Therapeutic Goods Information (Sharing information about in-house in vitro diagnostic medical devices) Specification 2017 [F2017L00965]-Advice only [2017] AUSStaCSDLM 314 (16 August 2017)

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Instrument	Therapeutic Goods Information (Sharing information about in-house in vitro diagnostic medical devices) Specification 2017 [F2017L00965]
Purpose	Permits the Secretary of the Department of Health to release certain therapeutic goods information that relates to in-house in vitro diagnostic medical devices to the National Association of Testing Authorities
Authorising legislation	Therapeutic Goods Act 1989
Department	Health
Disallowance	15 sitting days after tabling (tabled Senate 8 August 2017) Notice of motion to disallow currently must be given by 16 October 2017
Scrutiny principle	Standing Order 23(3)(a)

Description of consultation

Section 17 of the Legislation Act 2003 directs a rule-maker to be satisfied that appropriate consultation, as is reasonably practicable, has been undertaken in relation to a proposed instrument. The ES which must accompany an instrument is required to describe the nature of any consultation that has been carried out or,

if there has been no consultation, to explain why none was undertaken (paragraphs 15J(2)(d) and (e)).

With reference to these requirements, the committee notes that the ES for this instrument provides the following information:

The Specification is intended to support the operation of the MOU (memorandum of understanding) between TGA and NATA (as per Clause 5.7 of the MoU). The MOU was developed in consultation with NATA and facilitates the exchange of information on matters relating to the compliance of NATA-accredited laboratories engaged in the manufacture of in-house IVD medical devices with conformity assessment procedures set out in Schedule 3 to the TG MD Regulations.
The MOU is a publicly available document that can be viewed without charge on the NATA website, https://www.nata.com.au/nata/about-nata/agreements. Laboratories engaged in the manufacture of in-house IVD medical devices are aware of the MoU and upon submission of an application for inclusion (for a Class 4 in-house IVD medical device) or a notification (for Class 1-3 in-house medical devices) certify that the information provided is current and correct and acknowledge that any information provided to support an application for inclusion or notification may be shared with NATA.

While the committee does not usually interpret paragraphs 15J(2)(d) and (e) as requiring a highly detailed description of consultation undertaken, it considers that an overly bare or general description is insufficient to satisfy the requirements of the Legislation Act 2003. In this case, the ES refers to a general process of consultation that occurred in relation to the development of a memorandum of understanding and does not provide information about whether consultation was or was not undertaken specifically in relation to this instrument. In terms of complying with paragraphs 15J(2)(d) and (e) of the Legislation Act 2003, the committee's preferred approach would be for the ES to have explicitly stated that further consultation

for the instrument was considered unnecessary (or inappropriate) due to the nature of the consultation that had already taken place.

The committee's expectations in this regard are set out in the guideline on consultation published on the committee's website.^[1]

The committee draws the above to the minister's attention.

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[1] See Regulations and Ordinances Committee, Guideline on consultation, http://www.aph.gov. au/Parliamentary_Business/Committees/Senate/Regulations_and_Ordinances/Guidelines/ consultation.