Therapeutic Goods Information (Sharing information about in-house in vitro diagnostic medical devices) Specification 2017

This Specification authorises and limits the disclosure by the Secretary of the Therapeutic Goods Administration of therapeutic goods information that relates to in-house in vitro diagnostic medical devices, to a single external body, the National Association of Testing Authorities, Australia, for stated public health and safety purposes. The instrument is made under subsection 61(5AB) of the Therapeutic Goods Act 1989 and operates to identify the kinds of information, the recipient body and the permitted purposes for release, as required by subsection 61(5AA) of the Act (see the operative provision at section 4 of the Specification and the Schedule). The Specification commenced the day after it was registered (s 2) and was made by a delegate of the Minister for Health (preamble).

Mechanically, the Specification performs three linked tasks. First, it adopts and fixes the definitions necessary to read the instrument, by cross‑referencing core terms to the Medical Devices Regulations 2002 and defining shorthand for ARTG, NATA and TGA in section 3. Second, it identifies and confines the universe of therapeutic goods information that the TGA may disclose to NATA: discrete categories of material set out in Schedule 1 (items (a)-(d)). Third, it states the recipient (NATA) and the permitted objective for disclosure , to facilitate the sharing and considering of information in the interest of public health and safety, particularly concerning the quality, safety or performance of in‑house IVDs manufactured by NATA‑accredited laboratories (Schedule 1, Persons and Purposes).

The Specification is explicit that references in the Schedule to particular clauses are to clauses in a Memorandum of Understanding between the Commonwealth and NATA dated 2 September 2016 (Schedule 1, Note 2). The Schedule therefore links the legal authorisation contained in the Act to an operational arrangement captured in the MoU. The instrument uses permissive language: the Schedule notes that the specified kinds of information "may be released by the Secretary under subsection 61(5AA) of the Act" to the specified body for the specified purposes. The document therefore creates a defined, discretionary channel for information flows between the TGA and NATA limited to enumerated categories and to support listed activities such as accreditation assessment, development of guidance, and post‑market investigations (Schedule 1, item descriptions).

In short, the Specification is a narrow data‑sharing authorisation: it does not create a new regulatory obligation directly on laboratories, but it changes who can receive TGA‑held material and for what purposes. The immediate effect is to enable the TGA Secretary, where they choose to do so, to disclose specified TGA information about in‑house IVDs and NATA‑accredited laboratories to NATA under the legal pathway provided by ss 61(5AA) and 61(5AB) of the Act (s 4 and Schedule 1).

The Specification revolves around a small set of legal and operational concepts that determine its scope and functioning. These include the legal basis for disclosure, the referential definitions, the categories of information identified for release, the recipient body, and the limited purposes for which disclosure is authorised.

Legal basis and discretionary release. The instrument is made under subsection 61(5AB) of the Therapeutic Goods Act 1989 and specifies kinds of therapeutic goods information, persons and purposes for the purposes of subsection 61(5AA) of the Act (s 4). The Schedule expressly states that the specified kinds of information "may be released by the Secretary under subsection 61(5AA) of the Act" to the specified body for the specified purposes. That language signals that release is discretionary rather than mandatory and that the instrument creates a permissible class of disclosures rather than an obligation to disclose each item of information that falls within the classes.

Referential definitions. Section 3 defines ARTG and TGA in situ and imports the statutory meaning of "IVD medical device" and "in‑house IVD medical device" from the Therapeutic Goods (Medical Devices) Regulations 2002, by stating they "have the same meaning as in the MD Regulations." This means the Specification’s reach moves automatically with any change to the MD Regulations’ definitions. NATA is defined as the National Association of Testing Authorities, Australia, and is the only external recipient authorised by the instrument.

