Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015 [F2015L01791]-Response required [2015] AUSStaCSDLM 248 (2 December 2015)

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Instrument	Therapeutic Goods (Medical Devices) Amendment (In Vitro Diagnostic Medical Devices) Regulation 2015 [F2015L01791]
Purpose	Amends the Therapeutic Goods (Medical Devices) Regulations 2002 to provide alternative conformity assessment procedures for Class 4 in-house in vitro diagnostic medical devices
Last day to disallow	29 February 2016
Authorising legislation	Therapeutic Goods Act 1989
Department	Health
Scrutiny principle	Standing Order 23(3)(a)

Unclear basis for determining fees

The regulation amends the Therapeutic Goods (Medical Devices) Regulations 2002 to provide alternative conformity assessment procedures for Class 4 in-house in vitro diagnostic medical devices (IVD). The committee notes that item 10 of the regulation introduces two application audit fees for Class 4 in-house IVDs required to undergo an application audit. The application audit fee is $59 900 for Class 4 in-house IVDs that are an immunohaematology reagent IVD and $14 600 for other Class 4 in-house IVDs. However, the ES does not explicitly state the basis on which the fees have been calculated for this new category of circumstances.

The committee's usual expectation in cases where an instrument of delegated legislation carries financial implications via the imposition of or change to a charge, fee, levy, scale or rate of costs or payment is that the relevant ES makes clear the specific basis on which an individual imposition or change has been calculated.

The committee requests the advice of the minister in relation to this matter.

Access to extrinsic material

Item 9 of the regulation inserts new section 6B.3 into the Therapeutic Goods (Medical Devices) Regulations 2002. The new section incorporates by reference ISO 15189, Medical laboratories—Requirements for quality and competence, published by the International Organization for Standardization, as amended from time to time.

The committee's expectations where provisions allow the incorporation of legislative provisions by reference to other documents accord with the approach of the Senate Standing Committee on Scrutiny of Bills, which has consistently drawn attention to legislation that incorporates extrinsic material that is not readily and freely available to the public. Generally, the committee will be concerned where relevant information, including standards or industry databases, is not publically available or is available only if a fee is paid, such that those obliged to obey the law may have inadequate access to its terms.

In this respect, the committee notes that ISO 15189, Medical laboratories—Requirements for quality and competence is published by and available for sale from the International Organization for Standardization for a fee of CHF178.^[1] However, neither the instrument nor the ES provide information about whether the standard is otherwise freely and readily available.

The committee requests the advice of the minister in relation to this matter.

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[1] As at 1 December 2015, CHF 178 (178 Swiss Franc) converted to approximately AUD $240.