Medical device reforms: publicly reporting TGA's assessment timeframes From Therapeutic Goods Administration (TGA) 🇦🇺 We publish medical device application processing times twice every year. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated 1 month ago Other (Non-Commercial) 0 reuses 0 favorites
Medical device reforms: Medical Devices Consumer Working Group From Therapeutic Goods Administration (TGA) 🇦🇺 The Medical Devices Consumer Working Group was established in 2019 after the release of TGA’s Action Plan for Medical Devices and a consumer workshop. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated 1 month ago Other (Non-Commercial) 0 reuses 0 favorites
Medical device reforms: improving consumer/patient information From Therapeutic Goods Administration (TGA) 🇦🇺 The TGA publishes consumer-centred information to increase awareness and understanding of devices of public interest or concern. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated 1 month ago Other (Non-Commercial) 0 reuses 0 favorites
Medical device reforms: consumer representation on expert working groups From Therapeutic Goods Administration (TGA) 🇦🇺 The TGA works with subject matter experts in clinical practice and academics in the field on particular devices of concern. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated 1 month ago Other (Non-Commercial) 0 reuses 0 favorites
TGA business plan 2024-25 From Therapeutic Goods Administration (TGA) 🇦🇺 Read our business plan 2024-25 to find out about our strategic priorities and activities. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on August 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
TGA stakeholder survey 2021 From Therapeutic Goods Administration (TGA) 🇦🇺 Results report for the 2021 TGA stakeholder survey. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on August 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
TGA plans and reports From Therapeutic Goods Administration (TGA) 🇦🇺 Browse our corporate business plans, performance frameworks and other corporate reports. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on August 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
TGA actions following 2017 stakeholder survey From Therapeutic Goods Administration (TGA) 🇦🇺 Overview of what we have done in response to comments in the 2017 TGA stakeholder survey. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on August 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical device conformity assessment application From Therapeutic Goods Administration (TGA) 🇦🇺 Information and forms about applications for TGA conformity assessment certificates. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on August 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
TGA reforms From Therapeutic Goods Administration (TGA) 🇦🇺 Information on our regulatory and business process reforms. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on August 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Post-market review of HIV nucleic acid tests From Therapeutic Goods Administration (TGA) 🇦🇺 Find out more about the post-market review the TGA is undertaking on human immunodeficiency virus (HIV) nucleic acid tests (NATs). Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on August 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
News and information From Therapeutic Goods Administration (TGA) 🇦🇺 Find the latest news stories and information on TGA compliance activity. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 12, 2024 Other (Non-Commercial) 0 reuses 0 favorites
List of Ventilators, CPAP, and BiPAP devices containing PE-PUR foam material in the breathing gas pathway From Therapeutic Goods Administration (TGA) 🇦🇺 The TGA has identified additional devices (other than those supplied by Philips Electronics Australia Ltd) that contain PE-PUR foam material for sound abatement purpose in the breathing gas pathway. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure From Therapeutic Goods Administration (TGA) 🇦🇺 How the TGA assesses the safety of materials derived from human and other animal species, naturally susceptible to TSE, that are used in the manufacture of therapeutic goods. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites
TGA structure From Therapeutic Goods Administration (TGA) 🇦🇺 The Therapeutic Goods Administration is part of the Health Products Regulation Group (HPRG) in the Australian Government Department of Health. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on July 4, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Request for certificates or certified copies of TGA licences and certificates From Therapeutic Goods Administration (TGA) 🇦🇺 Use this form to request for certificates or certified copies of TGA licences and certificates Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Compliance undertaking From Therapeutic Goods Administration (TGA) 🇦🇺 A written undertaking is an alternative to court action being commenced by the TGA. Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on July 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Enforceable undertaking guidelines From Therapeutic Goods Administration (TGA) 🇦🇺 Updated guidelines for making an offer of enforceable undertaking to the TGA Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on June 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Determinations for Australian conformity assessment bodies From Therapeutic Goods Administration (TGA) 🇦🇺 These guidelines assist Australian corporations seeking to apply for an Australian conformity assessment body (CAB) determination for medical devices (including IVDs) by the TGA. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 26, 2024 Other (Non-Commercial) 0 reuses 0 favorites
TGA-NATA MoU relating to the regulation of in-house IVDs From Therapeutic Goods Administration (TGA) 🇦🇺 Describers the interaction, role and responsibilities of the TGA and NATA in relation to the regulation of in-house IVDs Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on June 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites