Wholesalers & manufacturers guidance following agreement of the Windsor Framework From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง Actions QPs, RPis and RPs need to take following agreement of the Windsor Framework 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 1 week ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
TGA plans and reports From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Browse our corporate business plans, performance frameworks and other corporate reports. 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 of medical devices and IVD regulation From Therapeutic Goods Administration (TGA) ๐ฆ๐บ 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
Implementation of medical devices future regime From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง A roadmap outlining the intended timelines for delivering a future regulatory framework for medical devices and an intended policy on international recognition. 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 3, 2024 Open Government Licence 2.0 (United Kingdom) 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
Proposal for a COUNCIL DECISION on the signing, on behalf of the European Union, of the Council of Europe Framework Convention on Artificial Intelligence, Human Rights, Democracy and the Rule of Law From European Parliament ๐ช๐บ A proposal for the European Union to sign the Council of Europe Framework Convention on Artificial Intelligence, focusing on human rights, democracy, and the rule of law. 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 June 26, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Submissions received: Changes to a number of definitions and the scope of the medical device regulatory framework in Australia From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The TGA thanks respondents who provided a submission in response to the public consultation paper 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) ๐ฆ๐บ 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
Legal framework From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Information on advertising legislation and how we manage advertising compliance. 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
EU MDR Transition From Therapeutic Goods Administration (TGA) ๐ฆ๐บ 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
Australiaโs breast implant risk management framework From Therapeutic Goods Administration (TGA) ๐ฆ๐บ This framework outlines our processes to identify and manage risk relating to breast implants. 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 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
DR4 From Therapeutic Goods Administration (TGA) ๐ฆ๐บ 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
EUDAMED โ Modules objective From European Commission ๐ช๐บ This document outlines the objectives and functions of various modules within the EUDAMED system, providing insights into its operational 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 April 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
EUDAMED โ Colour scheme and layout From European Commission ๐ช๐บ This document outlines the color scheme and layout guidelines for EUDAMED, providing a visual framework for the system's design and user interface. 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
The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง These Regulations make provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (โRegulationโฆ 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 22, 2024 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
Medical Devices; Quality System Regulation Amendments From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2024-01709. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. We are harmonizing to alignโฆ 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 2, 2024 Other (Public Domain) 0 reuses 0 favorites
Refinements to the Personalised Medical Device Framework From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Guidance to assist sponsors and manufacturers comply with new regulations. 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 17, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Personalised medical devices (including 3D-printed devices) From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Information and examples to help you understand the regulatory framework for personalised 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 December 15, 2023 Other (Non-Commercial) 0 reuses 0 favorites
European medical device regulations From Ministry of Health (Italy) (MDS) ๐ฎ๐น Medical device sector is of great importance in healthcare in Europe, contributing to the improvement of the level of health protection through the development of innovative solutions for diagnosis, prevention, treatment and rehabilitation. Since the early 2020s, due to the SARS-CoV-2 pandemic,โฆ 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 12, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Review of the Therapeutic Goods Advertising Framework From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Final Report on the impact of advertising reforms from the Expert Panel Review of Medicines and Medical Devices Regulation, and other initiatives 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 8, 2023 Other (Non-Commercial) 0 reuses 0 favorites