{"id":"F2022L01534","name":"Therapeutic Goods (Transition to EU Medical Devices Regulation) (Information) Specification 2022","slug":"therapeutic-goods-transition-to-eu-medical-devices-regulation-information-specification-2022","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":441619,"registerId":"F2022L01534-fast-fetch-1775956878167","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Transition to EU Medical Devices Regulation) (Information) Specification 2022","content":"---\nmeta-content-style-type: text/css\nmeta-content-type: application/xhtml+xml; charset=utf-8\nmeta-generator: Aspose.Words for .NET 22.10.0\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 (Transition to EU Medical Devices Regulation) (Information) Specification 2022\n\nI, Tracey Duffy, as delegate of the Minister for Health and Aged Care, make the following specification.\n\nDated 28 November 2022\n\nTracey Duffy\n\nFirst Assistant Secretary  Medical Devices and Product Quality Division  Health Products Regulation Group  Department of Health and Aged Care\n\n \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\n6  Repeals\n\nSchedule 1—Therapeutic goods information\n\nSchedule 2—Repeals\n\nTherapeutic Goods (Transition to EU Medical Devices Regulation—Stakeholder Testing) (Information) Specification 2022\n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Transition to EU Medical Devices Regulation) (Information) Specification 2022.\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instrument 5 December 2022. 5 December 2022\n\n\nNote: This table relates only to the provisions of this instrument as originally made.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 subsection 3(1) of the Act, including the following:\n\n(a) device number;\n\n(b) included in the Register;\n\n(c) kind, in relation to a medical device;\n\n(d) medical device;\n\n(e) overseas regulator conformity assessment document;\n\n(f) Secretary;\n\n(g) sponsor.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nCouncil Directive 90/385/EEC means Council Directive of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices (90/385/EEC) of the Council of the European Communities, as in force or existing at the commencement of this instrument.\n\nCouncil Directive 93/42/EEC means Council Directive 93/42/EEC of 14 June 1993 concerning medical devices of the Council of the European Communities, as in force or existing at the commencement of this instrument.\n\nEU MDD certificate means an overseas regulator conformity assessment document that is issued by a notified body under Council Directive 93/42/EEC or Council Directive 90/385/EEC.\n\nEU MDR certificate means an overseas regulator conformity assessment document that is issued by a notified body under the EU medical devices regulation.\n\nEU medical devices regulation means Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, as in force or existing at the commencement of this instrument.\n\nGMDN Agency means the not-for-profit organisation, registered in the United Kingdom, responsible for the Global Medical Device Nomenclature system.\n\nGMDN code, or Global Medical Device Nomenclature code, means the 5-digit numeric code assigned to all medical devices under the Global Medical Device Nomenclature system maintained by the GMDN Agency.\n\nGS1 means the not-for-profit standards organisation known as GS1 that has its headquarters in Belgium.\n\nGTIN, or Global Trade Item Number, means the GS1 identification key used to identify trade items.\n\nNote: A GTIN comprises a GS1 company prefix, an item reference and a check digit.\n\ninstructions for use has the same meaning as in the Medical Devices Regulations.\n\nintended purpose has the same meaning as in the Medical Devices Regulations.\n\nMedical Devices Regulations means the Therapeutic Goods (Medical Devices) Regulations 2002.\n\nnotified body means a body that has been designated by a member state of the European Union, and notified to the European Commission, to assess the conformity of medical devices, including in vitro diagnostic medical devices and active implantable medical devices.\n\nonline notification form means the online form Form: Sponsor notification for medical devices transitioning from the EU MDD to the EU MDR, which relates to the provision of information about a relevant kind of medical device and its transition, accessed via the TGA – Citizen Space website at https://consultations.tga.gov.au/tga/ef19f496/, as in force or existing at the commencement of this instrument.\n\nrelevant kind of medical device means a kind of medical device that is included in the Register and for which certification of the matter referred to in paragraph 41FD(f) of the Act is based on an EU MDD certificate.\n\nTherapeutic Goods Administration, or TGA, means that part of the Department known as the Therapeutic Goods Administration.\n\ntherapeutic goods information has the meaning given by subsection 61(1) of the Act.\n\ntransition, in relation to a relevant kind of medical device, means transition from an EU MDD certificate to an EU MDR certificate that applies to the kind of device.\n\n5  Release of therapeutic goods information\n\n  The kinds of therapeutic goods information set out in the table in Schedule 1 are specified for the purposes 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) of the Act.\n\n6  Repeals\n\n  Each instrument that is specified in Schedule 2 is repealed as set out in the applicable items in that Schedule.\n\n\n\n\nSchedule 1—Therapeutic goods information\n\nNote: See section 5.