Enumerated information categories. Schedule 1 identifies four principal categories of therapeutic goods information that may be shared:

• Information relating to the assessment of laboratories engaged in the manufacture of in‑house IVDs (item (a)), with an example linking this to use of existing NATA accreditation to support an ARTG inclusion application (see the reference to MoU clause 5.1(c)).
• Information about trends in technology and laboratory practice for in‑house IVDs, including clinical utility, misuse or performance (item (b); MoU clause 5.5).
• Information relating to TGA concerns about the performance or competence of NATA‑accredited laboratories manufacturing in‑house IVDs, exemplified by adverse events (item (c); MoU clauses 6.9 and 7.6).
• Laboratory‑specific lists and records: lists of Class 1-3 devices being manufactured and dates of the laboratory’s last notification to the TGA; lists of Class 4 devices; details of any assessments of technical or scientific data supporting Class 4 devices provided with ARTG inclusion applications; details of any post‑market investigations and related technical data, and information required by MD Regulations post‑market notification provisions (item (d); MoU clause 7.2 and MD Regulations Schedule 3 paragraphs cited).

The Specification directly affects three categories of actors: the Secretary/TGA as the information controller and decision maker for releases, NATA as the authorised recipient and user of the shared information, and laboratories that manufacture in‑house IVDs, particularly those that are NATA‑accredited or seeking ARTG inclusion for Class 4 in‑house IVDs. It also has indirect effects on clinicians, patients and other stakeholders insofar as information sharing may influence accreditation outcomes, guidance and post‑market responses.

The Secretary/TGA (decision maker). The Specification authorises the Secretary to release the specified kinds of therapeutic goods information under subsection 61(5AA) (s 4; Schedule 1 note 1). This makes the Secretary the gatekeeper: they control whether any particular item of TGA‑held information will be disclosed to NATA. The TGA therefore bears implementation costs and responsibilities: identification, collation, redaction if required, secure transfer and record‑keeping of disclosures. The instrument does not itself set procedural standards for how the Secretary should exercise this discretion; those procedural details are expected to be managed under the MoU and the TGA’s internal administrative processes.

NATA (recipient). NATA is the sole external recipient identified (Schedule 1, Persons). The Specification permits NATA to receive a defined set of TGA information to inform accreditation assessments and related activities. NATA’s accreditation work and assessment planning will be affected, because it can request or be provided TGA information such as lists of devices, dates of notifications, technical and scientific data supplied with ARTG applications, adverse event information and trend analyses. The MoU clauses referenced in the Schedule will govern how NATA uses, stores and acts on the information; the Specification itself authorises the transfer but defers procedural detail to the MoU.

Laboratories manufacturing in‑house IVDs (subject labs). Laboratories that manufacture in‑house IVDs are the subjects of the information authorised for disclosure. The Schedule specifically contemplates information that laboratories are required to notify the Secretary under the MD Regulations (paragraphs 6A.4(2)(c) and 6B.5(2)(c) of Schedule 3 to the MD Regulations are cited). Laboratories will therefore be indirectly affected in three main ways:

• Accreditation interactions: NATA will be able to combine TGA‑held information with its accreditation activities, which may influence the content and timing of accreditation assessments. The Schedule gives the example of TGA notifi cations being shared to assist NATA prepare for an accreditation assessment (item (d)).

The Specification itself does not create new direct duties on laboratories beyond what the MD Regulations already require; instead, it delineates permitted flows of TGA‑held information and thereby creates rights and obligations pertinent to disclosure, receipt and use of that information.

Secretary’s rights and obligations. The Secretary gains a statutory authorisation to disclose identified categories of information to NATA under subsection 61(5AA) of the Act, as specified by this instrument (s 4; Schedule 1). The instrument uses permissive language: the Secretary "may" release the listed information, indicating an authorised discretion rather than a compulsion to disclose. The Specification does not set procedural duties, timelines, or thresholds for release. Therefore the Secretary retains discretion on whether and when to disclose particular items, but must act within the confines of the Specification (only the kinds of information listed, only to NATA, and only for the purposes described). Any exercise of the Secretary’s discretion will be subject to general administrative law constraints, though those are not expressed in the Specification.

TGA’s operational duties. While not expressed in the instrument text, the Schedule’s linkage to MoU clauses implies operational responsibilities to coordinate with NATA. The examples in Schedule 1 (for example, sharing notifications to assist NATA prepare for accreditation) indicate that the TGA will need to identify relevant TGA records (e.g., device notifications, post‑market investigation reports, assessment notes), compile them in transferable form, and effect disclosure in accordance with the MoU. The Specification itself does not create recordkeeping or redaction rules; those are practical duties likely to be implemented administratively.

