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Instructions For Use for Medical Devices
The Therapeutic Goods Administration (TGA) is the Australian government authority responsible for the regulation of therapeutic goods including medicines, medical devices, and biologicals to help Australians stay healthy and safe. The Therapeutic Goods Act 1989 and associated supporting legislation set out the regulatory requirements for medical devices. This includes the information to be provided with a medical device through product label and Instructions for Use (IFU) and the... MoreOpened 15 April 2024 -
Proposed changes to the regulation of exempt medical devices and exempt Other Therapeutic Goods
The TGA is Australia's government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods. The TGA regulates therapeutic goods including medicines, medical devices and biologicals to help Australians stay healthy and safe. Products that meet the legislative definition of a therapeutic good under the Therapeutic Goods Act 1989 (the Act) are regulated by the TGA and generally need to seek pre-market approval and be included in the ... MoreOpened 15 April 2024 -
Companion diagnostics guidance update- public consultation
The Therapeutic Goods Administration (TGA) is seeking your feedback on the updated draft Companion Diagnostics (CDx) Guidance document. The proposed updates aim to provide sponsors and manufacturers of medicines, biologicals and IVD medical devices further clarification regarding the requirements for companion testing, including: A CDx testing identification guide to assist them in identifying whether their medicine or biological indication requires companion... MoreOpened 15 March 2024 -
Proposed clarification of how Clinical Decision Support System (CDSS) software is regulated
The Therapeutic Goods Administration (TGA), as part of the Australian Government Department of Health and Aged Care, regulates therapeutic goods including medicines, medical devices, and biologicals to help Australians stay healthy and safe. Ongoing reforms are undertaken by the TGA to ensure the regulatory oversight of all therapeutic goods remains appropriate. The objective of the reforms is to ensure the sustainability of the Australian regulatory system for therapeutic... MoreOpened 12 March 2024 -
Application to amend the Poisons Standard (November 2024)
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... MoreOpened 4 March 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 -
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 -
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 -
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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