13 results
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Public consultation on interim decisions to amend the Poisons Standard - ACMS, ACCS & Joint ACMS-ACCS MARCH, 2024
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 MARCH 2024 meetings of the Advisory Committee on Medicines Scheduling (ACMS) and the Advisory Committee on Chemicals Scheduling (ACCS) and Joint ACMS-ACCS. The closing date for this consultation is close of business 23 AUGUST 2024. All submissions received by the deadline will be considered by... MoreOpened 26 July 2024 -
Revision of the guidance document TGA Instructions for Disinfectant Testing
The Therapeutic Goods Administration (TGA) is seeking feedback on a revised version of the guidance document ‘TGA Instructions for Disinfectant Testing’. The TGA Instructions for Disinfectant Testing are a regulatory tool, used to provide guidance to sponsors and applicants as to what evidence must be held for their disinfectant/sterilant products to enable inclusion of their products on the Australian Register of Therapeutic Goods (ARTG). The document is used by members of... MoreOpened 22 July 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 -
Consultation on the sunsetting Therapeutic Goods Order No.70C - Standards for Export Only Medicine
Therapeutic Goods Order No. TGO 70C (TGO 70C) – Standards for Export Only Medicine ( https://www.legislation.gov.au/F2014L00683/asmade/text ) is a relevant standard for therapeutic goods which are listed for export only in the Australian Register of Therapeutic Goods (ARTG). TGO 70C is due to sunset on 1 October 2024. The Therapeutic Goods Administration (TGA) Export Unit as part of the Prescription Medicines Authorisation Branch (PMAB) is reviewing the sunsetting TGO with the intention... MoreOpened 15 July 2024 -
Consultation on a proposed exposure model for assessing the safety of sunscreen ingredients in Australia
The Therapeutic Goods Administration (TGA) is seeking public comment on proposed models to estimate sunscreen use (exposure) by Australians which will be used to calculate the maximum safe concentration of sunscreen ingredients. The options proposed for stakeholder consideration include: Option 1: Australian Sunscreen Exposure Model (ASEM) The ASEM calculates the highest estimated daily sunscreen exposure, by integrating expected sunscreen... MoreOpened 2 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 -
Reforming Australia's Therapeutic Goods Testing Regulations
The Therapeutic Goods Administration (TGA) is responsible for protecting the health and safety of the community by regulating therapeutic goods for safety, efficacy, performance, and quality. We do this through the application of the Therapeutic Goods Act 1989 (the Act), the Therapeutic Goods Regulations 1990 (the Regulations) and associated legislation. The TGA Laboratories are responsible for delivering results on the quality and performance of therapeutic goods. The testing... MoreOpened 24 June 2024 -
Consultation: Legislating regulatory categories for some boundary and combination products
The Australian Government is undertaking significant reforms to further improve regulation of therapeutic goods in Australia. The Therapeutic Goods Administration (TGA) is the government authority responsible for evaluating, assessing and monitoring products that are defined as therapeutic goods including medicines, medical devices and biologicals. Products that meet the legislative definition of a therapeutic good under the Therapeutic Goods Act 1989 (the Act) are regulated... MoreOpened 24 June 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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