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Consultation: Changes to premarket assessment requirements for medical devices: Proposal paper

14 January 2013

This consultation opened on 14 January 2013 and closed on Friday 15 March 2013.

Consultation documents

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This document was released for consultation on Monday 14 January 2013.

Interested parties responded by close of business Friday 15 March 2013.

Feedback will be released following consideration of submissions (see Submissions received).

About the consultation

This proposal paper sought to:

  • refine a risk-based approach to regulation;
  • ensure that the TGA undertakes a more comprehensive review of higher risk medical devices, in particular implantable and surgically invasive medical devices intended for long term use;
  • increase transparency and accountability of the TGA's decision making; and
  • allow Australian manufacturers of lower risk medical devices to have the option of European Conformity assessment for supply of their devices in Australia.


This paper has been produced in response to the recommendation in the TGA Blueprint for further consultation on medical device regulation and progresses proposals 2A, B and C and Proposal 4 arising from the HTA Review.

The recurring themes in these reports is that Australia must increase its level of premarket assessment for higher risk medical devices, especially those which are implanted or inserted into the body for a significant period of time.

This paper details the following proposals:

  • 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 class medical devices.

The paper takes into account the feedback from earlier consultations, findings from the Senate Inquiries, and the shift that has occurred in the international context of medical device regulation since the 2010 consultations.

Content of submissions

Stakeholders were invited to address any, or all, of the proposed changes to premarket assessment of implantable medical devices or other identified issues.

Stakeholders were also invited to address the queries included throughout the proposal paper in a number of boxes.

In addition, submissions were invited to include:

  • suggested improvements or alternatives to proposed changes;
  • whether or not you support the specific proposals or combinations of proposals. If you do not support the proposals you may make suggestions for an alternative acceptable to you; and
  • an assessment of how the proposed change will impact on you. That is, what do you see as the likely benefits or costs to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits. Any proposals which proceed will be the subject of further consultation to inform a Regulation Impact Statement (RIS), and any initial comments you can make will assist in developing that RIS process.


Enquiries should be directed to Kate Lawrence via email to or by telephone on 02 6232 8781.

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