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Consultation: Regulation Impact Statement: Changes to premarket assessment requirements for medical devices

10 May 2013

This consultation closed on 3 June 2013.

This document was issued as an exposure draft of the RIS which has been presented to the Parliamentary Secretary for Health and Ageing, the Hon Shayne Neumann MP, who is responsible for matters relating to the Therapeutic Goods Administration.

The document was released for comment, input and feedback from all parties affected by these reforms.

While the final RIS was edited based on feedback and input received, the intention was to maximise transparency by circulating a draft similar to the final document provided to Government. Some sections, such as the analysis of costs, required industry input to be completed, and so were expected to be edited substantially before the document was finalised. Some of these expected changes were noted by editing comments included in the exposure draft, included in <<< purple bold text >>>.

Consultation documents

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This document was released for consultation on 10 May 2013.

Interested parties responded by close of business 3 June 2013.

Submissions have been released following consideration by government as part of the Regulation Impact Statement process (See Submissions received).


A paper, Changes to premarket assessment requirements for medical devices, was released by the TGA on 14 January 2013, with consultation closing on 15 March 2013. The paper outlined three proposed regulatory reforms for premarket assessment of higher risk medical devices:

  • Proposal A: Increased scrutiny of conformity assessment as part of mandatory application audits prior to ARTG inclusion;
  • Proposal B: Publication of medical device regulatory decisions; and
  • Proposal C: Abolition of requirement for TGA conformity assessment for Australian manufacturers of lower risk medical devices.

The RIS exposure draft aimed to assist in Government decision making on how to progress the proposals outlined in that earlier paper.

Content of submissions

Stakeholders were invited to address any, or all, of the proposed options and other issues identified in the RIS exposure draft. In addition, stakeholders were invited to include information on:

  • suggested improvements or alternatives to proposed options;
  • whether or not they support the specific options. If they did not support the options, suggestions for an alternative acceptable to them;
  • an assessment of how implementation of option 2 (the preferred option) would impact on them. That is, what did they see as the likely benefits or costs to them (these may have been financial or non-financial). Stakeholders were asked, if possible, to attempt to quantify these costs and benefits.


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