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215 results

  • Form: Confirmation of M2M HL7 SPL testing completion

    This form is for medical device sponsors, manufacturers, or agents. It lets you advise the Therapeutic Goods Administration (TGA) that you confirm that your organisation has completed M2M HL7 SPL testing in accordance with the validation procedure in the M2M HL7 SPL – User Guide – AusUDID and is ready to submit UDI records to the AusUDID Production environment, using HL7 SPL. In particular, the confirmation is designed to reflect that you have undertaken all necessary... More
    Closes 1 January 2100

  • Form: Intent to submit to AusUDID using M2M HL7 SPL

    This form is for medical device sponsors, manufacturers, agents or third party data providers. It lets you advise the Therapeutic Goods Administration (TGA) that you plan to submit data to the Australian Unique Device Identification Database (AusUDID) using the M2M HL7 SPL submission method. Important information: You cannot submit data to the AusUDID using M2M HL7 SPL until this form is completed. For more information on using the M2M... More
    Closes 1 January 2100

  • 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 31 July 2035

  • 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

  • Report a potential medical device disruption or shortage

    When to use this form Use this form to report a potential medical device supply disruption or shortage to the Therapeutic Goods Administration (TGA). a shortage of a raw material a shortage of a component a natural disaster/incident interrupts production a manufacturing site issue (e.g. quality control or certification) a transportation/shipping issue or delay an unexpected surge in demand a product is discontinued. Advice about medical... More
    Closes 30 June 2027

  • Section 41HD Application Form

    About section 41HD Section 41HD of the Therapeutic Goods Act 1989 (the Act) allows approval to be given for sponsors to supply and/or import medical devices: for a specified timeframe, when there is a disruption or shortage (or will be in the reasonably foreseeable future) of a device included in the Australian Register of Therapeutic Goods (ARTG), and/or it is in the interests of public health (for example,... More
    Closes 30 June 2027

  • 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

  • Application to amend the Poisons Standard (March 2027)

    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 2027... More
    Closes 6 November 2026

  • 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... More
    Closes 1 October 2026

  • Adoption of International Scientific Guidelines in Australia R01-2026

    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... More
    Closes 11 September 2026

  • Proposed changes to Required Advisory Statements for Medicine Labels (RASML)

    The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on proposed changes to the Required Advisory Statements for Medicine Labels (RASML) . RASML sets out advisory statements that are required to be included on the labels of specified OTC and registered complementary medicines. The proposed changes to RASML are: addition of entries for three new substances not currently included in RASML - celecoxib, methenamine and naratriptan ... More
    Closes 4 September 2026

  • Improvements to the Therapeutic Goods Advertising Code

    The Therapeutic Goods Administration (TGA) within the Department of Health, Disability and Ageing is seeking feedback on options and proposed changes to improve the Therapeutic Goods (Therapeutic Goods Advertising Code) Instrument 2021 (the Code). We are reviewing parts of the Code to make sure it: is clear and easy to apply reflects current advertising practices supports safe and appropriate use of therapeutic goods. ... More
    Closes 3 September 2026

  • Radiopharmaceutical regulation in Australia - Open public consultation

    The Therapeutic Goods Administration (TGA) is seeking high‑level stakeholder feedback on how current regulatory settings for radiopharmaceuticals operate in practice. This consultation is intended to support informed consideration of stakeholder experiences with existing regulatory pathways, exemptions and access mechanisms. Feedback received will be used to inform future targeted consultation and engagement activities. To support stakeholder feedback, the TGA has... More
    Closes 21 August 2026

  • ODC Medicinal Cannabis Permit Holder Supply Pathways 2026

    The Office of Drug Control (ODC) is seeking feedback from permit holders under the Narcotic Drugs Act 1967 on supply pathways used by industry participants. Your feedback will help the ODC better understand current industry practices and identify opportunities to develop practical guidance and support for licence holders. More
    Closes 16 August 2026

  • Proposed changes to the Permissible Indications Determination

    Proposed changes to the Permissible Indications Determination Listed medicines are considered low-risk medicines as they can only use low-risk ingredients and make low-level indications. These medicines are not individually evaluated by the Therapeutic Goods Administration (TGA) before they are released onto the market. Instead, they are automatically included in the Australian Register of Therapeutic Goods (ARTG) following completion of an online application and certification by the... More
    Closes today

  • Digital mental health tools: Service provider survey

    The Therapeutic Goods Administration (TGA) is reviewing the regulations that apply to digital mental health tools (DMHTs). DMHTs are software products including apps, websites, or platforms, that offer assessments, therapy, or self-management strategies to support mental health care. We are seeking information on software and DMHTs in use by digital mental health service providers accredited to the National Safety and Quality Digital Mental Health Standards. A better... More
    Closed 7 August 2026

  • Public consultation on interim decision to amend the Poisons Standard in relation to psilocybine - ACMS JUNE 2025

    Interim decisions regarding substances discussed at the expert advisory meetings. This consultation is for the interim decision made in relation to psilocybine that was discussed at the June 2025 meeting 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 decision which can be accessed through the link below and is available on the... More
    Closed 31 July 2026

  • Increasing transparency of Good Manufacturing Practice (GMP) inspection outcomes

    The Therapeutic Goods Administration (TGA) is seeking feedback on a proposal to publish information about Good Manufacturing Practice (GMP) compliance on the TGA website. The purpose of publishing this information is to: improve transparency of regulatory oversight of the manufacture of pharmaceutical products supplied in Australia; help the public better understand the safeguards in place to ensure quality of pharmaceutical products; and ... More
    Closed 13 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
    Closed 10 July 2026

  • Public consultation on interim decisions to amend the Poisons Standard - ACMS & Joint ACMS-ACCS JUNE, 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 JUNE 2025 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the ACMS and the Advisory Committee on Chemicals Scheduling (ACCS) in joint session. Kindly note that the interim decisions published below may differ from the initial proposal. Please read through the... More
    Closed 10 July 2026

  • Public consultation on proposed amendments to the Poisons Standard - ACMS & Joint ACMS-ACCS - JULY 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 JULY 2026 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Joint Meeting of Advisory Committee on Chemicals Scheduling (ACCS) and ACMS. The closing date for this consultation is close of... More
    Closed 30 June 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
    Closed 23 May 2026

  • Targeted consultation - AP scheme for psychedelics

    This publication sets out the final recommendations from the targeted consultation and subsequent stakeholder engagements on access to 3, 4-methylenedioxy-methamphetamine (MDMA) and psilocybine under the Authorised Prescriber (AP) scheme. On 1 July 2023, the Poisons Standard was amended to allow access to MDMA for the treatment of post-traumatic stress disorder and psilocybine for treatment-resistant depression by psychiatrists who are specifically authorised under the... More
    Closed 19 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
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