169 results
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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... MoreCloses 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. ... MoreCloses 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). ... MoreCloses 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... MoreCloses 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... MoreCloses 22 July 2026 -
Application to amend the Poisons Standard (November 2025)
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... MoreCloses 11 July 2025 -
Consultation: Proposed changes to the IVD medical device classifications and definitions
The Therapeutic Goods Administration (TGA) is seeking stakeholders’ feedback on proposed changes to the IVD medical device classifications and definitions. This consultation aims to confirm views on aligning classification rules, principles, and definitions with the European Regulation 2017/746 for in vitro diagnostic medical devices (IVDR) where appropriate. The proposed changes include: • Australian classification rules and principles that classify... MoreCloses 23 May 2025 -
Public consultation on proposed amendments to the Poisons Standard - ACMS & Joint ACMS-ACCS, June 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 June 2025 meeting of the Advisory Committee on Medicines Scheduling (ACMS) and the Joint Meeting of ACMS and the Advisory Committee on Chemicals Scheduling (ACCS) . The closing date for this consultation is close of... MoreCloses 21 May 2025 -
Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS November 2024
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 2024 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Joint meeting of the 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... MoreClosed 4 April 2025 -
Public consultation on interim decision to amend the Poisons Standard in relation to IV potassium
Interim decision Public consultation on the interim decision on scheduling of intravenous potassium (IV potassium) has been resumed i n recognition of the broad impact of the proposed changes and to allow more stakeholders to submit their responses. The closing date for this consultation is close of business 18 March 2025. All submissions received by the deadline will be considered by the delegate before they make a final decision. The interim decision under consultation... MoreClosed 18 March 2025 -
Application to amend the Poisons Standard (June 2025)
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 June 2025... MoreClosed 7 March 2025 -
Public Consultation - TGA fees and charges proposal 2025-26
Consultation: Fees and Charges Proposal 2025-26 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 2025-26 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,... MoreClosed 28 February 2025 -
Review of draft guidance documents - Audit framework for medical devices
The Therapeutic Goods Administration (TGA) is seeking feedback on two new guidance documents developed as part of the new risk-based application audit framework: 1. Draft Guidance - Selection criteria for non-mandatory application audits. This guidance document outlines and clarifies the selection criteria that influence when we select medical device applications for a non-mandatory application audit, including the rationale for the proposed criteria. 2. Draft... MoreClosed 17 February 2025 -
Public consultation on proposed amendments to the Poisons Standard - ACCS & Joint ACMS-ACCS, MARCH 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 MARCH 2025 meeting of the Advisory Committee on Chemicals Scheduling (ACCS) and the joint meeting of the Advisory Committee on Medicines Scheduling (ACMS) and ACCS. The closing date for this consultation is close of... MoreClosed 17 February 2025 -
Adoption of International Scientific Guidelines in Australia R01-2024
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 international... MoreClosed 16 January 2025 -
Review of draft guidance - Complying with the Unique Device Identification regulations for medical devices
The Therapeutic Goods Administration (TGA) is seeking feedback on a new guidance document being drafted for the Australian UDI system: ‘Complying with the Unique Device Identification regulations for medical devices.’ Please note the following: This document will be published in the TGA's new Guidance format as a web page that can be downloaded or printed as a PDF This document does not contain information about UDI implementation dates as these will be published... MoreClosed 15 January 2025 -
Medicine shortages and discontinuations: Proposed changes to reporting requirements
Medicines are essential for the health and wellbeing of Australians. Medicine shortages can occur for various reasons. Unfortunately, some are unavoidable and can cause significant impact. Through our mandatory reporting scheme, the Therapeutic Goods Administration (TGA) receives and publishes reports of shortages and discontinuations of prescription and certain over-the-counter medicines. We work closely with our stakeholders to respond to shortages and limit their impacts. ... MoreClosed 13 January 2025 -
Public consultation on interim decision to amend the Poisons Standard in relation to nicotinic acid and IV potassium
Interim decision This consultation is for an interim decision in relation to nicotinic acid and IV potassium. Once you are familiar with the interim decision, please provide your comments and votes in relation to the interim decision. The closing date for this consultation is close of business 7 January 2024. All submissions received by the deadline will be considered by the delegate before they make an interim decision. The interim decision under consultation are... MoreClosed 7 January 2025 -
Australian Medical Device Essential Principles - Part 2: Proposed alignment with the European Regulation
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... MoreClosed 13 November 2024 -
Application to amend the Poisons Standard (March 2025)
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 2025... MoreClosed 8 November 2024 -
Consultation: Future regulation of assistive technologies
The TGA is seeking feedback on proposed changes to the regulation of assistive technologies. The TGA is Australia's government authority responsible for evaluating, assessing, and monitoring products that are defined as therapeutic goods including medicines, medical devices and biologicals to help Australians stay healthy and safe. T he current provisions in the Therapeutic Goods (Excluded Goods) Determination... MoreClosed 31 October 2024 -
Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, November 2024
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 2024 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) . The closing date for this consultation is close of business 22 October 2024. ... MoreClosed 22 October 2024 -
Clarifying and strengthening the regulation of Artificial Intelligence (AI)
Artificial Intelligence (AI) has already made a difference to many lives, providing the potential to solve problems faster, and opening up opportunities to get things done in smarter and better ways. If safely deployed, its development and adoption can improve wellbeing, quality of life and economic growth. At the same time, caution is needed as AI presents a potential to create or amplify harms to individuals, organisations, communities and social cohesion through risks associated with its... MoreClosed 20 October 2024 -
Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS JUNE, 2024
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 JUNE 2024 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... MoreClosed 18 October 2024 -
Review of draft guidance - Regulatory changes for medical devices containing medicinal substances or materials of animal, microbial or recombinant origin
The Therapeutic Goods Administration (TGA) is seeking feedback on a new guidance document ‘ Regulatory changes for medical devices containing medicinal substances or materials of animal, microbial or recombinant origin – Guidance on the new regulatory requirements and transition arrangements . ’ MoreClosed 9 October 2024 -
Form: Annual Reporting of Custom-made medical devices
Manufacturers and sponsors of custom-made medical devices must supply an annual report to the TGA, detailing all of the custom-made medical devices they have manufactured and/or supplied within the preceding 1 July - 30 June financial year. The report must be submitted by 1 October each year. The report to the TGA can be submitted using this form. Please note: This form is being hosted on a consultation platform, however it is not a consultation and information provided in the form... MoreClosed 1 October 2024 -
Consultation on temporary labelling exemptions for paracetamol
In May of 2023, t he delegate of the Secretary of the Department of Health and Aged Care made a final decision regarding paracetamol pack sizes in the Poisons Standard. Consultation To assist industry in transitioning to new requirements due to the upcoming changes to the scheduling of paracetamol, and to facilitate pharmacy’s ability to supply these products, we are proposing a period of labelling exemptions for signal words for certain... MoreClosed 30 September 2024 -
Proposed changes to the Permissible Ingredients Determination: Low-negligible risk changes 2024-25
The Therapeutic Goods Administration (TGA) is seeking feedback from interested parties on the proposed low-negligible risk changes to the Permissible Ingredients Determination . The proposed changes address the following issues: Herbal ingredients with pregnancy contraindications and other toxic effects Garcinia species, hydroxycitric acid, hydroxycitrate complex and salts, and risk of liver injury Xanthium species ... MoreClosed 13 September 2024 -
Revision of the guidance document TGA Instructions for Disinfectant Testing
The Therapeutic Goods Administration (TGA) is seeking feedback on a revised version of the guidance document ‘TGA Instructions for Disinfectant Testing’. The TGA Instructions for Disinfectant Testing are a regulatory tool, used to provide guidance to sponsors and applicants as to what evidence must be held for their disinfectant/sterilant products to enable inclusion of their products on the Australian Register of Therapeutic Goods (ARTG). The document is used by members of... MoreClosed 30 August 2024 -
Reforming Australia's Therapeutic Goods Testing Regulations
The Therapeutic Goods Administration (TGA) is responsible for protecting the health and safety of the community by regulating therapeutic goods for safety, efficacy, performance, and quality. We do this through the application of the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods Regulations 1990 (the Regulations) and associated legislation. The TGA Laboratories are responsible for delivering results on the quality and performance of therapeutic goods. The testing... MoreClosed 28 August 2024
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