5 results
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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... MoreCloses 6 May 2024 -
Public consultation on proposed amendments to the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS, JUNE 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 JUNE 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 MAY 2024. ... MoreCloses 22 May 2024 -
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... MoreCloses 28 May 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 ... MoreCloses 9 June 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... MoreCloses 17 June 2024
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