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197 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

  • 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

  • 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

  • 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

  • Digital Scribes - Stakeholder Form

    The Therapeutic Goods Administration (TGA) is Australia’s regulatory authority for therapeutic goods and forms part of the Australian Government Department of Health, Disability and Ageing. We are responsible for regulating medical devices, including software as a medical device, in accordance with Australian law. We are reviewing the functionality of digital scribes supplied in Australia to understand their functionality and to consider how the regulatory framework may apply.... More
    Closes 31 December 2026

  • 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 2026)

    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 10 July 2026

  • Improvements to the regulation of sunscreens in Australia

    Seeking feedback on improvements to the regulation of sunscreens in Australia Recent international and domestic developments have highlighted a number of matters in relation to the current regulation of sunscreens. Given Australia has the highest rates of skin cancer and melanoma in the world with around 2,000 people dying each year, it is critical that the regulatory settings are appropriate to ensure consumer confidence in sunscreens. The TGA is seeking feedback... More
    Closes 23 May 2026

  • Personalised medical devices consumer survey

    The Therapeutic Goods Administration (TGA) regulates medical devices to ensure they are safe and work as intended. We regularly review and update our rules to keep pace with technology and protect patients and consumers. We are currently reviewing personalised medical devices. These are devices designed and made to suit you personally. This is often done by taking a scan or a physical impression of a body part, and making the device based on these. Examples of... More
    Closed 24 April 2026

  • Consultation: Conformity Assessment Procedures for Medical Devices | Proposed Amendments

    We are aware of recent proposed changes to the European regulations. Those proposed changes will be considered with the responses to this consultation. The TGA has been systematically reviewing the way medical devices are regulated. This has been guided by An Action Plan for Medical Devices which is a three-part strategy to strengthen Australia’s regulatory system while continuing to be patient focused and have greater transparency. The Australian Government is also... More
    Closed 14 April 2026

  • Application to amend the Poisons Standard (July 2026)

    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 July 2026... More
    Closed 10 April 2026

  • Consultation on proposed changes to labelling of medicines supplied in Australia

    Medicine labels give health professionals and consumers important information to help use medicines safely and correctly. If labels are hard to read or understand, medication errors are more likely. Medicines prescribed or given by a health professional have different risks and need different information on the label compared to medicines chosen off the shelf by a consumer. Because of this, there are two labelling standards in Australia that set out what information must... More
    Closed 23 March 2026

  • Public Consultation - Annual Charge Exemption (ACE) Scheme Compliance Program Updates

    Annual Charge Exemption Scheme The Annual Charge Exemption (ACE) scheme commenced on 1 July 2015. It provides an exemption from paying Therapeutic Goods Administration (TGA) annual charges until a therapeutic good covered by an entry on the Australian Register of Therapeutic Goods (ARTG) begins generating turnover. The scheme allows sponsors to enter their goods in the ARTG in advance of marketing without incurring an annual charge, until the goods are taken to the market. ... More
    Closed 20 March 2026

  • Public Consultation - TGA fees and charges proposal 2026-27

    Consultation: Fees and Charges Proposal 2026-27 The Therapeutic Goods Administration (TGA) is conducting a public consultation to provide industry and other interested stakeholders with an opportunity to comment on the TGA’s proposed fees and charges for the 2026-27 financial year. Specifically, we are seeking feedback on the potential impact/s of the proposed changes to fees and charges prior to seeking approval from the Government for any changes. The TGA,... More
    Closed 27 February 2026

  • Consultation: Improved sharing of information about medical devices | Proposed amendments relating to transparency of disruptions to supply of a medical device

    We want your feedback on the proposed changes to improve transparency about disruptions to the supply of medical devices. The proposed changes are intended to help in monitoring, assessing and responding to potential and actual supply disruptions. These changes align with the intent of An Action Plan for Medical Devices to provide more information to patients about the medical devices they use. What this consultation is about The consultation... More
    Closed 20 February 2026

  • Digital Mental Health Tools User Survey

    The number of people using software, including artificial intelligence (AI), to diagnose, manage and treat mental health conditions is growing. Apps, websites, and computer programs designed for these purposes are referred to as digital mental health tools. The Therapeutic Goods Administration (TGA) is reviewing how these tools are regulated in Australia to make sure these products are safe. More
    Closed 13 February 2026

  • Digital Mental Health Tools Regulatory Environment Survey

    There is growing interest in using software and artificial intelligence (AI) in healthcare delivery, including where it is used to support people with mental health conditions. The Therapeutic Goods Administration (TGA) is reviewing the regulations that apply to software-based medical devices – including digital mental health tools (DMHTs) – that are used to screen, diagnose, monitor and/or treat patients experiencing mental health conditions. We are seeking... More
    Closed 13 February 2026

  • Adoption of International Scientific Guidelines in Australia R01-2025

    The Therapeutic Goods Administration (TGA) is seeking feedback on whether or not certain international scientific guidelines should be adopted. Prior to adopting any international scientific guideline, the TGA undertakes an extensive process of internal and external consultation to ensure the international scientific guideline is consistent with prevailing requirements in Australia. The TGA has approximately 370 current adopted... More
    Closed 10 February 2026

