical Devices) Specification 2017","content":"![C:\\Users\\carteb\\Desktop\\logo stacked-300dpi-officialsize-.png](image.001.png)\n\nTherapeutic Goods Information (Medical Devices) Specification 2017\n\nTherapeutic Goods Act 1989\n\nI, JOHN SKERRITT a delegate of the Minister for Health, make this Specification, under subsection 61(5AB) of the Therapeutic Goods Act 1989.\n\nDated 29 August 2017\n\n(signed by)\n\nJOHN SKERRITT\n\nDelegate of the Minister for Health\n\n  \n\n1 Name of Specification\n\nThis Specification is the Therapeutic Goods Information (Medical Devices) Specification 2017.\n\n2 Commencement\n\nThis Specification commences on the day after it is registered.\n\n3 Definitions\n\nIn this Specification:\n\n> Act means the Therapeutic Goods Act 1989.\n\n> Specified medical device means an implantable medical device or an active implantable medical device\n\n> Note: ‘active implantable medical device’ has the same meaning as in the Dictionary to the Therapeutic Goods (Medical Devices) Regulations 2002;\n\n> ‘implantable medical device’ has the same meaning as in the Dictionary to the Therapeutic Goods (Medical Devices) Regulations 2002;\n\n> ‘medical device’ has the same meaning as in s 41BD of the Act; and\n\n> ‘therapeutic goods information’ has the same meaning as in s 61 of the Act. This information is expressly limited to information held by the Department; it does not include information that the Department does not hold, for example, information held only by a manufacturer.\n\n4 Specification\n\nFor subsection 61(5AA) of the Act, Schedule 1 specifies the kinds of persons in column 1 to whom the kinds of therapeutic goods information specified in column 2 can be released for the purposes specified in column 3.\n\n> Note: The therapeutic goods information specified in Schedule 1 can be released by the Secretary to a person specified in Schedule 1 under subsection 61(5AA) of the Act.\n\nSchedule 1 Specification\n\n(section 4)\n\n|     | Column 1(Kinds of person)                                                                                                                   | Column 2(Kinds of therapeutic goods information)                                                                                                                                                                                                         | Column 3(Purposes)                                                                                                                                                                                  |\n| --- | ------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| 1   | Any person who has been or may have been implanted with a specified medical device.                                                         | Information regarding the materials, including their chemical and physical properties, used in the production of the specified medical device (or generally used in the type of specified medical device), including possible residues of the materials. | For the purpose of informing a person about a specified medical device that has been or may have been implanted in that person.                                                                     |\n| 2   | Any medical practitioner who has treated or is treating any person who has been or may have been implanted with a specified medical device. | Information regarding the materials, including their chemical and physical properties, used in the production of the specified medical device (or generally used in the type of specified medical device), including possible residues of the materials. | For the purpose of informing (a) that medical practitioner about a specified medical device that has been or may have been implanted in a patient of the medical practitioner, or (b) that patient. |","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":2,"scope_assessment":{"changed":false,"description":"This Specification implements subsection 61(5AA) by identifying the classes of persons and kinds of Department-held information that may be released (s4, Schedule 1). It limits scope to information the Department already holds and does not expand the universe of disclosable material to include manufacturer-only records (s3 note)."},"complexity_factors":["Narrow subject matter: limited to implantable and active implantable devices (s3).","Specific kinds of information: focuses on materials, chemical/physical properties and possible residues (Schedule 1, Column 2).","Clear recipient and purpose matrix: two recipient classes and defined purposes reduce ambiguity (Schedule 1, Columns 1–3).","Delegated decision-maker: release occurs under Secretary/Delegate power pursuant to subsection 61(5AA) and made under s61(5AB) (instrument heading and s4 note).","Relies on departmental holdings only; excludes information held solely by manufacturers (s3 note), creating a practical data availability constraint.","Lacks procedural detail: no timetable, fee, application process or appeal mechanism is set out in the Specification (implicit from instrument text).","Cross-references to the Act and Regulations for key definitions increase dependence on other instruments for full meaning (s3)."],"plain_english_summary":"This Specification sets out who may be given material-composition information the Department holds about implantable and active implantable medical devices and why. It authorises the Secretary to disclose information on materials (including possible residues) to persons implanted or possibly implanted and to their treating medical practitioners, for the purpose of informing patients or clinicians. The Specification is limited to information the Department already holds and does not require manufacturers to supply material the Department does not have."},"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"},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"This specification appears tightly focused on its original purpose: enabling disclosure of implant material information to patients and treating doctors. The scope is narrow and specific, matching the apparent intent of subsection 61(5AB) of the Therapeutic Goods Act 1989."},"complexity_factors":["Very short document (approximately 1 page of substantive content)","Only 4 defined terms, all referencing external definitions rather than creating new ones","Simple tabular structure with 3 columns and 2 rows of operative provisions","No nested exceptions or conditional logic — just two straightforward permission rules","No cross-references beyond pointing to the enabling Act and external regulations for definitions"],"plain_english_summary":"This law lets the Department of Health release technical information about implantable and active implantable medical devices (materials, chemical makeup, manufacturing residues) to patients and their treating doctors. \n\nIt matters because those details can affect care—e.g., managing allergic reactions or planning MRIs—but the Department can only share information it actually holds from manufacturers."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-information-medical-devices-specification-2017","history":"/api/acts/therapeutic-goods-information-medical-devices-specification-2017/history","analysis":"/api/acts/therapeutic-goods-information-medical-devices-specification-2017/analysis","conflicts":"/api/acts/therapeutic-goods-information-medical-devices-specification-2017/conflicts","importantCases":"/api/acts/therapeutic-goods-information-medical-devices-specification-2017/important-cases","documents":"/api/acts/therapeutic-goods-information-medical-devices-specification-2017/documents"}}