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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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The proposed amendments to the IVD framework have been subject to extensive consultation with stakeholders, including:

  • initial consultations from 2012 to the first quarter of 2013 with key stakeholders
  • a first round of consultation on specific reform proposals that commenced on 3 May 2013 by publicly releasing a consultation paper, 'Proposed Amendments to the New Regulatory Framework for In Vitro Diagnostic Medical Devices (IVDs)' on the TGA website. The consultation period was initially four weeks (until the end of May 2013). This period was extended by another week until 7 June 2013 to provide more time for individuals and groups interested to make a submission. The consultation paper sought to address a number of outstanding issues that were identified during the transition period to the new regulatory framework and the initial consultations and
  • a second round of consultations that engaged the commercial IVD sector, testing laboratories and bodies or individuals associated with the IVD sector through one-on-one meetings, forums and conferences. These consultations provided further opportunities to consult with stakeholders and receive feedback on the proposed amendments. It was also an opportunity to discuss any outstanding issues that were not covered off in the first round consultations that may need to be included in the final RIS. These discussions were invaluable in informing the final proposals presented in this RIS.

As noted in the introduction, this process started well before any changes were made to the process provided in the June 2010 Best Practice Regulation Handbook and the commencement of The Australian Government Guide to Regulation. Consequently, the TGA did not submit the RIS for an early assessment however it considers that the release of a consultation paper and extensive face-to-face consultation with stakeholders means that the TGA has complied with the intent of the current RIS process. In particular the consultation paper:

  • included discussion of the problem, objectives and options - the minimum three elements of an options-stage RIS
  • included various options for reform including the option of no change however the regulatory burden was not quantified for each option and
  • was released on the basis that the responses to the proposals would assist the TGA in determining the changes required for laboratories, manufacturers and sponsors to comply with the new regulatory framework, and it did not represent the TGA’s final view on the issues raised.

Thirty-four submissions to the consultation paper were received by the TGA representing four main stakeholder groups: consumers (1); laboratories (16); industry (12); and peak bodies or individuals associated with the IVD sector (5).

Summary of Main Comments from Stakeholders on Proposed Amendments
Issue Summary of main comments
Issue 1 There was no opposition to the proposed extension of the transition timeframe. Laboratories and industry are experiencing difficulties meeting the new regulatory requirements.
Issue 2

The majority of stakeholders acknowledged and supported the need for change to the CA procedures.

Industry acknowledged the need for changes to the CA procedures for Class 4 in-house IVDs however were disappointed that the proposed amendments did not extend to the commercial sector and were concerned the changes would create an ‘uneven playing field’ (for a period of time).

Laboratories welcomed the proposed amendments but still had concerns regarding the regulation of IVDs required to deal with public health emergencies and the need for exemptions for special purposes and circumstances.

consumer group did not want to see any changes made to the CA procedures and were concerned that any changes would result in a reduction in the quality of the IVDs available on the Australian market.

Issue 3 The majority of stakeholders supported selective performance evaluation for certain Class 4 IVDs however commercial industry had reservations that this would result in an extra delay to market and only accepted the proposal on the understanding that the TGA would need to provide clear guidance on what Class 4 IVDs would be selected.
Issue 4 The majority of stakeholders supported the need to regulate tests for predisposition and susceptibility to disease due to the potential ramifications on patient health and treatment options. Some concerns were expressed that the regulation of these tests could result in the removal of some IVDs from the Australian market.

Further to this, the TGA also undertook two surveys to attempt to elicit information from both the commercial IVD sector and testing laboratories about the number and anticipated timing of transitioning IVDs and to identify any IVDs at risk of not being available in Australia at the end of the transition period.

The majority of stakeholders that participated in the consultation process recognised the outstanding issues for complying with the IVD framework, and were agreeable to amendments being progressed to support compliance with the new requirements for IVDs.

The preferred proposals developed in this RIS also took into consideration the response of IVD stakeholders to consultation papers proposing changes to premarket assessment requirements for medical devices that were released on 14 January 2013 (Changes to premarket assessment requirements for medical devices: Proposal paper) and 10 May 2013 (Changes to premarket assessment requirements for medical devices).

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