Researcher considerations for medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance to assist researchers who are developing new medical devices understand the evidence requirements for market authorisation 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
Use of market authorisation evidence from comparable overseas regulators and assessment bodies for medical devices (including IVDs) From Therapeutic Goods Administration (TGA) 🇦🇺 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
Comparable overseas regulators for medical device applications From Therapeutic Goods Administration (TGA) 🇦🇺 Use of market authorisation evidence from comparable overseas regulators for 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 October 7, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Modification of Market Authorization From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Market Authorization modification procedure 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 December 10, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Brexit /consequences for operators From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Brexit reference document /consequences for the operators in your application process 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 25, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Overview of applying for market authorisation From Therapeutic Goods Administration (TGA) 🇦🇺 Overview of the process to follow if you want to supply therapeutic goods 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 April 29, 2021 Other (Non-Commercial) 0 reuses 0 favorites
TGA workshop recording: SME Assist 'Meeting Your Obligations' - Market authorisation From Therapeutic Goods Administration (TGA) 🇦🇺 Covers the general principles of market authorisation and the process of getting approval to supply a therapeutic good 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
Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Additional Q&A's on use of market authorisation evidence from overseas regulatory bodies 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 August 29, 2019 Other (Non-Commercial) 0 reuses 0 favorites