{"id":"F2019L00426","name":"Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019","slug":"therapeutic-goods-conformity-assessment-standard-for-quality-management-systems-order-2019","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":440003,"registerId":"F2019L00426-fast-fetch-1775955807146","compilationNumber":null,"startDate":"2026-04-12","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 2019","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 (Conformity Assessment Standard for Quality Management Systems) Order 2019\n\nI, Miranda Lauman, as delegate of the Minister for Health, make the following order.\n\nDated 26 March 2019\n\nMiranda Lauman\n\nAssistant Secretary\n\nMedical Devices Branch\n\nHealth Products Regulation Group\n\nDepartment of Health\n\n \n\nContents\n\n1  Name\n\n2  Commencement\n\n3  Authority\n\n4  Definitions\n\n5  Conformity assessment standardsquality management systems\n\n6  Conformity assessment standardsquality management systems for kinds of medical devices intended to be supplied in a sterile state\n\n7  Repeals\n\nSchedule 1—Conformity assessment standards\n\nSchedule 2—Conformity assessment standards for medical devices intended to be supplied in a sterile state\n\nSchedule 3—Repeals\n\nConformity Assessment Standards Order (Standard for Quality Management Systems and Quality Assurance Techniques) 2008\n\n \n\n1  Name\n\n  This instrument is the Therapeutic Goods (Conformity Assessment Standard for Quality Management Systems) Order 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 31 March 2019. 31 March 2019\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 section 41DC 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) conformity assessment procedures;\n\n(b) kind, in relation to a medical device;\n\n(c) manufacturer, of a medical device; and\n\n(d) medical device.\n\n  In this instrument:\n\nAct means the Therapeutic Goods Act 1989.\n\nISO means the International Organisation for Standardization.\n\nRegulations means the Therapeutic Goods (Medical Devices) Regulations 2002.\n\nstandard means a standard published by the ISO, as in force or existing immediately before the commencement of this instrument.\n\nNote: Standards are published by the ISO at https//www.iso.org.\n\n5  Conformity assessment standardsquality management systems\n\n (1) This section applies in relation to the manufacture of a kind of medical device, whether or not it is intended by the manufacturer to be supplied in a sterile state.\n\n (2) The matters specified in a standard, or part of a standard, mentioned in column 2 of an item in the table in Schedule 1 to this instrument constitute a conformity assessment standard for a quality management system mentioned in Part 1, 4 or 5 of Schedule 3 to the Regulations.\n\n (3) A quality management system mentioned in Part 1, 4 or 5 of Schedule 3 to the Regulations that complies with a standard, or part of a standard, mentioned in column 2 of an item in the table in Schedule 1 to this instrument is to be treated as having had applied to it those parts of the conformity assessment procedures specified in column 3 of that item.\n\n6  Conformity assessment standardsquality management systems for kinds of medical devices intended to be supplied in a sterile state\n\n (1) This section applies in relation to the manufacture of a kind of medical device that is intended by the manufacturer to be supplied in a sterile state.\n\n (2) The matters specified in a standard, or part of a standard, mentioned in column 2 of an item in the table in Schedule 2 to this instrument, when used for a purpose mentioned in column 3 of that item, constitute a conformity assessment standard for a quality management system mentioned in Part 1 or 4 of Schedule 3 to the Regulations.\n\n (3) A quality management system mentioned in Part 1 or 4 of Schedule 3 to the Regulations that complies with a standard, or part of a standard, mentioned in column 2 of an item in the table in Schedule 2 to this instrument, when that standard is used for the purpose mentioned in column 3 of that item, is to be treated as having had applied to it those parts of the conformity assessment procedures specified in column 4 of that item.\n\n7  Repeals\n\n  Each instrument that is specified in Schedule 3 to this instrument is repealed as set out in the applicable items in that Schedule.\n\n\n\n\nSchedule 1—Conformity assessment standards\n\nNote: See section 5.\n\n \n\n- Conformity assessment standards for quality management systems\n- Column 1 Column 2 Column 3\n- Item Standard Conformity assessment procedures\n- 1 ISO 13485:2016 Medical devicesQuality management systemsRequirements for regulatory purposes the conformity assessment procedures set out in clause 1.4 of Part 1 of Schedule 3 to the Regulations\n- 2 ISO 13485:2016 Medical devicesQuality management systemsRequirements for regulatory purposes, other than clause 7.3 Design and Development the conformity assessment procedures set out in clause 4.4 of Part 4 of Schedule 3 to the Regulations\n- 3 ISO 13485:2016 Medical devicesQuality management systemsRequirements for regulatory purposes, other than:(a) clause 7.3 Design and Development; and(b) clause 7.5.6 Validation of processes for production and services provision the conformity assessment procedures set out in clause 5.4 of Part 5 of Schedule 3 to the Regulations\n\n\n\n\n\nSchedule 2—Conformity assessment standards for medical devices intended to be supplied in a sterile state\n\nNote: See section 6.\n\n \n\n- Conformity assessment standards for quality management systems for kinds of medical devices intended by their manufacturer to be supplied in a sterile state\n- Column 1 Column 2 Column 3 Column 4\n- Item Standard Purpose Conformity assessment procedures\n- 1 both of the following:(a) ISO 11135:2014 Sterilization of health-care productsEthylene oxideRequirements for the development, validation and routine control of a sterilization process for medical devices; and(b) ISO 11135:2014/Amd 1:2018 Revision of Annex E, Single batch release for use in the validation and routine control of ethylene oxide sterilization processes for medical devices (a) the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and(b) the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations\n- 2 all of the following:(a) ISO 11137-1:2006 Sterilization of health care productsRadiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; and(b) ISO 11137-1:2006/Amd 1:2013; and(c) ISO 11137-1:2006/Amd 2:2018 Revision to 4.3.4 and 11.2; and(d) ISO 11137-2:2013 Sterilization of health care productsRadiationPart 2: Establishing the sterilization dose; and(e) ISO 11137-3:2017 Sterilization of health care productsRadiationPart 3: Guidance on dosimetric aspects of development, validation and routine control; and(f) ISO/TS 13004:2013 Sterilization of health care productsRadiation Substantiation of selected sterilization dose: Method VDmaxSD for use in the validation and routine control of radiation sterilization processes for medical devices (a) the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and(b) the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations\n- 3 all of the following:(a) ISO 13408-1:2008 Aseptic processing of health care productsPart 1: General requirements; and(b) ISO 13408-1:2008/ Amd 1:2013; and(c) ISO 13408-2:2018 Aseptic processing of health care productsPart 2: Sterilizing filtration; and(d) ISO 13408-3:2006 Aseptic processing of health care productsPart 3: Lyophilization; and(e) ISO 13408-4:2005 Aseptic processing of health care productsPart 4: Clean-in-place technologies; and(f) ISO 13408-5:2006 Aseptic processing of health care productsPart 5: Sterilization in place; and(g) ISO 13408-6:2005 Aseptic processing of health care productsPart 6: Isolator systems; and(h) ISO 13408-6:2005/Amd 1:2013; and(i) ISO 13408-7:2012 Aseptic processing of health care productsPart 7: Alternative processes for medical devices and combination products for use in the validation and routine control of aseptic manufacturing processes for medical devices that are not terminally sterilized, including sterilizing filtration, lyophilisation, clean-in-place technologies, sterilization in place, isolator systems and alternative processes for medical devices and combination products (a) the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and(b) the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations\n- 4 ISO 14160:2011 Sterilization of health care productsLiquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivativesRequirements for characterization, development, validation and routine control of a sterilization process for medical devices for use in the validation and routine control of sterilization processes for medical devices using liquid chemical sterilants (a) the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and(b) the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations\n- 5 ISO 14937:2009 Sterilization of health care productsGeneral requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices for use in the validation and routine control of a sterilization process for medical devices that is not mentioned in any of the standards specified in items 1 to 4 (a) the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and(b) the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations\n- 6 ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices for use in circumstances where the manufacturer reasonably considers that a medical device is suitable to be cleaned and re-sterilized (a) the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and(b) the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations\n- 7 ISO 17665-1:2006 Sterilization of health care productsMoist heatPart 1: Requirements for the development, validation and routine control of a sterilization process for medical devices for use in the validation and routine control of steam sterilization processes (a) the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and(b) the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations\n- 8 ISO 18362:2016 Manufacture of cell-based health care productsControl of microbial risks during processing for use in the validation and routine control of manufacturing processes used for cell-based health care products that are medical devices (a) the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and(b) the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations\n- 9 ISO 20857:2010 Sterilization of health care productsDry heatRequirements for the development, validation and routine control of a sterilization process for medical devices for use in the validation and routine control of dry heat sterilization processes (a) the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and(b) the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations\n- 10 ISO 25424:2018 Sterilization of health care productsLow temperature steam and formaldehydeRequirements for development, validation and routine control of a sterilization process for medical devices for use in the validation and routine control of low temperature steam and formaldehyde sterilization processes (a) the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and(b) the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations\n- 11 both of the following:(a) ISO 11607-1:2019 Packaging for terminally sterilized medical devicesPart 1: Requirements for materials, sterile barrier systems and packaging systems; and(b) ISO 11607-2:2019 Packaging for terminally sterilized medical devicesPart 2: Validation requirements for forming, sealing and assembly processes for use in the validation and routine control of terminally sterilized medical devices (a) the conformity assessment procedures set out in subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations; and(b) the conformity assessment procedures set out in subparagraph 4.4(5)(c)(i) of Part 4 of Schedule 3 to the Regulations\n\n\nSchedule 3—Repeals\n\nConformity Assessment Standards Order (Standard for Quality Management Systems and Quality Assurance Techniques) 2008\n\n1  The whole of the instrument\n\nRepeal the instrument.\n\n \n","sortOrder":0}],"analysis":{"kimi_summary":{"content_quality":"ok","complexity_score":4,"scope_assessment":{"changed":false,"description":"The instrument maintains the same scope as its predecessor (the 2008 Order it repeals). It continues to specify conformity assessment standards for quality management systems in medical device manufacturing. The updates are modernizing rather than expanding — replacing outdated ISO standard references with current versions (notably ISO 13485:2006 → ISO 13485:2016) and adding newer sterilization standards for emerging technologies like cell-based products. The core purpose remains unchanged: providing a streamlined pathway for manufacturers to demonstrate compliance through recognized international standards."},"complexity_factors":["Extensive cross-referencing to external documents: the instrument relies heavily on incorporated ISO standards (ISO 13485:2016, ISO 11135:2014, ISO 11137 series, ISO 13408 series, etc.) that are not reproduced in the text","Nested conditional logic in Schedule 1: three tiers of compliance based on which clauses of ISO 13485 are excluded (full standard, minus clause 7.3, or minus clauses 7.3 and 7.5.6)","Dual-track structure: separate schedules for general quality management versus sterile devices, with different regulatory consequences","Precise subparagraph references to the Therapeutic Goods (Medical Devices) Regulations 2002 (e.g., \"subparagraph 1.4(5)(d)(i) of Part 1 of Schedule 3 to the Regulations\")","Multiple amendment documents bundled together for sterile device standards (e.g., Item 2 of Schedule 2 requires compliance with ISO 11137-1:2006 plus two separate amendments)","Technical terminology requiring domain expertise: \"lyophilization,\" \"dosimetric aspects,\" \"VDmaxSD method,\" \"clean-in-place technologies\""],"plain_english_summary":"This Order lets medical device manufacturers (including those making sterile products) rely on recognised international quality-management standards—notably ISO 13485:2016—to show their manufacturing meets Australian safety requirements, and it guides the TGA’s acceptance of that evidence.