EU MDR Transition web publication service From Therapeutic Goods Administration (TGA) 🇦🇺 The EU MDR Transition web publication service provides notifications to providers and consumers going through low-risk changes, as part of the transition. 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 3 weeks ago 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) 🇦🇺 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
Online assessment tool and online notification form From Therapeutic Goods Administration (TGA) 🇦🇺 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
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
DR4 From Therapeutic Goods Administration (TGA) 🇦🇺 Device Requirements version 4 (DR4) provides guidance on transition arrangements for 'retained registered disinfectants' regulated under the pre- 4 October 2002 regulatory framework 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 April 4, 2024 Other (Non-Commercial) 0 reuses 0 favorites
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
MDR/IVDR Newsletter 2/2023: Extension of the MDR transition period From National Institute of Pharmacy and Nutrition (OGYÉI) ðŸ‡ðŸ‡º A newsletter discussing the extension of the transition period for the Medical Device Regulation (MDR) in the second quarter of 2023. 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 26, 2024 Other (Public Domain) 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
EU MDR transition extension From Therapeutic Goods Administration (TGA) 🇦🇺 We will recognise the extended transition for the European Union Medical Device Regulation (EU MDR). 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 January 9, 2024 Other (Non-Commercial) 0 reuses 0 favorites
How to submit a custom-made medical device and patient-matched medical device notification From Therapeutic Goods Administration (TGA) 🇦🇺 This guide will assist you with completing and submitting a Custom-Made Medical Device (CMMD) notification and Patient-Matched Medical Device (PMMD) transition notification. 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 December 17, 2023 Other (Non-Commercial) 0 reuses 0 favorites
SAHPRA position on EU regulatory transition for medical devices from MDD/AIMDD/IVDD to MDR 2017/745 /IVDR 2017/746 From South African Health Products Regulatory Authority (SAHPRA) 🇿🇦 Document Number MD038 - Version 1 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 on October 2, 2023 Other (Public Domain) 0 reuses 0 favorites
Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency: Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on transitioning medical devices within enforcement policies during the COVID-19 pandemic. 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 March 24, 2023 Other (Public Domain) 0 reuses 0 favorites
Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19): Guidance for Industry, Other Stakeholders, and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for transitioning medical devices with emergency use authorizations related to COVID-19. 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 March 24, 2023 Other (Public Domain) 0 reuses 0 favorites
Therapeutic Goods (Transition to EU Medical Devices Regulation) (Information) Specification 2022 From Office of Parliamentary Council Australia 🇦🇺 Document F2022L01534. 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 January 3, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Transition to the MDR and IVDR - Notified body capacity and availability of medical devices and IVDs From European Commission 🇪🇺 This document discusses the transition to the MDR and IVDR, focusing on notified body capacity and availability of medical devices and IVDs. Metadata quality: Metadata quality: Data description filled 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: 55.55555555555556/100 Updated on September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
MDR Newsletter 26/2021: Frequently asked questions and technical details for the transition to MDR Part V (information accompanying the device and NOR registration of device kits) From National Institute of Pharmacy and Nutrition (OGYÉI) ðŸ‡ðŸ‡º A newsletter discussing frequently asked questions and technical details for transitioning to MDR Part V, focusing on information accompanying device kits and NOR registration. 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 2, 2022 Other (Public Domain) 0 reuses 0 favorites
MDR Newsletter 23/2021: Frequently asked questions and technical details for the transition to MDR - Part IV (Step-by-step registration - Checklist) From National Institute of Pharmacy and Nutrition (OGYÉI) ðŸ‡ðŸ‡º A newsletter discussing frequently asked questions and technical details for transitioning to MDR, focusing on step-by-step registration with a checklist. 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 2, 2022 Other (Public Domain) 0 reuses 0 favorites