  • UDI Consent to Supply approach and fees

    In March 2025 the Therapeutic Goods (Medical Devices) Regulations 2002 were updated to include Unique Device Identification (UDI) requirements. Mandatory compliance is set to begin on 1 July 2026 for Class III and IIb medical devices, followed by lower device classes over later years . Compliance with UDI requirements is a significant undertaking as it impacts manufacturing processes, quality management systems, IT systems and business processes. The... More
    Closed 30 January 2026

  • Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, MARCH 2026

    Scheduling amendments referred to expert advisory committee This consultation is for applications and delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the MARCH 2026 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) and the Joint meeting of ACMS and ACCS. The closing date for this consultation is... More
    Closed 29 January 2026

  • Public consultation on interim decisions to amend the Poisons Standard - ACCS & Joint ACMS-ACCS - MARCH, 2025

    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 March 2025 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) . Kindly note that the interim decisions published below may differ from the initial proposal. Please read through the proposed interim decisions which can be... More
    Closed 23 January 2026

  • Public consultation on the interim decision to amend the Poisons Standard in relation to adrenaline - ACMS, June 2025

    Interim decision on proposed amendments to the Poisons Standard in relation to adrenaline. This consultation is for an interim decision made in relation to adrenaline that was discussed at the JUNE 2025 meetings of the Advisory Committee on Medicines Scheduling (ACMS) . Kindly note that the interim decision published below may differ from the initial proposal. Please read through the proposed interim decisions which can be accessed through the links below and are available on... More
    Closed 12 January 2026

  • Targeted consultation on proposed changes to the regulation of medicinal maggots

    The Therapeutic Goods Administration (TGA) requests your feedback on proposed regulatory changes to ensure the legislation governing medicinal maggots is fit-for-purpose. Specifically, this consultation seeks feedback on the following proposals: (1) a 2-year transitional licensing exemption from the operation of Part 3-3 of the Therapeutic Goods Act 1989 (the Act) in relation to the manufacture of medicinal maggots (referred to in this paper as the Good Manufacturing... More
    Closed 10 December 2025

  • Proposed GMP exemption for certain bacteriophage manufacture

    The purpose of this consultation is to seek feedback on potential changes to the Therapeutic Goods Regulations 1990 applying to manufacturing of certain bacteriophage therapy products (BTPs) in Australia. Bacteriophages can present a potentially life-saving therapeutic option in the treatment of multidrug-resistant infections. However, it is still considered an experimental therapy and there are no TGA approved BTPs and no Good Manufacturing Practice (GMP) licensed... More
    Closed 13 November 2025

  • Consultation: Provisions to Regularise the Technical Master File (TMFs) and Type II Plasma Master File (PMFs) Processes

    The Therapeutic Goods Administration (TGA) is seeking industry feedback on proposed amendments to strengthen the legislative framework for Technical Master Files (TMFs) for blood and blood components, and Plasma Master Files (PMFs) for Type II plasma-derived products. The proposed changes aim to clarify regulatory requirements, reinforce existing practices, and ensure the legislation reflects the original policy intent. Your input is essential to help ensure the... More
    Closed 11 November 2025

  • Consultation: Product Information as a package insert - consumer administered injectables

    Product Information (PI) as a package insert in non-HCP injectable products The Therapeutic Goods Administration (TGA) is seeking feedback on the current usage of paper information included with injectable medicines. This consultation aims to understand whether the paper copy of the Product Information (PI) document is helpful for patients and carers when it is included in the packaging of injectable medicines that they administer themselves. What is a PI? The Product... More
    Closed 7 November 2025

  • Application to amend the Poisons Standard (March 2026)

    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 March 2026... More
    Closed 7 November 2025

  • Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, NOVEMBER 2025

    Scheduling amendments referred to expert advisory committee This consultation is for applications and delegate initiated proposals to amend the Poisons Standard. The scheduling amendments and any submissions received will be considered at the NOVEMBER 2025 meetings of the Advisory Committee on Medicines Scheduling (ACMS) , the Advisory Committee on Chemicals Scheduling (ACCS) and the Joint Meeting of ACMS and ACCS. The closing date for this consultation is... More
    Closed 17 October 2025

  • Reprocessing and remanufacturing of medical devices

    The TGA is developing guidance documents on the therapeutic goods regulatory requirements for reprocessing and remanufacturing of medical devices. This has been developed in response to queries from two key stakeholder groups: manufacturers and sponsors of reusable and remanufactured medical devices on compliance with regulatory requirements procurement teams, healthcare facilities and healthcare professionals involved in acquiring and using reprocessed and remanufactured... More
    Closed 13 October 2025

  • Consultation: Proposed TGA Annotations to ICH E6(R3) Guideline for Good Clinical Practice (GCP): Principles and Annex I and 12-month Transition Period

    CONSULTATION CLOSED This consultation invites feedback on proposed TGA annotations to ICH E6(R3) Guideline for Good Clinical Practice (GCP): Principles and Annex I and 12-month transition period. On 6 January 2025, the International Council for Harmonisation (ICH) endorsed the third revision (R3) of the ICH Guideline for conducting clinical trials titled ICH E6(R3) Guideline for GCP . This update addresses changes in trial design and technological innovations, and strengthens a... More
    Closed 10 October 2025
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