21 CFR Chapter I Subchapter H โ Medical Devices โ Part 864 Hematology and Pathology Devices From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 864 Hematology and Pathology Devices". 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Supply an unapproved therapeutic good (sponsors) From Therapeutic Goods Administration (TGA) ๐ฆ๐บ 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
COVID-19 rapid antigen self-tests that are approved in Australia From Therapeutic Goods Administration (TGA) ๐ฆ๐บ 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
Principle 2: Design and construction of medical devices to conform with safety principles From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Manufacturers of medical devices must hold evidence that demonstrates that their devices meet the Principles before their devices can be supplied in 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 August 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
How we are managing medical device supply disruptions resulting from changes in Europe From Therapeutic Goods Administration (TGA) ๐ฆ๐บ We are managing the impact of the European Union Medical Devices Regulation (EU MDR) transition in 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 August 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Steps to supply for device sponsors From Therapeutic Goods Administration (TGA) ๐ฆ๐บ 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
Steps to supply for device manufacturers From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Step-by-step process for manufacturers to supply devices in, or export them 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 31, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Vapes: information for wholesale, transport, logistics and storage facilities From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Learn what the regulatory changes mean for the supply and commercial possession of therapeutic vapes. 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Possession and supply of vaping goods in Australia From Therapeutic Goods Administration (TGA) ๐ฆ๐บ This guidance provides an overview of who may possess (and in some instances, also supply) specified vapes, under the Possession and Supply Determination. 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 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Supply a biological From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Find information on the supply of biologicals. 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 16, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Legal supply of COVID-19 test kits From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Updated information about the legal supply of COVID-19 test kits 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 16, 2024 Other (Non-Commercial) 0 reuses 0 favorites
List of Ventilators, CPAP, and BiPAP devices containing PE-PUR foam material in the breathing gas pathway From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The TGA has identified additional devices (other than those supplied by Philips Electronics Australia Ltd) that contain PE-PUR foam material for sound abatement purpose in the breathing gas pathway. 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
Supply a medical device From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Guidance on legally supplying medical devices in, and exporting them 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
What classification is my medical device? From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Use this decision tree to work out the classification of the medical device you want to sell or supply in 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 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
IVD sponsors: a roadmap to market From Therapeutic Goods Administration (TGA) ๐ฆ๐บ 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
The use of GMDN codes for IVD medical devices in Australia From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The use Global Medical Device Nomenclature (GMDN) codes for in vitro diagnostic medical devices supplied in 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 June 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical device supply disruptions From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Find out how to manage a medical device supply disruption or shortage. 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
Is my product a therapeutic good? From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Use this decision tree to work out if the product you want to sell or supply in Australia is 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 June 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Online assessment tool and online notification form From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Use our online assessment tool and notification form to transition to the new EU MDR, so you can continue supplying 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 June 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Therapeutic Goods (Medical DevicesโAuthorised Supply) Rules 2022 From Office of Parliamentary Council Australia ๐ฆ๐บ Document F2022L01711. 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 19, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites