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Consultation: Proposed amendments to the new regulatory framework for In Vitro Diagnostic medical devices (IVDs)

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3 May 2013

This consultation closed on 7 June 2013

The TGA sought comments from interested parties on the consultation paper: Proposed amendments to the new regulatory framework for In Vitro Diagnostic medical devices (IVDs).

Consultation documents

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Document released for consultation on Friday 3 May 2013.

Interested parties should respond by close of business Friday 7 June 2013.

Feedback will be released following consideration of submissions. (see 'What will happen').

About the consultation

This consultation paper seeks to address a number of outstanding issues that have been identified during the transition period of the new regulatory framework for IVDs, namely:

  • the ability to meet the timeframe for valid applications for inclusion in the ARTG;
  • the capacity to comply with the new regulatory requirements for Class 4 in-house IVDs;
  • the omission of the provision for performance evaluations for design examinations; and
  • the omission of tests for predisposition or susceptibility to disease from the definition of a medical device.

For further information on the new regulatory framework see 'Background'.

This consultation paper does not represent the TGA's final view on the issues raised. Stakeholders' responses to the proposals will assist in determining the changes required to enable manufacturers, sponsors and laboratories to comply with the new regulatory framework for IVDs.


The new framework for IVDs commenced on 1 July 2010 and comes into full effect at the end of a four year transition period on 30 June 2014. It was introduced to ensure IVDs undergo a level of regulatory scrutiny that is commensurate with the risk associated with their use.

All IVDs, whether previously (prior to 1 July 2010) registered, listed or exempt, are to be regulated under the new framework from 1 July 2014. This includes tests for serious infectious diseases, tests for screening blood, tissues and organs and cellular products for safety and compatibility, pregnancy tests, glucose monitors, and genetic tests (with the exception of those that do not have a therapeutic purpose e.g. kinship testing).

The new framework encompasses both commercially manufacturer IVDs as well as in-house IVDs (those IVDs developed or modified by providers for use in their own laboratories).

Content of submissions

Submissions may address any, or all, of the proposed amendments to the new regulatory framework or other identified issues.

Throughout the paper there are a number of boxes. These include questions which you may wish to use as prompts when preparing your submission.

In addition, submissions might include:

  • suggested improvements or alternative 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 changes will impact on you. That is, what you see as the likely benefits or cost to you (these may be financial or non-financial). If possible, please attempt to quantify these costs and benefits. Your comments will assist in developing the regulatory impact statement (RIS) and the cost recovery impact statement (CRIS).

What will happen?

The submissions received by the TGA will be taken into consideration in order to prepare a Regulation Impact Statement (RIS) and progress the new regulatory framework for IVDs.

The TGA will continue to improve its existing regulatory processes for IVDs. These include improvements such as streamlining business processes, targeting efforts to risk and clarifying expectations of manufacturers, sponsors, laboratories and users through improved guidance materials, and ensuring that all relevant information is available on the TGA website.


All submissions will be placed on the TGA website unless marked 'IN CONFIDENCE'. Any confidential material contained within your submission should be provided under a separate cover and clearly marked 'IN CONFIDENCE'. Reasons for a claim to confidentiality must be included in the space provided on the TGA submission coversheet.

For submissions made by individuals, all personal details other than your name will be removed from your submission before it is published on the TGA's website.

In addition, a list of parties making submissions will be published. If you do not wish to be identified with your submission you must specifically request this in the space provided on the submission coversheet.


Enquiries should be directed to the IVD Stream Leader, Michelle McNiven by email to or by telephone to 02 6232 8281.