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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 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... 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 -
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... MoreCloses 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,... MoreCloses 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.... MoreCloses 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... MoreCloses 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... MoreCloses 1 October 2026 -
Proposed changes to support automated decision making (ADM) for applications to change listed medicines
Proposed changes to support automated decision making (ADM) for applications to change listed medicines Medicines listed in the Australian Register of Therapeutic Goods (ARTG) under section 26A of the Therapeutic Goods Act 1989 (the Act) are included in the ARTG without pre-market assessment by the Therapeutic Goods Administration (TGA). These medicines are self-listed by the applicant (who becomes the sponsor), or an authorised representative on behalf of a sponsor (such as a... MoreCloses 15 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... MoreCloses 21 August 2026
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