{"id":"F2017L00965","name":"Therapeutic Goods Information (Sharing information about in-house in vitro diagnostic medical devices) Specification 2017","slug":"therapeutic-goods-information-sharing-information-about-in-house-in-vitro-diagnostic-medical-devices","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":96854,"registerId":"commonwealth-F2017L00965-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods Information (Sharing information about in-house in vitro diagnostic medical devices) Specification 2017","content":"![](image.001.png)\n\nTherapeutic Goods Information (Sharing information about in-house in vitro diagnostic medical devices) Specification 2017\n\nTherapeutic Goods Act 1989\n\nI, ADRIANA PLATONA, a delegate of the Minister for Health, make this Specification under subsection 61(5AB) of the Therapeutic Goods Act 1989.\n\nDated 25 July 2017\n\n(Signed by)\n\nADRIANA PLATONA\n\nDelegate of the Minister for Health\n\n1 Name of Specification\n\nThis Specification is the Therapeutic Goods Information (Sharing information about in-house in vitro diagnostic 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> ARTG means the Australian Register of Therapeutic Goods.\n\n> IVD medical device has the same meaning as in the MD Regulations.\n\n> in-house IVD medical device (in-house IVD) has the same meaning as in the MD Regulations.\n\n> MD Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.\n\n> NATA means the National Association of Testing Authorities, of Australia.\n\n> TGA means the Therapeutic Goods Administration, which is part of the Department of Health.\n\n4 Therapeutic goods information, persons and purposes\n\nThe kinds of therapeutic goods information, persons, bodies and purposes, mentioned in Schedule 1 are specified under subsection 61(5AB) of the Act, for the purposes of subsection 61(5AA) of the Act.\n\nSchedule 1 Specified kinds of therapeutic goods information, persons, bodies and purposes\n\n(section 4)\n\n The following kinds of therapeutic goods information, persons, bodies and purposes:\n Note 1: The following specified kinds of therapeutic goods information may be released by the Secretary under subsection 61(5AA) of the Act to the following specified bodies and kinds of persons, for the following specified purposes.\n Note 2: References in the Table below to clauses are references to clauses in the Memorandum of Understanding between the Commonwealth of Australia and NATA, in relation to In-House In Vitro Diagnostic Medical Devices, made on 2 September 2016.\n\n 1. Therapeutic goods information:\n\n The following kinds of therapeutic goods information, being information that relates to in-house IVDs and that is held by the TGA:\n\n| Item | Information | Description |\n| ---- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| (a) | Information relating to the assessment of laboratories engaged in the manufacture of in-house IVDs [clause 5.1(c)] | For example, sharing of information related to the assessment of a laboratory engaged in the manufacture of a Class 4 in-house IVD in relation to an application for inclusion in the ARTG, where the laboratory is utilising their existing NATA accreditation to support an application for inclusion. |\n| (b) | Information relating to trends in technology and laboratory practice regarding in-house IVDs, including in relation to the clinical utility, misuse or performance of in-house IVDs [clause 5.5] | For example, sharing of information for the development of guidance for industry in relation to emerging technologies. |\n| (c) | Information relating to concerns of the TGA about the performance or competence of NATA-accredited laboratories engaged in the manufacture of in-house IVDs [clauses 6.9 and 7.6] | For example, sharing of information relating to an adverse event for an in-house IVD that raises concerns with respect to the performance of the in-house IVD. |\n| (d) | The following information relating to a laboratory engaged in the manufacture of in-house IVDs:a list of all Class 1-3 in-house IVDs manufactured by the laboratory, and the date the laboratory last notified the TGA of the details of the Class 1-3 in-house IVDs that it was manufacturing at that time;a list of all Class 4 in-house IVDs manufactured by the laboratory;details of any assessments being undertaken in relation to any technical or scientific data that supports the performance of a Class 4 in-house IVD that was provided by the applicant with their application for inclusion in the ARTG; anddetails of any post-market investigations undertaken by the TGA relating to aspects of concern, including any technical or scientific data provided by a laboratory, in relation to any in-house IVDs manufactured by the laboratory; [clause 7.2]information of a kind which the laboratory is required to notify the Secretary of as part of their post market system requirements in accordance with paragraph 6A.4(2)(c) of Schedule 3 to the MD Regulations (for Class 1, 2 or 3 in-house IVDs) or paragraph 6B.5(2)(c) of Schedule 3 to the MD Regulations (for Class 4 in-house IVDs); [clause 7.3] | For example, sharing of information in relation to a notification provided to the TGA by a laboratory of their Class 1-3 in-house IVDs being manufactured, in order to assist NATA prepare for an accreditation assessment activity for that laboratory.For example, sharing of information relating to the number of Class 4 in-house IVDs manufactured by a NATA-accredited laboratory that are included in the ARTG (or are otherwise exempt from inclusion).For example, sharing of information in relation to the assessment of any technical or scientific data provided by a NATA-accredited laboratory to support their application for inclusion of a Class 4 in-house IVD in the ARTG (where the laboratory is utilising their NATA accreditation to support an application for inclusion).For example, sharing of information, including technical or scientific data, relating to a reported adverse event for a Class 4 in-house IVD that raises safety concerns with respect to the performance or competence of a NATA-accredited laboratory engaged in the manufacture of in-house IVDs. |\n\n 2. Persons and bodies:\n\n (a) NATA.