Public consultation: Proposed application audit framework for medical devices

Closed 4 Sep 2023

Opened 26 Jul 2023

Feedback updated 17 Jun 2024

We asked

We invited feedback on a proposed risk-based application audit framework for medical devices, including In Vitro Diagnostic (IVD) medical devices. The framework described how we proposed to select medical device applications for audit and conduct those audits.

The key elements of the proposed application audit framework included:

  • risk factors informing non-mandatory audit selection,
  • criteria for mandatory audits,
  • the evidence to be provided with applications to inform audit selection,
  • limiting the number of substantial assessment rounds,
  • mechanisms to improve visibility of application audit timeframes
  • cost recovery measures for non-mandatory audits, and
  • pathways for Class III devices with Medical Device Single Audit Program (MDSAP) certification and US FDA 510(k) approval.

You said

We received twenty-six (26) submissions.

The overall level for the proposed new risk-based application audit framework was positive with broad support for:

  • limiting mandatory audits to Class III, Class 4 IVD, Class 3 IVD, point-of-care and self-test IVD medical devices
  • exempting medical devices with recognised comparable overseas regulator approvals from mandatory audit
  • establishing a new mandatory audit pathway for Class III medical devices with MDSAP and US FDA 510 (k) approval
  • repealing clause 5.3(1)(j)(viii) in the Regulations, relevant to IVD medical devices, because it is ambiguous and non-transparent in its operation.

Most respondents supported the proposal for the TGA to publish risk factors that influence non-mandatory audit selection, but they wanted more clarity about the rationale for the proposed risk factors and how each risk factor would be weighted and combined to influence the audit selection decision.

Most respondents expressed concerns about:

  • requiring applicants to submit the Instructions for Use and the Clinical Evaluation Report for Class III devices with European Medical Device Regulation certification
  • limiting audits to two substantial rounds of review.

Most respondents suggested improvements to the application audit process, including improved communication, transparency, and timeframes. Respondents said we should not delay improvements while we deliver the TGA digital transformation project.

We did

The consultation responses supported the proposed changes to the criteria for mandatory audits and the proposed MDSAP and US FDA 510(k) pathway. The TGA is seeking Government approval to amend the legislation accordingly.

Next Steps

The TGA is also using the feedback from the consultation to:

  • develop detailed guidance on the risk factors we will consider when selecting applications for audit. Once the guidance is published, we will review the risk factors periodically
  • do further work to review the evidence we require to be provided with applications to inform audit selection. We will review the requirement for applicants to provide clinical evidence for all class III medical device applications with comparable overseas regulator approval
  • improve the way we communicate with applicants about these audits
  • improve assessment timeframes for these audits, including considering establishing target timeframes.

Results updated 17 Jun 2024

Below are the individual responses published in accordance with the consent provided by nineteen (19) of the twenty-six (26) respondents.

Files:

Overview

The Australian Government is undertaking a significant program of reform to the regulation of therapeutic goods in Australia. As part of the Australian Government Department of Health, the Therapeutic Goods Administration (TGA) regulates therapeutic goods, and is responsible for implementing the Government’s reforms. We have issued this consultation paper as part of the reform program.

The TGA is responsible for regulating the import, export, and supply of medical devices, including in vitro diagnostic (IVD) medical devices in Australia.

The TGA assesses medical device applications against the regulatory requirements specified in the Therapeutic Goods Act 1989 and the Therapeutic Goods (Medical Devices) Regulations 2002 (the Regulations). Some applications are audited, which is a more thorough assessment.

We are seeking feedback on how we select medical device applications for audit and how we conduct these audits.

Consultation paper 

Public consultation - Proposed application audit framework for medical devices 

Making a submission

To make a submission:

  1. Read the consultation paper about the proposed application audit framework for medical devices (see link above).
  2. Prepare your written response to the proposals outlined in the paper and submit your response to devicereforms@tga.gov.au  

This consultation will be open until midnight 4 September 2023.  

Why your views matter

This consultation is seeking your feedback on key elements of a proposed application audit framework, including:

  • risk factors informing non-mandatory audit selection
  • criteria for mandatory audits
  • the evidence to be provided with applications to inform audit selection
  • limiting the number of substantial assessment rounds
  • mechanisms to improve visibility of application audit timeframes
  • cost recovery measures for non-mandatory audits.

We also seek feedback about pathways for Class III devices with US FDA 510(k) approval.

We want input from all stakeholders who may be involved in the application audit process. 

What happens next

Submissions will be reviewed by the TGA. A summary of responses will be published and all submissions will be placed on this website (unless marked confidential or indicated otherwise).

Outcomes from the consultation will be provided to the Government for consideration.

Audiences

  • Consumers
  • Health professionals
  • Health workforce
  • General public
  • Industry
  • Sponsors
  • Manufacturers
  • Medical Devices & IVDs

Interests

  • Hospitals
  • Health technology
  • Legislation
  • Health insurance
  • Strategic Policy
  • Policy Development