Australian Medical Device Essential Principles - Part 2: Proposed alignment with the European Regulation

Closed 13 Nov 2024

Opened 7 Aug 2024

Contact

Medical Device Reforms Taskforce

devicereforms@tga.gov.au

Overview

UPDATE: Our response to questions asked during the consultation presentation on 11-12 September 2024 has been added to the related documents below the other consultation document links. We have also included a link to the presentation slides.

The Therapeutic Goods Administration (TGA) is the Australian government authority responsible for the regulation of therapeutic goods including medicines, medical devices, and biologicals.

The Australian (AUS) Essential Principles set out the safety and performance characteristics of medical devices in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002

This consultation

This consultation seeks to confirm views, on where appropriate, the AUS Essential Principles should align with the GSPR of the European Regulation 2017/745 on medical devices (MDR) and Regulation 2017/746 for in vitro diagnostic medical devices (IVDR), collectively referred to as the EU Regulations.

There are two documents, the Consultation paper and Attachment 1 available at the bottom of this page. Please read both the documents and keep them available for reference when responding to the survey.

The consultation paper provides:

  • background and other information related to the consultation
  • all of the questions included in the online survey.

Attachment 1 includes:

  • each proposed change for the AUS Essential Principles
  • a legislative comparison between the AUS Essential Principles and the equivalent EU GSPRs.

The Survey

The proposed changes are presented in a questionnaire format for your feedback.

  • Click on the link ‘Consultation questions’ available below to view the ‘Contents’ page.
  • On the ‘Contents’ page there are links to all the proposed changes available. From here, click on the ‘Consent to publish & contact details’ page to respond to questions seeking information about yourself and a mandatory question regarding consent to publish your feedback.
  • After you finish responding to the questions on this page, click on ‘Continue’ button at the bottom of the page to view the ‘Contents’ page.
  • From here, you may select the proposal you wish to review and provide feedback irrespective of the listed order.
  • After you finish responding to questions related to the proposal, click ‘Continue’ button to view the ‘Contents’ page again.

If you are unable to finish the survey at this stage:

  • Click on the ‘Save and come back later’ button available at the end of ‘Contents’ page. You will receive a unique link to your form, with the progress to date, at your nominated email address.
  • To continue the survey, click on the link emailed to you. This link can be shared within the organisation if multiple people wish to provide feedback on the proposed changes. If multiple people are responding to the survey, please make sure the last person responding submits the survey by clicking the ‘Submit response’ button.

To finish the survey:

  • Click on the ‘Finish’ button at the bottom of the ‘Contents’ page to access ‘Almost done…’ page.
  • On this page, click on ‘Submit Response’ button to submit your feedback.

You wont be able to submit your feedback if mandatory question regarding consent to publish your feedback is not answered.

Why your views matter

Your feedback on this consultation will contribute towards strengthening of the regulatory framework for medical devices in Australia by improving the alignment of the AUS Essential Principles with the EU GSPRs.

What happens next

Thank you for your valuable time and input. We will review all submissions and use them to inform policy decisions on amendments to the Therapeutic Goods (Medical Devices) Regulations 2002, including:

  • Schedule 1: Essential Principles for Safety and Performance of medical devices,
  • Regulation 10.2: Sponsor requirements
  • Definitions.

The proposed outcomes will be provided to the Government for consideration. Once a final decision is made, the outcomes will be available in the "We asked, You said, We did" page of the Consultation Hub.

Events

  • Webinar

    From 11 Sep 2024 at 17:00 to 11 Sep 2024 at 18:00

    Webinar will be held to provide an overview of the consultation and opportunity for stakeholders to ask questions on the consultation. Further information on this webinar and a registration link will be circulated via an email shortly.

    Add to my Calendar (.ics)

  • Webinar

    From 12 Sep 2024 at 12:00 to 12 Sep 2024 at 13:00

    Webinar will be held to provide an overview of the consultation and opportunity for stakeholders to ask questions on the consultation. Further information on this webinar and a registration link will be circulated via an email shortly.

    Add to my Calendar (.ics)

Audiences

  • Consumers
  • Non-government organisations
  • State government agencies
  • Commonwealth agencies
  • Health professionals
  • Health workforce
  • General public
  • Community groups
  • Businesses
  • Industry
  • Sponsors
  • Manufacturers
  • Online and Publications staff
  • HPRG (TGA) Staff
  • Medical Devices & IVDs

Interests

  • Hospitals
  • Health technology
  • Legislation
  • Regulatory policy