Therapeutic Goods (Transition to EU Medical Devices Regulation) (Information) Specification 2022

The instrument rests on three principal statutory and technical concepts.

1. Therapeutic goods information and the Secretary’s release power. The instrument operates under subsection 61(5D) of the Therapeutic Goods Act 1989 and specifies kinds of "therapeutic goods information" for the purposes of subsection 61(5C) (section 3 and section 5). The instrument therefore interacts directly with the Act’s existing disclosure power: once a kind of information is specified under subsection 61(5D), it may be released to the public under subsection 61(5C). The instrument itself does not exercise the release power; it simply enumerates the kinds of information that may be released.

2. The transition from EU MDD to EU MDR as a trigger. The scope of the specified information is tied to the transition of a "relevant kind of medical device" from certification based on the EU medical devices directives (Council Directive 93/42/EEC and 90/385/EEC, collectively referenced in the definitions) to certification under the EU medical devices regulation (Regulation (EU) 2017/745) (section 4 definitions and Schedule 1). The instrument therefore creates a disclosure cohort defined by regulatory history: kinds of device that are included in the Register and for which the certification matter referred to in paragraph 41FD(f) of the Act is based on an EU MDD certificate (definition of relevant kind of medical device).

3. Sponsor-provided data via a specified online notification form. The information the instrument specifies for release is explicitly the information "provided by a sponsor (or a person authorised to act on behalf of a sponsor) in the online notification form" that concerns transition (Schedule 1, item 1). The instrument identifies the particular online form by name and by its TGA Citizen Space URL in the definitions (section 4). The instrument further specifies the precise data fields that will be in scope for release: manufacturer name; sponsor name; contact details for enquiries; device name; device number; GMDN code; GTIN; intended purpose; date of effect of the EU MDR certificate; and detailed descriptions of changes between EU MDD and EU MDR in prescribed categories (Schedule 1, item 1(a)-(j) and (i)(i)-(vi)). It also lists two date fields in item 2 (submission date and TGA release date).

Other technical concepts in the instrument include the following definitional cross-references: GMDN Agency and GMDN code (the instrument names the UK-based not-for-profit that maintains the Global Medical Device Nomenclature), GS1 and GTIN, notified body, and the Medical Devices Regulations for definitions of "instructions for use" and "intended purpose" (section 4). These definitions constrain how some of the specified fields should be interpreted when the Secretary releases information.

Finally, the instrument removes the earlier "Stakeholder Testing" information specification instrument by repeal (section 6 and Schedule 2). That repeal mechanism mechanically replaces the prior specification with this one in respect of the kinds of information identified.

Primary affected parties

• Sponsors of medical devices: The Schedule expressly treats the specified information as information "provided by a sponsor (or a person authorised to act on behalf of a sponsor) in the online notification form" (Schedule 1, item 1). Sponsors are therefore the source of the data elements the Secretary may release. The instrument therefore affects sponsors’ choices about whether and how to populate the online notification form fields, knowing that those fields are listed for potential public release.

• The Therapeutic Goods Administration and the Secretary: The instrument gives the Secretary the specific content categories that may be released under the Act (section 5 and Schedule 1). The TGA will be the operational publisher; the instrument refers to the online notification form accessible via the TGA Citizen Space site (section 4, online notification form definition). The Secretary/TGA must therefore manage receipt, recordkeeping, and eventual release of the specified fields and the two dates in Schedule 1, item 2.

• Manufacturers and notified bodies: Manufacturer names and certification dates are included among the fields listed for release (Schedule 1, item 1(a), item 1(i)). Notified bodies are implicated as originators of EU MDD and EU MDR certificates (definitions in section 4). Manufacturers who are not sponsors will nonetheless be named in released data if their name appears in sponsors’ form submissions.

Secondary affected parties

• Healthcare providers, patients and the public: The instrument makes data elements available for public release (section 5 and Schedule 1), so clinicians, procurement officers, hospitals and patients will have access to the specified identifiers and descriptive changes where the Secretary elects to publish them. The public interest stakeholder base that may use the disclosed data is therefore affected in terms of access to manufacturer, sponsor and device transition information.

• Third-party data users and standards bodies: The instrument lists international nomenclature and identifier systems (GMDN code, GTIN) as fields (section 4 and Schedule 1). Entities that index device data, run device registries, or otherwise process device identifiers will be able to use the released identifiers. The instrument names the GMDN Agency and GS1 in the definitions, anchoring the identifier concepts to their respective organisations (section 4).

Matters not altered by the instrument

• No new regulatory classification rules are introduced: The instrument does not change medical device classes, clinical evidence requirements, or certification standards. It is limited to specifying the kinds of information that may be released under the Act (section 5).

• No new penalties or civil obligations on sponsors are created in the instrument itself. The instrument does not expressly create an obligation to submit the online notification form, nor does it create sanctions for non-compliance; rather, it specifies what data will be releasable if supplied (see section 5 and Schedule 1). Any obligations to notify or to update registers would arise elsewhere in the Act or subsidiary instruments; those are not altered by this specification.

Who decides

• The Secretary of the Department of Health and Aged Care holds the release discretion under the Act; the instrument supplies the content categories that the Secretary may release (section 5).

Who pays and who bears costs

• Sponsors will bear the direct administrative cost of supplying the information in the online notification form, including identifying the device by GMDN code and GTIN and detailing changes produced by transition (Schedule 1). The instrument does not allocate fees or other monetary charges; it imposes an informational disclosure consequence tied to the sponsor’s supply of data.

The instrument specifies informational content for release; it does not itself impose a broad new compliance regime. The duties and rights that follow from the instrument are limited and flow from the instrument’s text combined with the Act’s disclosure framework.

Duties (as specified or implicated)

• Duty to the Secretary to supply information via a specified channel, if acting in the stakeholder process. The instrument ties the releasable information to entries "provided by a sponsor (or a person authorised to act on behalf of a sponsor) in the online notification form" (Schedule 1, item 1). While the instrument does not create a statutory obligation to submit the form, sponsors who provide information in that form for transition-related purposes should act on the understanding that the listed fields are specified for release.

• Duty of accurate identification of device identifiers and nomenclature. The specified releasable items include technical identifiers and descriptors: device number, GMDN code, GTIN, and intended purpose (Schedule 1, item 1(e)-(h)). If a sponsor supplies those fields in the online form, the Secretary may release them. That creates a de facto duty on sponsors to ensure accuracy where they choose to submit those elements.

Rights

• Secretary’s discretion to release. Under subsection 61(5C) of the Act, the Secretary is empowered to release therapeutic goods information. This instrument narrows what that therapeutic goods information may comprise in respect of EU MDD→EU MDR transitions by listing the specific kinds of information (section 5). The Secretary retains the constitutional and statutory discretion to decide whether and when to release specified information; the instrument specifies content, not timing or format of release.

• Sponsor control over whether to provide data to the specified online form. Because the instrument only specifies for release the information that is supplied in the named online notification form, sponsors retain the practical choice of whether to populate that form. The instrument does not itself compel submission.

Points of interpretation and cross-reference

• “Relevant kind of medical device” definition ties disclosure to a particular certification history: the kind must be included in the Register and its certification under the Act’s paragraph 41FD(f) must be based on an EU MDD certificate (section 4 definition). That linkage indicates that the instrument’s release scope is limited to kinds of device with that historical certification basis.

• Certain terms used in the specified fields are defined by secondary instruments (for example, "instructions for use" and "intended purpose" have the same meaning as in the Medical Devices Regulations) and several expressions are already defined by subsection 3(1) of the Act (section 4). Sponsors and the Secretary will treat those cross-referenced definitions as authoritative for understanding the fields that may be released.

Operational duties for the TGA

• Receipt and recording of online notification entries that identify the specified fields and the two dates listed for publication (Schedule 1, item 2). The Secretary/TGA will operationally manage the receipt of data and any publication process, because the instrument specifies the content but does not prescribe the publication mechanism other than the reference to the online form and the fact of release power under the Act (section 5).