\n\n \n\n- Specified kinds of therapeutic goods information\n- Column 1 Column 2\n- Item Kinds of Information\n- 1 the following information provided by a sponsor (or a person authorised to act on behalf of a sponsor) in the online notification form in relation to the transition of a relevant kind of medical device, as applicable:(a) the manufacturer’s name;(b) the sponsor’s name;(c) contact details for enquiries;(d) the name of the kind of medical device affected by the transition;(e) the device number;(f) the GMDN code;(g) the GTIN;(h) the intended purpose;(i) the date of effect of the EU MDR certificate;(j) details of changes in relation to any of the following matters relating to the kind of medical device as a result of the transition (that is, details under the EU MDD certificate, details under the EU MDR certificate and products affected):(i) indications in the instructions for use;(ii) class of persons for which the device is suitable;(iii) intended purpose;(iv) functional description;(v) addition of a warning for a novel or newly identified safety issue or contraindication;(vi) addition of adverse event information that would change patient management recommendations\n- 2 the following dates in relation to the information mentioned in item 1:(a) the date the online notification form is submitted;(b) the date of release of that information by the TGA\n\n\n \n\n\n\n\nSchedule 2—Repeals\n\nNote: See section 6.\n\nTherapeutic Goods (Transition to EU Medical Devices Regulation—Stakeholder Testing) (Information) Specification 2022\n\n1  The whole of the instrument\n\nRepeal the instrument\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"},"kimi_summary":{"content_quality":"ok","complexity_score":3,"scope_assessment":{"changed":false,"description":"The instrument maintains its original narrow purpose: specifying what therapeutic goods information may be released to the public regarding EU medical device certificate transitions. It does not expand beyond this specific administrative transparency function."},"complexity_factors":["Short instrument with only 6 substantive sections plus 2 schedules","13 defined terms in section 4, but most are straightforward technical definitions (e.g., 'EU MDD certificate', 'GTIN')","Single operative provision (section 5) with minimal conditional logic","No nested exceptions or complex cross-referencing beyond standard references to the parent Act","Schedule 1 contains a simple table structure listing specific data fields to be released","Repeal provision (Schedule 2) is straightforward, replacing an earlier stakeholder testing instrument"],"plain_english_summary":"When a medical device sponsor tells the TGA it is switching from the old EU safety certificate (EU MDD) to the new EU MDR certificate, the TGA may publish the notification details. This affects device sponsors and gives healthcare professionals and patients public visibility into which devices are transitioning, what safety or intended‑use changes may occur, and when those changes take effect — improving transparency about device safety and use."},"flash_summary":{"complexity_score":3,"scope_assessment":{"changed":true,"description":"Yes. This specification formalises and limits the kinds of sponsor‑provided information the Secretary may publish about devices transitioning from EU MDD to EU MDR, and it repeals the earlier Stakeholder Testing (Information) Specification. The practical scope shifts from a testing/consultation phase to an operational specification of publishable fields. (s5, s6, Schedule 1, Schedule 2)"},"complexity_factors":["Authority and release rely on cross-references to the Therapeutic Goods Act 1989 (subsection 61(5D) grants power to make the specification; subsection 61(5C) governs release) — s3, s5.","Instrument depends on numerous defined terms that import EU law and other instruments (EU MDD certificate, EU MDR certificate, EU medical devices regulation, Medical Devices Regulations) — s4.","Schedule 1 prescribes detailed, technical fields for publication (manufacturer/sponsor names; device number; GMDN code; GTIN; intended purpose; certificate date; specified changes to instructions, intended users, functional description, warnings, adverse‑event information) — Schedule 1 item 1.","References an external online notification form hosted on TGA Citizen Space; the instrument ties release authority to information submitted via that form, creating an operational dependency on an external platform — s4 (online notification form).","Discretion over actual public release remains with the Secretary under the Act; the instrument specifies kinds of information that may be released but does not itself mandate publication of every instance — s5.","Administrative/operational change: the instrument repeals a prior stakeholder‑testing information specification, altering the administrative framework for this disclosure — s6, Schedule 2.","Low legislative drafting complexity (short, focused instrument) but higher technical specificity because of multiple device identifiers and cross‑instrument references, which requires coordination between sponsors, manufacturers and the TGA — s4, Schedule 1."],"plain_english_summary":"This instrument authorises the TGA Secretary to publish specified information that sponsors provide via an online notification when a medical device transitions from an EU MDD certificate to an EU MDR certificate. It lists manufacturer and sponsor names, device identifiers (device number, GMDN code, GTIN), the EU MDR certificate date, and certain changes to intended purpose, instructions, warnings or adverse‑event information.\n\nIt affects sponsors, manufacturers and the TGA: sponsors supply the data, the Secretary decides release, and sponsors must complete the online form, creating a modest administrative compliance requirement. (s3, s5, Schedule 1)"}},"importantCases":[],"_links":{"self":"/api/acts/therapeutic-goods-transition-to-eu-medical-devices-regulation-information-specification-2022","history":"/api/acts/therapeutic-goods-transition-to-eu-medical-devices-regulation-information-specification-2022/history","analysis":"/api/acts/therapeutic-goods-transition-to-eu-medical-devices-regulation-information-specification-2022/analysis","conflicts":"/api/acts/therapeutic-goods-transition-to-eu-medical-devices-regulation-information-specification-2022/conflicts","importantCases":"/api/acts/therapeutic-goods-transition-to-eu-medical-devices-regulation-information-specification-2022/important-cases","documents":"/api/acts/therapeutic-goods-transition-to-eu-medical-devices-regulation-information-specification-2022/documents"}}