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Regulation impact statement: Amendments to the new regulatory framework for in vitro diagnostic medical devices (IVDs)

Version 1.0, October 2014 - OBPR Reference: 14631

17 October 2014

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If the recommendation to amend the new regulatory framework for IVDs is agreed through this RIS process, the Regulations and Act will need to be amended to address Issue 2. A legislative instrument under s.41BD(2B) of the Act specifying that IVDs used to test for predisposition or susceptibility are to be included within the definition of a medical device would be required to address issue 4 as well as minor regulatory amendments to support the current restrictions on the supply of genetic self-tests. Issue 1 has not been included in this section as it is being addressed outside the RIS process.

Stakeholders will be advised of any amendments (including through the Commonwealth Gazette, the TGA website and emails to the industry associations and stakeholders that have been contacted through the consultation).

The instrument will be tabled in Parliament and the finalised regulatory amendments will be published on the Federal Register of Legislative Instruments (FRLI).

The date of commencement will be immediate and a transition period for sponsors and manufacturers (both commercial and non-commercial) to meet the requirements will be provided.

The TGA website will include a link to the amendments on FRLI, as well as extensive advice and information for stakeholders.

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