Limitations on duties and rights

• The instrument does not purport to compel sponsors to supply the fields, nor does it create enforcement penalties for failing to supply or for supplying inaccurate information. Any obligations, compliance mechanisms or sanctions would need to be found in the Act or other instruments; this specification limits itself to content definition for release power purposes.

The instrument does not create any criminal offences, civil penalties, or administrative fines. It is an information-specification instrument made under subsection 61(5D) of the Therapeutic Goods Act 1989 and, in its express terms, confines itself to defining kinds of therapeutic goods information that may be released under subsection 61(5C) of the Act (section 5). No clause in the text imposes penalties or enforcement measures.

Enforcement of the instrument’s effect is therefore indirect and procedural rather than punitive:

• Enforcement of disclosure: The Secretary’s power under the Act to release therapeutic goods information is exercised under the Act’s statutory regime; the specification determines the kinds of information in respect of which release may be made. Any enforcement or challenge to a decision to release or not release information would arise under the Act’s administrative law framework and general judicial review principles rather than by reference to penalties in this instrument. The instrument itself contains no mechanism for penalising sponsors for providing particular content.

• Accuracy and misleading information: The instrument requires no statutory certification or sworn statement from a sponsor when completing the online notification form; the instrument does not create a statutory offence for inaccurate or false entries. If inaccurate information is provided, the instrument does not set out remedial sanctions; remedies (if any) would need to be found in other provisions of the Act or elsewhere.

• Repeal as enforcement transition: The instrument repeals the prior "Stakeholder Testing" (Information) Specification 2022 in full (section 6 and Schedule 2). That repeal replaces one specification with this specification; it is an administrative housekeeping step rather than an enforcement action against particular parties.

Practical consequences

• Sponsors who supply the online notification form must anticipate public disclosure of the specified fields (Schedule 1). That disclosure risk is the instrument’s principal operational consequence because it may have reputational, commercial or procurement effects for sponsors and manufacturers, even though the instrument imposes no monetary penalties.

• The Secretary/TGA will be the decision-maker as to whether information is released under the Act in accordance with the specification. Administrative review or judicial review of release decisions would proceed under general administrative law principles rather than under any enforcement provisions in the instrument itself.

Express statutory interaction

• The instrument is made under subsection 61(5D) of the Therapeutic Goods Act 1989 and operates to specify kinds of "therapeutic goods information" for the purposes of subsection 61(5C) of the Act (section 3 and section 5). It therefore depends on the substantive and procedural framework in Part 9 of the Act that governs therapeutic goods information and the Secretary’s disclosure powers. The instrument does not amend the Act; it functions within the Act’s existing statutory architecture.

Cross-references to the Medical Devices Regulations and other definitions

• The instrument imports the meaning of "instructions for use" and "intended purpose" from the Therapeutic Goods (Medical Devices) Regulations 2002 (section 4). That link means the instrument’s specified fields must be read consistently with the Medical Devices Regulations’ definitions. Consequently, when "intended purpose" is listed in Schedule 1 (item 1(h)), its meaning is the one provided by the Medical Devices Regulations.

• The instrument also relies on other Act definitions enumerated in subsection 3(1) of the Act (for example device number, sponsor, medical device). The instrument explicitly notes that a number of expressions used in the instrument are defined in subsection 3(1) of the Act (section 4 note). That means the instrument’s terms are not free-standing but imported into the Act’s broader definitional framework.

International standards and identifiers

• The instrument incorporates references to international nomenclature and identification systems,GMDN code (Global Medical Device Nomenclature) and GTIN (Global Trade Item Number) and cites the GMDN Agency and GS1 organisations in the definitions (section 4). The instrument does not change the operation or legal status of those international systems; it merely specifies that those identifiers are among the data items that may be released.

