Supply an unapproved therapeutic good (sponsors) From Therapeutic Goods Administration (TGA) 🇦🇺 Find out the requirements to supply unapproved therapeutic goods in Australia, including through the Special Access Scheme or Authorised Prescriber scheme. 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 13, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Process for Handling Referrals to FDA Under 21 CFR 50.54 - Additional Safeguards for Children in Clinical Investigations: Guidance for Clinical Investigators, Institutional Review Boards and Sponsors From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance document titled "Process for Handling Referrals to FDA Under 21 CFR 50.54" that provides additional safeguards for children in clinical investigations. It focuses on Good Clinical Practice (GCP). 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 August 9, 2024 Other (Public Domain) 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
Steps to supply for device sponsors From Therapeutic Goods Administration (TGA) 🇦🇺 A step-by-step process for sponsors (official suppliers) to supply medical devices in, or export them from, Australia. 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 31, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Vapes: information for sponsors, importers and manufacturers From Therapeutic Goods Administration (TGA) 🇦🇺 Learn what the regulatory changes mean for the importation and manufacture of therapeutic vapes. 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Forms (fees and payments) From Therapeutic Goods Administration (TGA) 🇦🇺 The following forms are for the use of sponsors and manufacturers mainly regarding the payment of fees and charges. 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Report an adverse event or problem (industry) From Therapeutic Goods Administration (TGA) 🇦🇺 As the sponsor of a medicine or a medical device in Australia, you have a responsibility to report adverse events. 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 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Exporting a ventilator From Therapeutic Goods Administration (TGA) 🇦🇺 Information for sponsors and manufacturers about pathways for exporting a ventilator from 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 July 10, 2024 Other (Non-Commercial) 0 reuses 0 favorites
IVD sponsors: a roadmap to market From Therapeutic Goods Administration (TGA) 🇦🇺 This road map is intended for Australian sponsors of IVDs and presents an overview of the requirements for supplying an IVD under the new regulatory framework. 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 26, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Clinical performance requirements and risk mitigation strategies for HIV tests From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance for manufacturers and sponsors of HIV tests on meeting regulatory requirements and expectations. 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 24, 2024 Other (Non-Commercial) 0 reuses 0 favorites
CTA scheme forms From Therapeutic Goods Administration (TGA) 🇦🇺 CTA applications are submitted using paper-based forms. There are two forms that must be completed by the sponsor. 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 24, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Understand medical device labelling requirements From Therapeutic Goods Administration (TGA) 🇦🇺 Information for manufacturers and sponsors on meeting medical device labelling requirements. 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
Step 4 Provide and store information - sponsors From Therapeutic Goods Administration (TGA) 🇦🇺 Step 4 Provide and store information 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
Sponsor Vigilance Self-Assessment Tool (SAT) From Therapeutic Goods Administration (TGA) 🇦🇺 The SAT is the first stage of the Medical Devices Vigilance Program Pilot. 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
System or procedure packs From Therapeutic Goods Administration (TGA) 🇦🇺 Information for manufactures and sponsors of medical device systems or procedure packs. 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
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
21 CFR Chapter I Subchapter H – Medical Devices – Part 822 Postmarket Surveillance From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 822 Postmarket Surveillance". Metadata quality: Metadata quality: Data description filled Files documented 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: 77.77777777777779/100 Updated on June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
Custom-made medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Information for manufacturers, sponsors and health professionals on the definition of a custom-made medical device and how we regulate them. 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 31, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Investigator’s brochures for medical device clinical trials From Therapeutic Goods Administration (TGA) 🇦🇺 A sponsor’s guide to the expectations for the contents of an Investigator’s Brochure. 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 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
The Australian UDI Database for sponsors and manufacturers From Therapeutic Goods Administration (TGA) 🇦🇺 Understand what the Australian UDI database is and how to use it. 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 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites