Transition to new manufacturer evidence for IVD medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance is to help sponsors and manufacturers of in vitro diagnostic (IVD) medical devices transition to new manufacturer evidence 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 February 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Recalls and market notifications From Therapeutic Goods Administration (TGA) 🇦🇺 Recalls and market notifications 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 12, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Manufacturer evidence From Therapeutic Goods Administration (TGA) 🇦🇺 Manufacturer evidence 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 12, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Device Change Request (DCR) and variations From Therapeutic Goods Administration (TGA) 🇦🇺 Device Change Request (DCR) and variations 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 12, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Conformity assessment, Essential Principles and consent to supply From Therapeutic Goods Administration (TGA) 🇦🇺 Conformity assessment, Essential Principles and consent to supply 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 12, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Case studies From Therapeutic Goods Administration (TGA) 🇦🇺 These case studies provide practical examples that demonstrate our guidance, legislation and policy in action. 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 29, 2021 Other (Non-Commercial) 0 reuses 0 favorites
TGA workshop recording: SME Assist 'Meeting Your Obligations' - Post-market monitoring From Therapeutic Goods Administration (TGA) 🇦🇺 Covers the general principles of post-market monitoring requirements for therapeutic goods and includes a case study 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 10, 2020 Other (Non-Commercial) 0 reuses 0 favorites
TGA workshop recording: SME Assist 'Meeting Your Obligations' - Advertising From Therapeutic Goods Administration (TGA) 🇦🇺 Covers the general principles of advertising requirements for therapeutic goods and includes two case studies 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 10, 2020 Other (Non-Commercial) 0 reuses 0 favorites
TGA workshop recording: SME Assist 'Meeting Your Obligations' - Manufacturing From Therapeutic Goods Administration (TGA) 🇦🇺 Covers the general principles of manufacturing requirements for therapeutic goods and includes a case study 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 January 16, 2020 Other (Non-Commercial) 0 reuses 0 favorites