Interaction with prior instruments

• The instrument expressly repeals the Therapeutic Goods (Transition to EU Medical Devices Regulation,Stakeholder Testing) (Information) Specification 2022 in full (section 6 and Schedule 2). That repeal means the specified kinds of therapeutic goods information listed in the earlier stakeholder-testing instrument are now replaced by the list in this instrument. The effect is administrative continuity with content update rather than a change of legal principle.

Matters the instrument does not address (and therefore requires cross-reference)

• Obligations to notify, to maintain Register entries, or to update certification information are not created or varied by this instrument. Any regulatory duties on sponsors or manufacturers in relation to certification or Register inclusion remain governed by the Act and subsidiary legislation (those obligations are not altered by this instrument).

• Privacy, confidentiality and commercial-in-confidence protections are not expressly addressed in the instrument. The instrument specifies what may be released under the Act’s disclosure power; any interactions with privacy laws or claims of commercial confidentiality would need to be resolved under those regimes or by application of the Act’s disclosure and exemption provisions (the instrument itself does not set out those exemption procedures).

Administrative law and review

• Decisions by the Secretary to release or not release therapeutic goods information are administrative decisions under the Act. The instrument provides the content categories but does not remove the Secretary’s decision-making functions. Administrative review rights applicable to Secretary decisions under the Act and general administrative law remain the pathway for challenging release decisions; nothing in the instrument modifies those channels.

This instrument is short and contains a limited set of amendment-related facts:

• Date and maker: The instrument was made on 28 November 2022 by Tracey Duffy as delegate of the Minister for Health and Aged Care (front page), and its commencement is 5 December 2022 (section 2).

• Authority: The instrument is made under subsection 61(5D) of the Therapeutic Goods Act 1989 (section 3).

• Repeal of prior instrument: The instrument expressly repeals the prior Therapeutic Goods (Transition to EU Medical Devices Regulation,Stakeholder Testing) (Information) Specification 2022 in full (section 6 and Schedule 2). Schedule 2 states: "The whole of the instrument , Repeal the instrument."

• Commencement table: Section 2 contains a commencement table which shows the whole instrument commenced on 5 December 2022. The instrument includes the usual note that the table relates only to the instrument as originally made and will not be amended for later amendments.

No further amendments, modifications, or subsequent instruments are contained in the text provided. There is no in-text amendment history beyond the single repeal of the named stakeholder-testing instrument and the initial making and commencement dates. The instrument does not itself provide for staged commencement of different provisions: the whole instrument commenced on the single date specified (section 2).

Because the instrument is an exercise of the specification power in subsection 61(5D) of the Act, any future changes to what kinds of information may be released would require a further specification instrument under the same subsection. The instrument does not itself create delegated or rule-making powers beyond this specification; it can therefore be amended or repealed in the ordinary way for legislative instruments.

The instrument contains no reported litigation, case citations, or references to judicial determinations. The text does not mention any court or tribunal decisions, and no litigation history is recorded within the instrument. Where stakeholders might seek to challenge a Secretary decision to publish or not publish specified therapeutic goods information, those challenges would arise under the Therapeutic Goods Act 1989 and general administrative law, but no specific cases or decisions are referenced in this instrument.

The instrument itself is administrative in character: it specifies content categories for disclosure under the Act rather than creating a contested statutory duty that would, on its face, generate litigation. Any litigation that might arise in practice would be procedural (for example, challenges to particular release decisions, claims of confidentiality, or disputes about whether a particular kind of device is a "relevant kind of medical device" within the instrument’s definition). The instrument does not identify dispute resolution mechanisms or precedent.

In summary, the instrument contains no litigation history and does not cite any cases. Any legal proceedings related to the use or application of this specification would have to be traced in external sources or case law, which are not part of the instrument itself.

This instrument is narrowly framed and several practical pitfalls flow directly from its narrow framing and the express wording. The following items identify specific points to watch, each grounded in the instrument’s text.

1. Release is limited to what the sponsor provides in the specified online form. Schedule 1 itemises the fields that are to be specified kinds of therapeutic goods information (Schedule 1, item 1). The Schedule’s wording is precise: it is "the following information provided by a sponsor (or a person authorised to act on behalf of a sponsor) in the online notification form". If a sponsor puts additional material in a different channel, that material is not specified by this instrument. Conversely, anything placed in the online form in the listed fields is within the specified kinds of information and therefore may be released.

2. The online form is specified by name and by URL as it existed "as in force or existing at the commencement of this instrument" (section 4 definition of online notification form). The instrument therefore anchors the disclosure specification to the form version available at commencement. If the TGA updates or replaces the online form after commencement, questions may arise about whether new fields are covered by the specification; the instrument’s wording ties the specification to the online form "as in force or existing at the commencement", so sponsors should assume the named form-version fields are in scope and should check whether subsequent specifications are made if the form changes.

3. The instrument’s scope is limited to "relevant kind of medical device" as defined. That definition requires the kind to be included in the Register and the certification of the matter referred to in paragraph 41FD(f) of the Act to be based on an EU MDD certificate (section 4). Sponsors should not assume all devices are in scope; the instrument ties disclosure to a specific certification history. Determining whether a device kind is a "relevant kind of medical device" will therefore require cross-reference to the Register and to the certification basis recorded under the Act.

4. The instrument names technical identifiers that require correct coding. The specified items include GMDN code and GTIN (Schedule 1, item 1(f)-(g); section 4 definitions). These identifiers are precise and governed by external nomenclature rules. Errors in coding or in choosing a GMDN code may result in incorrect public records. Sponsors need to ensure they use the correct GMDN and GTIN entries.

5. The instrument does not provide confidentiality carve-outs or process for redaction. The Schedule lists contact details for enquiries among releasable fields (Schedule 1, item 1(c)). The instrument does not itself include a process for redaction of commercially sensitive information. If sponsors desire to protect certain material, that protection will need to be sought under other statutory provisions (for example the Act’s general disclosure exemptions) or by avoiding supplying the material in the specified online form fields. The instrument itself creates the presumption that listed fields are specified kinds of information for potential release.

6. The instrument discloses both the submission date and the TGA release date (Schedule 1, item 2). Those metadata fields will create a public trail showing when sponsors supplied information versus when the Secretary published it. That timing information may be relevant to procurement, market surveillance or compliance audits.

7. The instrument is limited to content specification and does not address the Secretary’s release criteria, format or frequency. The specification does not set out whether release will be bulk, incremental, in a searchable register, or as one-off published items. It is therefore uncertain, from the instrument alone, how the public will access the disclosed information in practice.

8. Repeal of the stakeholder-testing instrument. The prior Stakeholder Testing instrument is repealed in full (section 6 and Schedule 2). Sponsors who acted under that earlier instrument should confirm whether any differences between the earlier specification and this one affect what they expect to be released. The instrument does not contain a transitional statement about previously supplied data.

9. No penalty but potential reputational cost. The instrument imposes no statutory penalty for disclosure or inaccuracy (see "Penalties and enforcement"). However, sponsors should note that supplying data that will be publicly released can have commercial and reputational consequences because manufacturer and sponsor names, device identifiers and changes to intended purpose or warnings may be published.

10. Cross-reference dependency. Several fields refer to definitions existing elsewhere (for example "intended purpose", "instructions for use" and the Act’s subsection 3(1) definitions). Misunderstanding those definitions may lead to misreporting. Sponsors must read the instrument together with the cited regulatory definitions to ensure consistent reporting.

The instrument does not create new statutory duties to submit information, but it does specify information that will be releasable if provided in the named online notification form. Compliance advice below is limited to actions grounded in the instrument’s text.

1. Confirm whether your device is a "relevant kind of medical device"

• Before supplying the online notification form for the purpose of this specification, confirm that the kind of medical device is included in the Register and that the certification of the matter referred to in paragraph 41FD(f) of the Act is based on an EU MDD certificate (definition of relevant kind of medical device, section 4). The instrument’s disclosure scope is confined to those device kinds.