\n\n 3. Purposes:\n\nTo facilitate the sharing and considering of information in the interest of public health and safety, including in particular the sharing and considering of information relating to the quality, safety or performance of in-house IVDs being manufactured by NATA-accredited laboratories.\n\n> Note\n\n> Note: 1. All legislative instruments and compilations are registered on the Federal Register of Legislation kept under the Legislation Act 2003. See http://www.frl.gov.au","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":4,"scope_assessment":{"changed":false,"description":"This Specification does not alter the statutory power to disclose information; it identifies and constrains the specific kinds of therapeutic‑goods information, the single recipient (NATA) and the permitted purposes for disclosure under subsection 61(5AB)/(5AA) of the Act (see section 4 and Schedule 1). It therefore clarifies operational scope rather than expanding or reducing the underlying statutory authority, while relying on the MD Regulations and the referenced MoU for procedural detail."},"complexity_factors":["Cross‑references to the Therapeutic Goods Act (subsections 61(5AB) and 61(5AA)) and the MD Regulations create legal interdependence (see section 4).","Reliance on a separate Memorandum of Understanding with NATA for operational clauses and cross‑references to its clause numbers increases interpretive steps (Schedule 1 notes refer to MoU clauses 5.1(c), 5.5, 6.9, 7.6, 7.2, 7.3).","Technical subject matter: classifications of in‑house IVDs (Class 1–4), ARTG inclusion, and technical/scientific data underpin assessment decisions (Schedule 1 items (a) and (d)).","Multiple statutory and regulatory hooks for post‑market reporting and notification obligations (references to Schedule 3, paras 6A.4(2)(c) and 6B.5(2)(c) of the MD Regulations in Schedule 1 clause 7.3) increase compliance checks.","Discretion for release rests with the Secretary under s61(5AA), requiring procedural judgement about confidentiality, public‑health justification and scope of disclosure (section 4 and Schedule 1 general note).","Operational simplicity from a single named recipient (NATA) reduces the number of potential recipient categories, lowering administrative breadth."],"plain_english_summary":"Mechanically: this Specification authorises the Secretary/TGA to disclose specified information the TGA holds about in‑house in vitro diagnostic devices (IVDs) to NATA under subsection 61(5AA) of the Therapeutic Goods Act. It lists the kinds of information (lab assessments, technology trends, performance concerns, device lists and post‑market data) that may be shared. Who it affects and why it matters: it applies to NATA, the TGA and laboratories manufacturing in‑house IVDs, enabling accreditation‑related information flows to support assessment and oversight of quality, safety and performance."},"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"The legislation remains tightly scoped to its original purpose: facilitating information sharing between TGA and NATA regarding in-house IVDs. The specification implements the Memorandum of Understanding between these bodies and does not expand beyond this specific administrative arrangement."},"complexity_factors":["Only 5 defined terms in section 3, all referencing external regulations rather than creating new definitions","Single operative provision (section 4) that simply incorporates Schedule 1 by reference","Heavy reliance on external documents — the Memorandum of Understanding between Commonwealth and NATA dated 2 September 2016 is repeatedly referenced with clause citations","Schedule 1 uses a table format with nested sub-items and multiple 'for example' illustrations that add length but not legal complexity","Cross-references to the Therapeutic Goods Act 1989 (subsections 61(5AA) and 61(5AB)) and the Medical Devices Regulations 2002 (Schedule 3, paragraphs 6A.4(2)(c) and 6B.5(2)(c))","No conditional logic, exceptions, or penalty provisions — the instrument is purely permissive/specificatory"],"plain_english_summary":"This law lets the Therapeutic Goods Administration (TGA) share confidential information about in‑house laboratory‑developed IVDs with the National Association of Testing Authorities (NATA). It covers lab accreditation, test lists, performance problems and safety concerns so the two bodies can coordinate oversight, catch faulty tests early, and protect patient safety."}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-information-sharing-information-about-in-house-in-vitro-diagnostic-medical-devices","history":"/api/acts/therapeutic-goods-information-sharing-information-about-in-house-in-vitro-diagnostic-medical-devices/history","analysis":"/api/acts/therapeutic-goods-information-sharing-information-about-in-house-in-vitro-diagnostic-medical-devices/analysis","conflicts":"/api/acts/therapeutic-goods-information-sharing-information-about-in-house-in-vitro-diagnostic-medical-devices/conflicts","importantCases":"/api/acts/therapeutic-goods-information-sharing-information-about-in-house-in-vitro-diagnostic-medical-devices/important-cases","documents":"/api/acts/therapeutic-goods-information-sharing-information-about-in-house-in-vitro-diagnostic-medical-devices/documents"}}