Open consultations

9 results

  • NOTIFICATION FORM: Clinical decision support software exemption

    This notification form is for Australian manufacturers or sponsors of clinical decision support software, that meet the exemption criteria outlined in the Therapeutic Goods (Medical Devices) Regulations 2002 . The exemption applies to medical devices that are clinical decision support software (CDSS) that meet all three of the following criteria: intended by its manufacturer to be for the sole purpose of providing or supporting a recommendation to a... More
    Closes 25 December 2031
  • Tool: Sponsor obligations for medical devices transitioning from the EU MDD to the EU MDR

    This tool is for sponsors or agents of non-IVD medical devices included in the ARTG with a need to transition from the EU MDD to the new EU MDR to allow medical devices to continue to be supplied in Australia. This tool will assist you to determine what actions you may or may not need to take as a result of changes to conformity assessment documents relevant to your medical devices as a result of the implementation of the European Union Medical Device Regulations (EU MDR). ... More
    Closes 31 July 2029
  • Form: Sponsor notification for medical devices transitioning from the EU MDD to the EU MDR

    Transitioning devices This form is for sponsors or agents of non-IVD medical devices included in the ARTG with a need to transition from the EU MDD to the new EU MDR to allow medical devices to continue to be supplied in Australia. Complete this form if you are a sponsor or agent seeking to utilise TGA’s web publication service to provide market notifications to health care providers and/or end users as a result of your devices transitioning from the EU MDD to the EU MDR. ... More
    Closes 31 July 2029
  • Annual Charge Waiver or Refund for ARTG Entries Subject to Reclassification

    From 1 July 2023, sponsors may apply for an annual charge waiver or refund for eligible transitioning medical devices subject to reclassification. Background In accordance with the Therapeutic Goods Legislation Amendment (2019 Measures No.1) Regulations 2019 , certain categories of medical devices are required to be reclassified so they align, wherever possible with the changes introduced in European Union (EU) medical devices framework. Transitional... More
    Closes 30 June 2029
  • Notification form: Lapses in medical device conformity assessment certification

    Please use this form to notify the TGA of any lapsing or lapsed manufacturer’s conformity assessment certification for your medical device(s). Conformity assessment certification may lapse due to the certification expiring, or if it has been suspended or revoked. Notifying the TGA of any lapse in certification is a legal requirement. Changes to the medical device directive (93/42/EEC) and the IVD Directive (98/79/EC) along with disruptions due to the... More
    Closes 22 July 2026
  • Application to amend the Poisons Standard (November 2024)

    This is the new version of the form: Application to amend the Poisons Standard. Help us improve it by providing your feedback via email to the Scheduling Secretariat . This form contains notes on each page to help you navigate through the sections. You can expand the ‘More information’ tabs for further details. Please note in accordance with the Scheduling committees meeting dates and decisions timeframes published on the TGA website, applications for the November... More
    Closes 12 July 2024
  • Companion diagnostics guidance update- public consultation

    The Therapeutic Goods Administration (TGA) is seeking your feedback on the updated draft Companion Diagnostics (CDx) Guidance document. The proposed updates aim to provide sponsors and manufacturers of medicines, biologicals and IVD medical devices further clarification regarding the requirements for companion testing, including: A CDx testing identification guide to assist them in identifying whether their medicine or biological indication requires companion... More
    Closes 17 June 2024
  • Proposed clarification of how Clinical Decision Support System (CDSS) software is regulated

    The Therapeutic Goods Administration (TGA), as part of the Australian Government Department of Health and Aged Care, regulates therapeutic goods including medicines, medical devices, and biologicals to help Australians stay healthy and safe. Ongoing reforms are undertaken by the TGA to ensure the regulatory oversight of all therapeutic goods remains appropriate. The objective of the reforms is to ensure the sustainability of the Australian regulatory system for therapeutic... More
    Closes 6 May 2024
  • Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS NOVEMBER, 2023

    Interim decisions regarding substances discussed at the expert advisory meetings. This consultation is for interim decisions made in relation to substances that were discussed at the NOVEMBER 2023 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) . The interim decisions published below may differ from the initial proposal. Please read through the proposed interim decisions which can be accessed through... More
    Closes 17 April 2024
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