11 results
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Review of draft guidance - Regulatory changes for medical devices containing medicinal substances or materials of animal, microbial or recombinant origin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 . ’ MoreOpened 28 August 2024 -
Australian Medical Device Essential Principles - Part 2: Proposed alignment with the European Regulation
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 the safety and performance characteristics of medical devices in Schedule 1 of the Therapeutic Goods (Medical Devices) Regulations 2002 This consultation This consultation seeks to confirm views, on where appropriate,... MoreOpened 7 August 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... MoreOpened 6 August 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 ... MoreOpened 2 August 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... MoreOpened 22 July 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... MoreOpened 1 July 2024 -
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... MoreOpened 1 July 2023 -
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. ... MoreOpened 1 December 2022 -
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). ... MoreOpened 1 December 2022 -
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... MoreOpened 3 October 2022 -
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... MoreOpened 4 January 2021
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