2. Use the specified online notification form

• The instrument ties releasable information to the online notification form named in the definitions (section 4). Use that specific form,Form: Sponsor notification for medical devices transitioning from the EU MDD to the EU MDR,accessible via the TGA Citizen Space URL given in the instrument. The instrument anchors the specification to the form "as in force or existing at the commencement of this instrument"; confirm you are using the form version intended by the TGA at or after commencement.

3. Prepare the specific fields listed in Schedule 1

• Schedule 1 item 1 lists the exact fields that are specified for release. If you choose to submit the form, ensure the following are complete and accurate:

  • Manufacturer’s name (Schedule 1, item 1(a))
  • Sponsor’s name (item 1(b))
  • Contact details for enquiries (item 1(c))
  • Name of the kind of medical device affected by transition (item 1(d))
  • Device number (item 1(e))
  • GMDN code (item 1(f))
  • GTIN (item 1(g))
  • Intended purpose (item 1(h)) , note: this term is to be read as in the Medical Devices Regulations (section 4)
  • Date of effect of the EU MDR certificate (item 1(i))
  • Details of changes in relation to prescribed matters as a result of the transition (item 1(j), and sub-items (i)-(vi) listing indications in instructions for use; class of persons for whom suitable; intended purpose; functional description; addition of warning for novel safety issue or contraindication; addition of adverse event information changing patient management recommendations)

4. Be aware that submission and release dates will be published

• Schedule 1 item 2 requires the specified kind of information to include the date the online notification form is submitted and the date of release by the TGA. Keep records of your submission date and note that the TGA will record and may publish the date of release.

5. Check identifier accuracy with GMDN and GS1 registries

• Because the instrument specifies release of GMDN code and GTIN, ensure the codes used are correct per the GMDN Agency and GS1 definitions referenced in the instrument (section 4). Incorrect identifiers will become public records if supplied.

6. Consider confidentiality and commercial sensitivity before supplying data

• The instrument does not itself provide redaction procedures for the listed fields. If the information includes commercially sensitive material, consider whether supplying it in the online notification form will expose information you prefer to keep confidential. If confidentiality protection is required, consider engaging with the TGA in advance to clarify whether the information needs to be supplied in a different manner, or whether statutory disclosure exemptions under the Act apply.

7. Coordinate internal sign-off for published fields

• Because the specified fields include sponsor and manufacturer names, contact details, device identifiers and device-purpose descriptions, implement internal procedures to confirm the accuracy and appropriateness of the content before submission. Mistakes will be public and will be accompanied by the submission and release dates detailed in Schedule 1, item 2.

8. Keep copies of submitted material

• The instrument makes submission and release dates part of the disclosed record. Retain copies of the exact material you submit to the online form, including the date and time of submission, so you can reconcile any published version. This is practical record-keeping tied to the instrument’s metadata fields.

9. Monitor TGA releases and subsequent specifications

• Because the instrument specifies content categories but not the format, timing or mechanism of publication, monitor the TGA website and Citizen Space announcements for how the Secretary implements release in practice. Also check whether the TGA issues further specification instruments updating the list of releasable fields or changing the online form version, since the instrument ties itself to the form as at commencement (section 4).

10. Seek legal or regulatory advice where necessary

• If you have concerns about whether a device is a "relevant kind of medical device", whether particular fields could be considered commercially sensitive, or how published changes (for example, changes to intended purpose or the addition of safety warnings) may affect regulatory standing, obtain specific legal or regulatory advice. The instrument itself is a content-specification tool; it does not resolve broader regulatory questions that sit elsewhere in the Act and subordinate instruments.

Concluding compliance note: The instrument’s practical effect is to make certain transition-related sponsor entries in a named online form subject to potential publication by the Secretary. Sponsors who engage with the TGA’s online notification process should approach submission as if the listed fields will become public, ensure accurate coding and descriptive content, retain records of submission, and coordinate any necessary proprietary or legal safeguards via appropriate channels external to this specification.