NATA’s rights and implied obligations. As the sole authorised recipient, NATA has the right to receive TGA information that falls within the listed categories. That receipt is framed to facilitate accreditation assessments, guidance development and consideration of laboratory performance. The Specification references clauses of the MoU that will govern the practical relationship; those MoU clauses likely impose handling, confidentiality and use constraints on NATA, although the Specification does not recite them. NATA’s responsibilities will therefore be primarily contractual and procedural, exercised under the MoU.

Laboratory obligations under existing law. The Schedule explicitly includes "information of a kind which the laboratory is required to notify the Secretary" under the post‑market system requirements of Schedule 3 to the MD Regulations (Schedule 1, item (d)). That reference signals that laboratories continue to be bound by their MD Regulations obligations to notify the Secretary of certain matters. The Specification does not change those notification duties, but it clarifies that information supplied to meet those duties may be disclosed by the Secretary to NATA.

The Specification is not a penalty‑imposing instrument. It is a specification under subsection 61(5AB) of the Therapeutic Goods Act 1989 identifying kinds of information, persons and purposes for the purposes of subsection 61(5AA). The text itself does not create criminal or civil penalties, nor does it amend existing enforcement provisions in the Act or the MD Regulations. It therefore alters information‑sharing authorisations rather than adding substantive offences or pecuniary penalties.

Enforcement of disclosure obligations. Because the instrument authorises discretionary disclosures by the Secretary, enforcement in the sense of compelling the Secretary to disclose particular items is not provided for in the Specification. Similarly, the instrument does not specify remedies for third parties (including laboratories) if the Secretary discloses information in contravention of other legal obligations. Any legal challenge to the Secretary’s use of the discretionary power would be a matter for administrative law and judicial review in the ordinary way, grounded in the Act and general administrative law principles, not in the Specification itself.

NATA’s compliance obligations and accountability. The Specification does not set out sanctions for NATA misuse or mishandling of information. The Schedule’s references to MoU clauses indicate that obligations on NATA and corresponding accountability measures are likely to be contained in the MoU and in any contractual or administrative arrangements with the Commonwealth. Enforcement mechanisms for breaches by NATA would therefore be found in those documents and general law, not in the Specification text.

Laboratory reporting and MD Regulations enforcement. The instrument references instances where laboratories are required to notify the Secretary under the post‑market system requirements of Schedule 3 to the MD Regulations (paragraph 6A.4(2)(c) for Class 1-3 and paragraph 6B.5(2)(c) for Class 4 devices). Any enforcement of those notification duties, including penalties for non‑compliance, would be governed by the MD Regulations and the Therapeutic Goods Act rather than by this Specification. The Specification has the practical effect that information reported under those MD Regulation provisions may be disclosed to NATA.

Recordkeeping, transparency and internal accountability. The Specification itself does not require the Secretary to keep a public register of disclosures made under it, nor does it require the TGA to publish the MoU. The Note at the end reminds readers that legislative instruments are registered on the Federal Register of Legislation, but the instrument leaves internal recordkeeping and public transparency to existing administrative practice or to provisions in the MoU.

The Specification is explicitly drafted as an instrument that operates within and by reference to other statutory instruments and agreements. Its interaction with the Therapeutic Goods Act 1989, the Therapeutic Goods (Medical Devices) Regulations 2002, Schedule 3 of those Regulations, and the Commonwealth-NATA Memorandum of Understanding is central to its legal effect.

Statutory parentage and operational authority. The Specification is made under subsection 61(5AB) of the Therapeutic Goods Act 1989 (preamble and s 4). It performs the specific function required by subsection 61(5AA) of the Act , namely, to specify kinds of therapeutic goods information, persons and purposes for which the Secretary may release information. The Specification does not alter substantive duties in the Act; rather, it delineates the scope of authorised disclosure of TGA‑held information consistent with the Act’s framework.

MD Regulations and device definitions. Section 3 imports the MD Regulations’ definitions of "IVD medical device" and "in‑house IVD medical device," so the Specification’s subject matter is defined consistently with the MD Regulations. Because these terms are not defined in the Specification but by reference, any amendment to the MD Regulations that alters those definitions will also alter the set of devices to which the Specification applies. The instrument therefore has a structural dependence on the MD Regulations for its subject matter boundaries.

Post‑market notification obligations. The Schedule refers to paragraph 6A.4(2)(c) (for Class 1, 2 or 3 in‑house IVDs) and paragraph 6B.5(2)(c) (for Class 4 in‑house IVDs) of Schedule 3 to the MD Regulations as sources of the kinds of information that may be shared (Schedule 1, item (d)). Those references mean the Specification interfaces with laboratories’ statutory obligations to notify certain matters; information that arises under those obligations is caught by the Specification’s authorised disclosures.

Memorandum of Understanding. The Schedule explicitly notes that references to clauses are references to clauses in the MoU between the Commonwealth and NATA in relation to in‑house IVDs dated 2 September 2016 (Schedule 1, Note 2). Several Schedule items specify clause numbers from that MoU (for example, clause 5.1(c), clause 5.5, clauses 6.9 and 7.6, clause 7.2 and clause 7.3). Practically, the MoU will operationalise the Specification: it will determine how the TGA and NATA coordinate, what data formats and protections apply, and how the information is to be used. The Specification therefore functions as a statutory authorisation that is intended to be exercised pursuant to contractual or administrative terms in the MoU.

The Specification is dated 25 July 2017 and signed by the delegate of the Minister for Health (preamble). It commences the day after registration (s 2). The text provided contains no amendments or later notation of amendment. Therefore, based on the instrument text alone, the amendment history is as follows:

• Original instrument made on 25 July 2017 by the Minister’s delegate and registered to commence the day after registration (preamble and s 2).

The instrument contains a Note directing readers to the Federal Register of Legislation for registration and compilation of legislative instruments (end note). That suggests that any subsequent amendments, repeal or replacement would be recorded on the Federal Register of Legislation under the Legislation Act 2003 framework. The Specification itself contains no amendment clauses, no expiry date, and no review provision.

Because the Specification imports definitions from the MD Regulations and cross‑references clauses of an MoU, its effective scope can change in two ways that do not require formal amendment of this instrument:

• Changes to the MD Regulations’ definitions of "IVD medical device" or "in‑house IVD medical device" will automatically change the population of devices to which the Specification relates due to the express importation in s 3.
• Changes to the MoU or to the content of the MoU clauses referenced may change operational arrangements governing how the information authorised by the Specification is handled; however, such changes to the MoU will not amend the legal authorisation in this Specification unless the MoU leads to re‑specification or further legal instruments.

If a reader requires the current and complete amendment history, the Note at the end of the Specification directs them to the Federal Register of Legislation where the instrument and any subsequent amendments would be registered.

The Specification text does not record any litigation. There are no cases, proceedings, or judicial decisions referenced in the instrument. The instrument does not indicate that it has been the subject of any judicial review or legal challenge. Consequently, based solely on the material in this instrument, there is no recorded litigation history to report.

That absence in the text means two points for practitioners to note. First, there is no statutory case law in the instrument to clarify contours such as the scope of the Secretary’s discretion to disclose, the handling of confidential commercial information, or the procedural expectations for notice to affected laboratories. Second, any legal disputes about exercise of the Secretary’s discretion, alleged misuse of disclosed material by NATA, or interactions with MD Regulations would proceed in the ordinary way through administrative law and relevant civil or contractual remedies. Such potential litigation would be grounded in the Act, the MD Regulations, the MoU and general law, but that litigation history is not reflected in this Specification itself.

Practitioners seeking precedent or judicial interpretation will therefore need to look beyond the instrument to administrative law decisions or to any litigation in which the TGA, NATA or affected laboratories have been parties. The Specification does not provide such case citations.

This Specification appears straightforward, but a number of practical and legal issues arise from its language, cross‑references and omissions that practitioners should flag for clients and risk registers.

Discretionary "may" versus mandatory clarity. The Schedule repeatedly uses "may be released by the Secretary" language (Schedule 1, Note 1). That creates uncertainty about when the Secretary will disclose. Laboratories cannot assume disclosure will occur, nor that they will be notified or consulted before release. Parties looking for predictable, routine data exchange should be aware that the authorisation is permissive and that the Secretary may decline to disclose particular items.

Scope moves with other instruments. The Specification imports definitions from the MD Regulations (s 3). Any amendment to the MD Regulations’ definitions of "IVD medical device" or "in‑house IVD" alters the scope of this Specification automatically. That can be an operational gotcha: the set of affected devices is not fixed by the Specification itself but by an external instrument that can be varied.

Confidentiality expectations. The instrument plainly allows the Secretary to disclose technical and scientific data provided by applicants for ARTG inclusion and post‑market investigation material (Schedule 1, item (d)). Laboratories that submit proprietary technical data to the TGA may therefore find that such material can be shared with NATA. The Specification does not set redaction or confidentiality standards, nor does it create a right to prior notice of disclosure. Laboratories should therefore treat submissions to the TGA as potentially accessible to their accreditation body and prepare to manage commercial sensitivity accordingly.

Operational dependence on the MoU. The Schedule’s note states that clause references are to clauses in the Commonwealth-NATA MoU (Schedule 1, Note 2). That means practical details on how information will be transferred, how it will be used by NATA, retention and security arrangements, and any limits on onward disclosure are likely to be determined by the MoU rather than the Specification. If the MoU is not publicly available or lacks detail, stakeholders will face uncertainty about process and safeguards.

Narrow recipient list. The Specification authorises disclosure to NATA only. That limits flexibility. If another body (a state health department, another accreditation body or a research entity) needs access to similar TGA information, the current instrument does not provide that authority. Anyone assuming broader sharing is authorised will be mistaken.

No procedural protections specified. The Specification is silent on notice, consultation, appeal rights, redaction, data security standards, or logging of disclosures. These are material for both TGA operations and for laboratories that may be affected. The absence of procedural detail places implementation risk on the TGA and leaves affected parties uncertain about protections.

Given the Specification’s structure and the interplay with the MD Regulations and the Commonwealth-NATA MoU, compliance for affected parties divides into three practical streams: (1) what the TGA should do to operationalise authorisations; (2) what NATA should do to receive and use disclosed information lawfully and effectively; and (3) what laboratories should do to manage disclosure risk and regulatory interactions.

For the TGA (Secretary and Departmental units)

• Implement a written disclosure policy for s 61(5AA) releases. Although the Specification authorises disclosure, it does not set administrative processes. The TGA should adopt documented criteria for exercise of the "may" discretion, including thresholds for public interest, safety concerns, or accreditation need. The policy should reference the Specification (s 4 and Schedule 1) and the MoU clauses cited in Schedule 1.
• Recordkeeping and audit trails. Maintain a central register of all disclosures made under this Specification, including date, recipient, categories and reasons for disclosure, and copies of disclosed material or redacted indices. This will aid accountability and respond to any administrative law review requests.
• Data handling and redaction standards. Establish procedures for reviewing TGA material for personal data and commercially sensitive information before disclosure. Decide what will be redacted and document legal bases for redactions. The Specification permits release of technical data, but privacy and confidentiality laws still apply.
• MoU alignment. Ensure the TGA’s operational processes (secure transfer, retention, notice to laboratories, dispute resolution) align with the MoU clauses referenced in the Schedule. If the MoU is silent on particular points, document decisions and legal advice.
• Notification practices. Determine whether and when laboratories will be notified before disclosure to NATA. Although not required by the Specification, a consistent notification practice will reduce surprise and potential disputes.
• Security and access controls. Use secure channels for transfer, specify storage and access limitations within the TGA and with NATA, and require destruction or return of material according to agreed retention schedules.

For NATA

• Handling, confidentiality and use policies. Adopt and document strict internal controls on the use of TGA information, including limits on onward disclosure, staff access controls, training and breach response protocols. The MoU clauses referenced will be central; NATA should ensure they are operationally effective.