{"id":"F2019L01034","name":"Therapeutic Goods (Australian Breast Device Registry) Specification 2019","slug":"therapeutic-goods-australian-breast-device-registry-specification-2019","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":440188,"registerId":"F2019L01034-fast-fetch-1775955913150","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Australian Breast Device Registry) 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 (Australian Breast Device Registry) Specification 2019\n\nI, Ben Noyen, as delegate of the Minister for Health, make the following specification.\n\nDated 26 July 2019\n\nBen Noyen\n\nActing First Assistant Secretary\n\nMedical Devices and Product Quality Division\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  Release of therapeutic goods information\n\nSchedule 1—Therapeutic goods information\n\n \n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Australian Breast Device Registry) 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day after this instrument is registered.\n\n\nNote:  This table relates only to the provisions of this instrument as originally made.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(5AB) 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\n(a) device number;\n\n(b) manufacturer;\n\n(c) Register;\n\n(d) Secretary; and\n\n(e) therapeutic goods.\n\n  In this instrument:\n\nABDR means the Australian Breast Device Registry administered by Monash University (ABN 12 377 614 012).\n\nAct means the Therapeutic Goods Act 1989.\n\nbreast device means one of the following medical devices, or kinds of medical device:\n\n (a) breast implant;\n\n (b) acellular dermal matrix;\n\n (c) tissue expander.\n\ntherapeutic goods information has the meaning given by subsection 61(1) of the Act.\n\n5  Release of therapeutic goods information\n\nFor subsection 61(5AA) of the Act, in relation to each item, the kinds of therapeutic goods information specified in column 2 of the table in Schedule 1 to this instrument, may be released to the body specified in column 3, for the purposes specified in column 4 of that table.\n\nNote: Under subsection 61(5AA) of the Act, the Secretary may release to a body that is specified under subsection 61(5AB), specified kinds of therapeutic goods information for a specified purpose.\n\n\n\n\nSchedule 1—Therapeutic goods information\n\nNote: See section 5.\n\n \n\n- Therapeutic goods information that may be released\n- Column 1 Column 2 Column 3 Column 4\n- Item Information Body Purposes\n- 1 in relation to a breast device, the following information on an annual basis:(a) the name of the breast device;(b) the classification of the breast device;(c) the model number of the breast device;(d) the device number (commonly known as the ARTG number) of the breast device;(e) the manufacturer of the breast device;(f) the raw sales data relating to the breast device ABDR both of the following:(a) determining the number of devices registered with the ABDR as a proportion of those supplied in the Australian market (the capture rate); and(b) publishing the aggregate capture rate in the annual report of the ABDR\n\n\n \n","sortOrder":0}],"analysis":{"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"},"flash_summary":{"complexity_score":2,"scope_assessment":{"changed":false,"description":"This instrument does not expand the statutory release power; it specifies which kinds of therapeutic goods information about breast devices may be released to the ABDR and for what purposes under subsection 61(5AA)/(5AB) of the Act. It limits releases to a defined set of identifying and sales data on an annual basis for calculating and publishing the registry's capture rate (see section 5 and Schedule 1)."},"complexity_factors":["Narrow, single-purpose scope: annual release of specified breast-device data to one named recipient (section 5; Schedule 1).","Relies on statutory release powers and definitions in the Therapeutic Goods Act — particularly subsections 61(5AA) and 61(5AB) and the Act's definitions (see section 3 notes).","Data types include device identifiers and raw sales data, creating practical compilation, record-matching and data-handling tasks for the Secretary and ABDR (Schedule 1).","Delegated instrument and administrative discretion: made by a Ministerial delegate and executed under the Secretary's release authority (instrument header; section 5).","Operational timing: annual cadence requires coordination between regulator, suppliers and the registry for reporting and capture-rate calculation (Schedule 1)."],"plain_english_summary":"**What this does:** This instrument allows the Secretary to share specified identifying and sales data about breast devices held under the Therapeutic Goods Act with the Australian Breast Device Registry (ABDR). \n\n**Who it affects and why it matters:** It affects device manufacturers/suppliers and the ABDR by enabling annual data transfers so the ABDR can calculate its registry \"capture rate\" and publish that aggregate capture rate in its annual report (see section 5 and Schedule 1)."},"kimi_summary":{"content_quality":"ok","complexity_score":2,"scope_assessment":{"changed":false,"description":"The instrument remains tightly scoped to its original purpose. It authorises only the specific information release necessary for the ABDR to calculate capture rates and report aggregate data. There is no evidence of scope creep; the instrument does exactly what its title and enabling provision suggest."},"complexity_factors":["Very short instrument — only 5 sections plus a single-item schedule","Only 4 defined terms in the instrument itself (ABDR, Act, breast device, therapeutic goods information), with 5 additional terms incorporated by reference from the parent Act","Single operative provision (section 5) with straightforward tabular format in Schedule 1","No nested exceptions, conditional logic, or cross-references beyond the basic empowering provision (s 61(5AB) of the Therapeutic Goods Act 1989)","Clear purpose-based limitation — information release is restricted to calculating and publishing capture rates"],"plain_english_summary":"This law lets the government share specified information about breast implants and related devices with Monash University's Australian Breast Device Registry once a year so the registry can compare what it tracks to what’s sold (the \"capture rate\"). It affects patients, device manufacturers and suppliers, Monash (ABDR) and the TGA, and is intended to strengthen device safety monitoring and transparency."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-australian-breast-device-registry-specification-2019","history":"/api/acts/therapeutic-goods-australian-breast-device-registry-specification-2019/history","analysis":"/api/acts/therapeutic-goods-australian-breast-device-registry-specification-2019/analysis","conflicts":"/api/acts/therapeutic-goods-australian-breast-device-registry-specification-2019/conflicts","importantCases":"/api/acts/therapeutic-goods-australian-breast-device-registry-specification-2019/important-cases","documents":"/api/acts/therapeutic-goods-australian-breast-device-registry-specification-2019/documents"}}