COVID-19 rapid antigen self-tests that are approved in Australia From Therapeutic Goods Administration (TGA) 🇦🇺 A list of approved COVID-19 tests included in the ARTG for supply in Australia. 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 13, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Should your product be in the ARTG From Therapeutic Goods Administration (TGA) 🇦🇺 Check if your product should be on 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 August 7, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Varying entries in the ARTG: medical devices and IVDs From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance is for sponsors applying for a variation to the Australian Register of Therapeutic Goods (ARTG) entry of a medical device or IVD medical device. 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 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Regulatory obligation for exempt medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Exempt therapeutic goods do not need to be included in the ARTG. They do still need to comply with other regulatory requirements. 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Obtain and maintain regulatory evidence From Therapeutic Goods Administration (TGA) 🇦🇺 Understand what evidence is needed to have a medical device included 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 June 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Cancellation of ARTG entry due to non-payment of annual charge From Therapeutic Goods Administration (TGA) 🇦🇺 Cancellation of an Australian Register of Therapeutic Goods (ARTG) entry due to non-payment of annual charge. 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Annual charges From Therapeutic Goods Administration (TGA) 🇦🇺 Information about annual charges for product entries on the Australian Register of Therapeutic Goods (ARTG) and manufacturing licences. 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Conformity assessment procedures for immunohaematology reagents From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance outlines ARTG and conformity assessment procedures for immunohaematology reagents (IHRs) requirements, that manufacturers and sponsors need to know. 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 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Evidence requirements for face masks that are medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 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) 🇦🇺 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) 🇦🇺 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
Overseas regulatory evidence options for a medical device application From Therapeutic Goods Administration (TGA) 🇦🇺 You may be able to use overseas evidence to have your medical device included 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 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Print the ARTG certificate of inclusion for your medical device From Therapeutic Goods Administration (TGA) 🇦🇺 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
Confirm your product is a medical device that needs to be included in the ARTG From Therapeutic Goods Administration (TGA) 🇦🇺 Check if your product is a medical device and if it needs to be included 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 April 23, 2024 Other (Non-Commercial) 0 reuses 0 favorites
DR4 From Therapeutic Goods Administration (TGA) 🇦🇺 Device Requirements version 4 (DR4) provides guidance on transition arrangements for 'retained registered disinfectants' regulated under the pre- 4 October 2002 regulatory framework for medical devices. 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 4, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Application audit (technical file review) of IVD medical device applications From Therapeutic Goods Administration (TGA) 🇦🇺 Prepare for a technical file review as part of your application to include an in vitro medical device in the Australian Register 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 March 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Evaluation of sterilants and disinfectants From Therapeutic Goods Administration (TGA) 🇦🇺 These historical guidelines describe the information to be supplied for the registration or listing of disinfectants and sterilants 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 February 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Including IVD medical devices in the ARTG From Therapeutic Goods Administration (TGA) 🇦🇺 Update to Including IVD medical devices 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 February 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
What 'kind of medical device' is it From Therapeutic Goods Administration (TGA) 🇦🇺 Medical devices, including IVD medical devices, are included in the Australian Register of Therapeutic Goods (ARTG) as a 'kind of medical device'. 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
Medical device inclusion process From Therapeutic Goods Administration (TGA) 🇦🇺 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