Therapeutic Goods (Medical DevicesβInformation that Must Accompany Application for Inclusion) Determination 2018 From Office of Parliamentary Council Australia π¦πΊ Document F2018L01410. 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 30, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Therapeutic Goods (Medical DevicesβInformation that Must Accompany Application for Inclusion) Amendment Determination 2024 From Office of Parliamentary Council Australia π¦πΊ Document F2024L00760. 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 25, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Submit your application for inclusion of a medical device From Therapeutic Goods Administration (TGA) π¦πΊ Information about the application process and forms. 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Processing your application for inclusion of a medical device From Therapeutic Goods Administration (TGA) π¦πΊ Possible outcomes of your application and what happens next. 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Evidence requirements for face masks that are medical devices From Therapeutic Goods Administration (TGA) π¦πΊ How to apply for inclusion of face masks (including respirators), that are medical devices, in the Australian Register of Therapeutic Goods (ARTG). 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 May 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 test kits included in the ARTG for legal supply in Australia From Therapeutic Goods Administration (TGA) π¦πΊ View COVID-19 tests approved for inclusion in the Australian Register of Therapeutic Goods (ARTG). 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 May 20, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Applying for TGA assessment of a COVID-19 test for inclusion in the ARTG From Therapeutic Goods Administration (TGA) π¦πΊ Update to information about applying for assessment of a COVID-19 test for inclusion in the ARTG. 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 May 20, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Print the ARTG certificate of inclusion for your medical device From Therapeutic Goods Administration (TGA) π¦πΊ The Australian Register of Therapeutic Goods (ARTG) certificate printing instructions. 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 April 23, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Supporting documentation for inclusion of a medical device From Therapeutic Goods Administration (TGA) π¦πΊ Information on documents that may be required depending on the classification and kind of device (including 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 March 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical device inclusion process From Therapeutic Goods Administration (TGA) π¦πΊ Steps to include a medical device (including IVD medical devices) in the Australian Register of Therapeutic Goods (ARTG). 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 December 21, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Documents to support your medical device inclusion From Therapeutic Goods Administration (TGA) π¦πΊ What you need to submit to include medical devices in the ARTG, including IVDs. 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 November 23, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Use of market authorisation evidence from comparable overseas regulators and assessment bodies for medical devices (including IVDs) From Therapeutic Goods Administration (TGA) π¦πΊ For abridgement of TGA conformity assessments and as information required for applications for ARTG inclusion 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 November 13, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Introduction to Global Medical Device Nomenclature (GMDN) From Therapeutic Goods Administration (TGA) π¦πΊ GMDN guidance is to assist sponsors and manufacturers when applying for inclusion in the ARTG and selecting a GMDN term. 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 September 6, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Auditing of medical device, including IVD medical device, applications From Therapeutic Goods Administration (TGA) π¦πΊ Guidance for sponsors who have submitted applications for inclusion of medical devices including in vitro diagnostics (IVDs), in the Australian Register of Therapeutic Goods (ARTG). 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 12, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Changes to ARTG inclusion process for non-measuring, non-sterile Class I medical devices From Therapeutic Goods Administration (TGA) π¦πΊ Changes to the process for including Class I non-sterile, non-measuring medical devices and Class 1 IVD medical devices in the ARTG 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 April 12, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Application requirements for medical devices - preliminary assessment From Therapeutic Goods Administration (TGA) π¦πΊ Applications for the inclusion of medical devices (including IVDs) in the ARTG must meet certain requirements in order to pass preliminary assessment 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 March 28, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Inclusion of Older Adults in Cancer Clinical Trials: Guidance for Industry From Food and Drug Administration (FDA) πΊπΈ A guidance document for the industry on including older adults in cancer clinical trials, focusing on medical and clinical aspects. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on March 2, 2022 Other (Public Domain) 0 reuses 0 favorites
Therapeutic Goods (Medical Devices - Application Form for Inclusion) Approval (No. 2) 2021 From Therapeutic Goods Administration (TGA) π¦πΊ This instrument is made under subsection 41FDB(2) of the Act. 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 October 1, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Patient Preference Information - Voluntary Submission, Review in Premarket Approval Applications, Humanitarian Device Exemption Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling: Guidance for Industry, Food and Drug Administration Staff, and Other Stakeholders From Food and Drug Administration (FDA) πΊπΈ This is a guidance document titled "Patient Preference Information" that provides instructions for industry and FDA staff on voluntary submissions and reviews in various applications. Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on October 20, 2020 Other (Public Domain) 0 reuses 0 favorites
Use of Symbols in Labeling From Food and Drug Administration (FDA) πΊπΈ Document number 2016-13989. The Food and Drug Administration (FDA or the Agency) is issuing this final rule revising its medical device and certain biological product labeling regulations to explicitly allow for the optional inclusion of graphical representations of information, or symbols, inβ¦ 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 15, 2016 Other (Public Domain) 0 reuses 0 favorites