Overview of language requirements for manufacturers of medical devices From European Commission 🇪🇺 Overview of language requirements for manufacturers of medical devices Metadata quality: Metadata quality: Data description empty Files documentation missing License filled Update frequency not followed File formats are closed Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 44.44444444444444/100 Updated 1 week ago Creative Commons Attribution 4.0 0 reuses 0 favorites
TGA actions following 2017 stakeholder survey From Therapeutic Goods Administration (TGA) 🇦🇺 Overview of what we have done in response to comments in the 2017 TGA stakeholder survey. 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 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Overview From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 An overview of SwissDamed. 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 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Possession and supply of vaping goods in Australia From Therapeutic Goods Administration (TGA) 🇦🇺 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
Overview of medical devices and IVD regulation From Therapeutic Goods Administration (TGA) 🇦🇺 Information to assist you with Australia's regulatory framework for medical devices, including in vitro diagnostic (IVD) 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 July 12, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical devices overview From Therapeutic Goods Administration (TGA) 🇦🇺 Overview of medical devices regulation 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 8, 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
TGA conformity assessment overview for in vitro diagnostic medical devices (IVDs) From Therapeutic Goods Administration (TGA) 🇦🇺 Information on conformity assessment of in vitro diagnostic medical devices (IVDs). 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Overview of the regulatory framework for IVDs From Therapeutic Goods Administration (TGA) 🇦🇺 An overview on Australia's regulatory framework for medical devices, including in vitro diagnostics (IVD) 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
How the TGA regulates From Therapeutic Goods Administration (TGA) 🇦🇺 Overview of how therapeutic goods are regulated 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 June 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Conformity assessment certificate process and timeframes From Therapeutic Goods Administration (TGA) 🇦🇺 An overview for manufacturers applying for a conformity assessment certificate 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 Other (Non-Commercial) 0 reuses 0 favorites
Conformity assessment overview From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance and links to information on conformity assessment 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 June 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
EU MDR Transition From Therapeutic Goods Administration (TGA) 🇦🇺 Overview and management of the EU European Union Medical Devices Regulation (MDR) transition under the Australian 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical masks and respirators: Overview From Health Canada 🇨🇦 Learn about the many different types of masks and respirators and their use. 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 12, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Overview of Unique Device Identification for Australian Healthcare From Therapeutic Goods Administration (TGA) 🇦🇺 This document supports UDI awareness and adoption in Australian healthcare settings 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 15, 2024 Other (Non-Commercial) 0 reuses 0 favorites
EUDAMED – Topics per Actor From European Commission 🇪🇺 This document provides an overview of topics related to EUDAMED system categorized by different actors involved in the process. 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 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
EUDAMED – EUDAMED environments From European Commission 🇪🇺 This document provides an overview of EUDAMED environments, detailing the structure and functionalities of the EUDAMED system 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 March 20, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
EUDAMED – Basic concepts From European Commission 🇪🇺 This document provides an overview of the basic concepts related to EUDAMED, offering insights into its key components and functionalities. 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 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Draft guidance on how to interpret ‘significant change’ of a medical device: Overview From Health Canada 🇨🇦 This guidance document has been updated to expand on the definition of “significant change” in the Medical Devices Regulations (regulations). This will help you determine whether a change proposed to a Class III or IV medical device is significant. 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 7, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guidance on Medical devices for an urgent public health need: Overview From Health Canada 🇨🇦 On January 3, 2024, the Regulations Amending the Medical Devices Regulations (Medical Devices for an Urgent Public Health Need) (regulations) came into force. They are located in Part 1.1 of the Medical Devices Regulations (MDR). This document provides guidance on the regulations in Part 1.1. 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 3, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites