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Regulation impact statement: Changes to premarket assessment requirements for medical devices

26 June 2013

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Attachment D: Previous reports and consultations

Over the past few years there have been a number of reviews and inquiries relevant to premarket assessment of medical devices. These include:

HTA review

The HTA Review report in December 2009 noted the TGA is responsible for protecting Australian consumers from health technologies which cause harm, by ensuring that goods on the ARTG are 'free from unacceptable risk'. The report recommended that the TGA, in the context of international harmonisation:

  • 8(b) respond to the issues raised in consultations regarding third party conformity assessment by July 2010, with a view to implementing changes agreed by government by 2011;
  • 8(c) increase the rigour of regulatory assessment of higher risk medical devices by 2011, to ensure an appropriate level of evidential review is undertaken to ensure safety, quality and efficacy of these devices prior to entry on the ARTG and to provide a sound evidence basis for Commonwealth HTA processes.

The HTA Review also made a number of recommendations about the post market surveillance of medical devices.

  1. That, in order to improve the contribution of post market surveillance to patient safety, the TGA take steps to increase the rate of reporting of adverse events, including by health service providers and consumers.
  2. That, in order to improve the contribution of postmarket surveillance to the sustainability of the health system and the longer-term regulatory efficiency of HTA processes, the Department of Health and Ageing (DoHA) explore options for consideration by government in 2011 to facilitate the expansion and use of post market surveillance data to inform safety, effectiveness and reimbursement decisions for devices and procedures.
  3. That registers for high risk implantable medical devices and/or procedures be established, with:
    1. key stakeholders such as clinicians, health consumers and industry to participate in governance of and contribution to registries
    2. establishment of mechanisms to apply data from the register to future HTA;
    3. the feasibility, benefits and methodologies for data linkage to be explored in a pilot project in regard to a particular device identified by the high-risk implantable devices register
    4. consideration of how developments in e-health and data linkage could improve the efficiency of the postmarket surveillance of medical technology more generally
    5. the development of criteria, the identification of opportunities and the consideration of strategies for improvements in public investment in medical devices.

Further information on the HTA Review, including a copy of the report, is available at the Department of Health and Ageing website at Review of Health Technology Assessment in Australia (HTA Review).

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TGA medical device consultation

A discussion paper on options to increase regulatory assessment of higher risk medical devices was released in October 2010, with consultations undertaken in November and December 2010, and included options to:

  • cease requiring Australian manufacturers to seek TGA conformity assessment (Proposal 2A)
  • requiring TGA conformity assessment for all high risk devices (Proposal 2B)
  • allowing conformity assessment by third party assessment bodies (Proposal 2C).

The response to this consultation was not entirely supportive of the proposals as outlined.

The 2010 consultation built upon earlier discussion papers released by the TGA in late 2008 and early 2009 in respect of the reclassification of joint replacement implants and the use of third party conformity assessment bodies for medical devices manufactured in Australia.

Further information on the 2010 TGA consultation, including the consultation paper and submissions received in response, is available at the TGA website at Reforms in the medical devices regulatory framework. Information on the previous consultations is also available on the TGA website.

Transparency review

On 20 July 2011 the Report of the Review to improve the transparency of the Therapeutic Goods Administration was released. The review had been commissioned in response to the perception in the community that the TGA does not provide the public with sufficient information about its activities and about the therapeutic goods that it regulates. The panel of consumer, health practitioners and therapeutic goods industry representatives consulted widely with persons and organisations affected by the TGA's activities.

The report outlined 21 recommendations for changes for increasing the community's trust in therapeutic goods regulation, balancing legislative obligations with the need to provide more and better information to the Australian community. The recommendations included:

Recommendation 12

The TGA explore mechanisms for providing explanations on its various regulatory processes, and adopt publication principles on the outcomes of application assessments using as an exemplar the Australian Public Assessment Reports (AusPAR).

The Government's response to the Transparency Review recommendations is contained in the TGA Blueprint. Further information on the Transparency Review, including a copy of the report, is available at the TGA website at Report of the Review to improve the transparency of the Therapeutic Goods Administration.

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TGA Blueprint

On 23 September 2011 the TGA announced that, based on previous consultations, a number of reform proposals on medical devices would proceed to consultation with key stakeholders:

  • Proposal 1: Reclassification of joint replacement implants
    • To be implemented from 1 July 2012 with a two year transition period
  • Proposal 2: Amendments to regulatory provisions relating to third party assessment bodies and implantable medical devices
    • Subject to further consultation on amended versions of Proposals 2A, 2B and 2C
  • Proposal 3 (i): Amend the way in which a kind of medical device is included in the ARTG (product name)
    • Options to be explored in consultation with stakeholders
  • Proposal 4: Publication of device product information on the TGA website (product information)
    • Options to be explored in consultation with stakeholders.

The TGA Blueprint also included in-principle agreement with consultation to be undertaken with stakeholders to further develop options in relation to Recommendation 12 of the Transparency Review.

In December 2011 these activities were incorporated into TGA reforms: A blueprint for the TGA's future. This document draws together a broad range of reform activity from across the TGA operations, and is available at TGA reforms: A blueprint for TGA's future, together with the related implementation plan which was released in July 2012, which is available at Delivering reforms - Implementation plan for TGA Reforms: A blueprint for TGA's future.

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Senate medical devices inquiry

On 16 June 2011 the Senate Community Affairs References Committee commenced an Inquiry into the regulatory standards for the approval of medical devices in Australia. The committee tabled its report on 22 November 2011, and included a number of recommendations relevant to and supportive of greater regulatory rigour in the premarket assessment of higher risk medical devices. As outlined below, in its 13 September 2012 response to this report the Government largely agreed to these recommendations.

Recommendation 2

The committee recommends that the Department of Health and Ageing fully implement Recommendation 8c of the Health Technology Assessment Review regarding the need for increased rigour of regulatory assessment of higher-risk medical devices.

Government response: Agreed.

Recommendation 3

The committee recommends that the level of assessment of Class III medical devices be increased.

Government response: Agreed to consult further with affected stakeholders.

Recommendation 4

The committee recommends that the Therapeutic Goods Administration investigate whether allowing an increasing number of medical devices onto the Australian market actually improves clinical outcomes; and whether a more judicious approach could improve premarket assessment and postmarket surveillance of higher risk medical devices, for the ultimate benefit of patients.

Government response: Agreed with the intent, to improve the quality of medical devices available in the Australian market place, by continuing to refine requirements for premarket assessment and postmarket surveillance.

Recommendation 5

The committee recommends that the Therapeutic Goods Administration continue to consult widely with stakeholders, including consumer health organisations, on the amended proposals related to third party conformity assessment; and weigh carefully considerations of the advantages of streamlined international regulatory frameworks and patient safety.

Government response: Agreed.

Recommendation 7

The committee recommends that the Department of Health and Ageing implements Recommendations 13, 14, and 15 of the Health Technology Assessment Review in a timely manner. These recommendations address the need for improved postmarket surveillance by increasing the rate of reporting of adverse events, including by health service providers and consumers; facilitating the expansion and use of postmarket surveillance data to inform safety, effectiveness and reimbursement decisions; and establishing further clinical registers for high risk implantable devices and procedures.

Government response: Agreed in principle.

Further information on the Inquiry, including transcripts of public hearings, submissions made to the committee, the Committee's report and the Government's response, are available at the Medical Devices Inquiry website.

Senate PIP inquiry

On 8 February 2012 the Senate Community Affairs References Committee also commenced an inquiry into The role of the Government and the TGA regarding the approval and monitoring of medical devices listed on the ARTG, including issues around Poly Implant Prothese (PIP) breast implants. While recommendations of this inquiry focused more on the administration of the existing regulatory framework and postmarket monitoring of medical devices, a number of recommendations were proposed for action:

Recommendation 9

The committee recommends that, in light of the PIP breast implant recall, the Department of Health and Ageing establish an opt-out Breast Implant Registry as a priority. The design of such a registry should be based on the National Joint Replacement Registry.

Recommendation 11

The committee recommends that the Department of Health and Ageing implement recommendations 13, 14 and 15 of the HTA Review recommendations as soon as possible. The committee notes this recommendation was also made in its 2011 report on regulation of medical devices (recommendation 7).

The Government has not yet responded to the PIP report.

Further information on the Inquiry, including transcripts of public hearings, submissions made to the committee and the Committee's report, are available at the PIP Inquiry website.

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