{"id":"F2019L00972","name":"Therapeutic Goods (Breast Implants Information) Specification 2019","slug":"therapeutic-goods-breast-implants-information-specification-2019","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":440170,"registerId":"F2019L00972-fast-fetch-1775955904577","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Breast Implants Information) Specification 2019","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\n---\n\n?xml version=\"1.0\" encoding=\"utf-8\" standalone=\"no\"?>\n\n![Commonwealth Coat of Arms of Australia](image.001.jpeg)\n\n \n\nTherapeutic Goods (Breast Implants Information) Specification 2019\n\n \n\nI, John Skerritt, as delegate of the Minister for Health, make the following specification.\n\nDated 9 July 2019        \n\nAdjunct Professor John Skerritt\n\nDeputy Secretary\n\nHealth Products Regulation Group\n\nDepartment of Health\n\n \n\n \n\nContents\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Definitions\n\n5  Therapeutic goods information\n\nSchedule 1—Specified kinds of therapeutic goods information\n\n \n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Breast Implants Information) Specification 2019.\n\n2  Commencement\n\n (1) Each provision of this instrument specified in column 1 of the table commences, or is taken to have commenced, in accordance with column 2 of the table. Any other statement in column 2 has effect according to its terms.\n\n \n\n- Commencement information\n- Column 1 Column 2 Column 3\n- Provisions Commencement Date/Details\n- 1. The whole of this instrument The day after this instrument is registered.\n\n\nNote:  This table relates only to the provisions of this instrument as originally made. It will not be amended to deal with any later amendments of this instrument.\n\n (2) Any information in column 3 of the table is not part of this instrument. Information may be inserted in this column, or information in it may be edited, in any published version of this instrument.\n\n3  Authority\n\n  This instrument is made under subsection 61(5D) of the Therapeutic Goods Act 1989.\n\n4  Definitions\n\nNote: A number of expressions used in this instrument are defined in section 3 of the Act, including the following:\n\n1.       device number;\n2.       manufacturer, of a medical device;\n3.       medical device;\n4.       Register;\n\n\n(e) sponsor; and\n\n(f) therapeutic goods.\n\n  In this instrument:\n\nAct means Therapeutic Goods Act 1989.\n\nbreast implant device means a medical device which is intended for the purpose of implantation as a breast implant, mammary implant or tissue expander (however described).\n\nrelevant regulatory action means one or more of the following actions by a delegate of the Secretary:\n\n (a) giving notice of a proposal to suspend a kind of medical device from the Register under Part 4-6 of the Act;\n\n (b) giving notice of a proposal to cancel the entry of a kind of medical device from the Register under Part 4-6 of the Act;\n\n (c) the imposition of new conditions on including a kind of device in the Register under section 41FP of the Act.\n\ntherapeutic goods information has the meaning given by subsection 61(1) of the Act.\n\n5  Therapeutic goods information\n\nThe kinds of therapeutic goods information set out in column 2 of the table in Schedule 1 to this instrument, as described in column 3 of the corresponding item, are specified for the purpose of subsection 61(5C) of the Act.\n\nNote: Kinds of therapeutic goods information specified under subsection 61(5D) of the Act may be released by the Secretary to the public under subsection 61(5C).\n\n\n\n\nSchedule 1—Specified kinds of therapeutic goods information\n\nNote: See section 5.\n\n \n\n- Kinds of therapeutic goods information\n- Column 1 Column 2 Column 3\n- Item Information Description\n- 1 therapeutic goods the name (including the brand name), and device number (commonly known as the ARTG number), of the breast implant device that is the subject of relevant regulatory action (the relevant goods), and any other information necessary to identify the relevant goods\n- 2 sponsor the name of the sponsor of the relevant goods\n- 3 manufacturer the name of the manufacturer of the relevant goods\n- 4 relevant regulatory action details of the relevant regulatory action in relation to the relevant goods, including the date that the decision in relation to the relevant regulatory action was made\n\n\n \n","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":false,"description":"This instrument does not expand the Act’s substantive regulatory powers. It specifies which categories of information about breast implant devices may be released under existing disclosure powers in the Act, limited to identification of the device, sponsor, manufacturer and particulars of the relevant regulatory action (see s5 and Schedule 1)."},"complexity_factors":["Cross-reference to the Therapeutic Goods Act 1989 for legal effect and the definition of 'therapeutic goods information' (made under s.61(5D) of the Act) (see s3 of the instrument).","Instrument-level definitions that narrow scope (e.g. 'breast implant device' and 'relevant regulatory action') require reading s4 together with Schedule 1 to understand applicability (see s4; Schedule 1).","Delegated discretion: release tied to actions by ‘a delegate of the Secretary’ (definition of 'relevant regulatory action'), creating administrative discretion about when the specified information is published (see s4 definition of relevant regulatory action and s5).","Limited list of specified items (device identity, sponsor, manufacturer, action details/date) simplifies compliance but creates reputational and disclosure risk for affected parties (see Schedule 1 items 1–4).","Operational dependence on the delegate’s procedural steps (notice/proposal/condition imposition) means timing and triggers for disclosure are procedural rather than automatic (see Schedule 1 and s5)."],"plain_english_summary":"This specification says what information about breast implant medical devices may be published when a delegate of the Secretary takes a regulatory action concerning those devices. It authorises public disclosure of the device identity (brand and ARTG number), the sponsor and manufacturer, and details and date of the regulatory action. It affects sponsors and manufacturers by exposing identifying information to the public and gives regulators a clear list of releasable items."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The legislation remains tightly focused on its original purpose: specifying what breast implant information can be released when regulatory action is taken. It has not expanded beyond this narrow transparency function."},"complexity_factors":["Very short instrument — only 5 sections plus a single schedule","Minimal defined terms — only 4 definitions specific to this instrument (Act, breast implant device, relevant regulatory action, therapeutic goods information), plus references to 6 standard terms defined in the parent Act","No nested exceptions or conditional logic — the operative provision (section 5) is a straightforward directive","Single cross-reference — only references subsection 61(5D) of the Therapeutic Goods Act 1989 as the enabling power","Simple tabular structure in Schedule 1 with only 4 items of information specified","No temporal limitations, sunset clauses, or transitional provisions beyond standard commencement"],"plain_english_summary":"This law lets the Therapeutic Goods Administration publicly name specific breast implants and related details when it proposes regulatory action (suspension, cancellation or new conditions). It affects patients, clinicians and manufacturers by increasing transparency about products under safety review. Prompted by concerns linking some implants to BIA-ALCL, the change aims to help people make informed choices and hold sponsors and makers accountable."},"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-breast-implants-information-specification-2019","history":"/api/acts/therapeutic-goods-breast-implants-information-specification-2019/history","analysis":"/api/acts/therapeutic-goods-breast-implants-information-specification-2019/analysis","conflicts":"/api/acts/therapeutic-goods-breast-implants-information-specification-2019/conflicts","importantCases":"/api/acts/therapeutic-goods-breast-implants-information-specification-2019/important-cases","documents":"/api/acts/therapeutic-goods-breast-implants-information-specification-2019/documents"}}