Medical devices reforms: software regulation From Therapeutic Goods Administration (TGA) 🇦🇺 New classifications clarify regulation of software-based medical devices. 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
Regulation of software based medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Software based medical devices are medical devices that incorporate software or are software. 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 26, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Regulatory changes for software based medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance provides a summary of changes to the regulation of software based medical devices (including software as a 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 July 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Re-classification of software based medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Changes to the regulation for software based medical devices may have impacted some sponsors and manufacturers. 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, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Medical device cyber security information for users From Therapeutic Goods Administration (TGA) 🇦🇺 Find out how to use electronic or software-based medical devices safely. 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 24, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Software-based medical devices FAQs From Therapeutic Goods Administration (TGA) 🇦🇺 Frequently asked questions regarding the regulatory approach of the TGA for software based 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 December 9, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Classification of active medical devices (including software-based medical devices) From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance to help manufacturers of active medical devices, including software-based medical devices, to classify their 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 October 11, 2021 Other (Non-Commercial) 0 reuses 0 favorites
How the TGA regulates software based medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance summarises the regulatory approach of the TGA for software based medical devices 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 24, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Submissions received: Scope of regulated software based medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Report on feedback to recent public consultation on the scope of regulated software products 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 17, 2020 Other (Non-Commercial) 0 reuses 0 favorites