\n\nBy referencing global standards it cuts red tape for certified producers, keeps Australian rules aligned with international best practice, and updates an older 2008 Order to current standards."},"flash_summary":{"complexity_score":6,"scope_assessment":{"changed":false,"description":"This instrument replaces and updates the Conformity Assessment Standards Order 2008 (Schedule 3) by listing newer ISO standards and specifying which parts of those standards map to particular conformity-assessment procedures in the Regulations (s5–6, Schedules 1–2). The instrument does not broaden the regulatory purpose beyond setting conformity-assessment standards for QMS; rather, it modernises and clarifies which international standards (and which clauses) are treated as satisfying parts of the existing conformity-assessment framework. The core scope—identifying acceptable QMS standards for conformity assessment—remains the same as the original instrument, although the technical coverage and specificity have been updated to current ISO editions and to include detailed sterile-device standards."},"complexity_factors":["Multiple external technical standards listed (Schedule 1 has 3 items; Schedule 2 has 11 items with multiple sub-documents in several items).","Cross-references to the Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 3 (Parts 1, 4 and 5) and to specific subparagraphs (e.g. 1.4(5)(d)(i), 4.4(5)(c)(i)), creating layered legal-technical mapping.","Conditional exclusions and partial-adoption language (e.g. ISO 13485:2016 “other than clause 7.3” and other clause exclusions in Schedule 1 items 2–3).","Definition of “standard” as the ISO publication “in force or existing immediately before the commencement” (a frozen temporal reference that affects future applicability).","Technical subject-matter complexity (sterilisation, aseptic processing, packaging, radiation, ethylene oxide) requiring domain expertise to interpret compliance implications.","Repeal of a prior instrument (2008 Order) and replacement logic (Schedule 3), requiring comparison to prior regulatory instruments for full historical scope analysis.","Multiple mappings (different standards map to different conformity-assessment procedures), increasing the combinatorial possibilities manufacturers must check.","Short instrument text but heavy reliance on external documents (ISO standards and the Regulations), so understanding full effect requires reading multiple external sources."],"plain_english_summary":"**What this instrument does (mechanically)**\n\n- Updates the list of international ISO standards that the Australian regulator treats as acceptable \"conformity assessment standards\" for medical-device quality management systems (QMS). (See section 5, Schedule 1 and section 6, Schedule 2.)\n- Maps specific ISO standards (or parts of them) to specified conformity assessment procedures set out in the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations). If a manufacturer’s QMS complies with a named ISO standard (or the specified part), the QMS is to be treated as having had the corresponding conformity assessment procedure applied. (See sections 5(2)–(3) and 6(2)–(3).)\n- Provides a specialised list of ISO standards that apply when a manufacturer intends a device to be supplied sterile, and links those standards to particular conformity assessment pathways in the Regulations. (See Schedule 2 and section 6.)\n- Repeals the earlier Conformity Assessment Standards Order from 2008. (See section 7 and Schedule 3.)\n\n**Who this affects**\n\n- Medical device manufacturers (including overseas manufacturers) whose devices are subject to Australian conformity assessment for market supply. They must ensure their QMS meets the specified ISO standards if they want to rely on the mapped conformity-assessment procedures (s5–6). \n- Conformity assessment bodies and auditors who assess QMS against the Regulations—because the instrument determines which ISO standards count for particular assessment routes. \n- Sponsors, importers and downstream entities indirectly, because the instrument affects the pathway by which devices obtain regulatory clearance.\n\n**Why it matters (official purpose and practical effect)**\n\n- The instrument’s stated practical effect is to recognise current ISO standards as acceptable means of meeting Australia’s conformity assessment requirements for QMS, including specialised sterilisation and aseptic-processing standards for sterile-supply devices (Schedules 1–2). The practical mechanism is equivalence: compliance with the named ISO standard is treated as equivalent to having certain parts of the prescribed conformity assessment procedures applied (s5(3), s6(3)).\n\n**Costs, incentives, trade-offs and implementation mechanics**\n\n- Compliance burden: Manufacturers who want to rely on the mapped conformity-assessment procedures must implement and maintain the specified ISO standards. That typically means internal costs for updating QMS, additional audits, and documentation. The instrument narrows exactly which clauses or parts of ISO 13485:2016 are accepted for particular assessment routes (Schedule 1 items 1–3), which can increase or reduce implementation work depending on whether clauses are accepted or expressly excluded (see Schedule 1 items 2–3 excluding clause 7.3 and clause 7.5.6 in parts).\n\n- Regulatory certainty vs. lag risk: The instrument ties Australia’s acceptance to specific ISO versions as they existed immediately before commencement (the instrument’s definition of “standard”). That provides certainty about which ISO texts count today but can create delay before more recent ISO updates are accepted, unless the instrument is amended (Definitions, section 4). This is an implementation risk for manufacturers tracking international standard updates.\n\n- Specialisation for sterile devices: For devices intended to be supplied sterile, the order lists multiple sterilisation and aseptic-processing ISO standards (Schedule 2). That channels manufacturers into technically specific assessment routes and may increase the technical documentation and validation work manufacturers must supply (s6 and Schedule 2).\n\n- Effect on market players: By recognising ISO standards as conformity-assessment standards, the instrument reduces the need for Australia-specific QMS rules where those ISO standards cover material requirements. That supports international harmonisation for firms already certified to those ISO standards. At the same time, the instrument preserves the regulator’s ability to require additional documentation or link compliance to particular parts of the conformity-assessment procedures in the Regulations (s5(3), s6(3)).\n\n- Who pays and who decides: Manufacturers pay the compliance and auditing costs. The regulator (the Minister’s delegate under section 41DC of the Therapeutic Goods Act 1989) decides which ISO standards are recognised by making or amending orders like this one (see section 3 on authority and the operative sections 5–6). Conformity-assessment bodies carry out the audits under the mapped procedures.\n\n**Concrete behavioural changes**\n\n- Manufacturers seeking conformity assessment under the specified parts of the Regulations can do so by meeting the listed ISO standards (s5–6, Schedules 1–2). \n- Manufacturers of sterile devices will direct resources to the listed sterilization and aseptic-processing standards in Schedule 2 to be eligible for the mapped conformity-assessment outcomes (s6).\n\n**Implementation issues, discretion and trade-offs**\n\n- The instrument is technical and prescriptive: it fixes particular ISO documents (specific editions and, in some items, specific clauses) to particular assessment routes. This reduces ambiguity but requires periodic statutory updating to reflect new ISO revisions.\n- The regulator retains discretion by choosing which ISO versions and which parts of those standards count. That discretion concentrates decision-making in the Department (section 3 authority), and operationally requires updates to the instrument when international standards evolve.\n- The mapping to specific subparagraphs of the Regulations (for example, subparagraph 1.4(5)(d)(i) of Part 1, subparagraph 4.4(5)(c)(i) of Part 4, etc.) creates technical cross-references that users must follow precisely. Failing to match the right standard to the right procedure may change the route of assessment required.\n\n**Key references in the instrument**\n\n- General QMS mapping: section 5 and Schedule 1.\n- Sterile-supply QMS mapping: section 6 and Schedule 2.\n- Definition of which ISO text counts (frozen to versions in force immediately before commencement): section 4 (definition of “standard”).\n- Repeal of earlier order: section 7 and Schedule 3.\n\n"},"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-conformity-assessment-standard-for-quality-management-systems-order-2019","history":"/api/acts/therapeutic-goods-conformity-assessment-standard-for-quality-management-systems-order-2019/history","analysis":"/api/acts/therapeutic-goods-conformity-assessment-standard-for-quality-management-systems-order-2019/analysis","conflicts":"/api/acts/therapeutic-goods-conformity-assessment-standard-for-quality-management-systems-order-2019/conflicts","importantCases":"/api/acts/therapeutic-goods-conformity-assessment-standard-for-quality-management-systems-order-2019/important-cases","documents":"/api/acts/therapeutic-goods-conformity-assessment-standard-for-quality-management-systems-order-2019/documents"}}