Technical Reference Group for Software as a Medical Device (SaMD) and Artificial Intelligence (AI) From Therapeutic Goods Administration (TGA) 🇦🇺 Information on the role and membership of the Technical Reference Group for SaMD and AI. 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 15, 2024 Other (Non-Commercial) 0 reuses 0 favorites
TGA-NATA MoU relating to the regulation of in-house IVDs From Therapeutic Goods Administration (TGA) 🇦🇺 Describers the interaction, role and responsibilities of the TGA and NATA in relation to the regulation of in-house IVDs 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
Proposal for a COUNCIL DECISION on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning an amendment to Annex II (Technical regulations, standards, testing and certification) and Protocol 37 (containing the list provided for in Article 101) to the EEA Agreement (Reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices) From European Parliament 🇪🇺 A proposal for a decision within the European Union regarding an amendment to technical regulations and protocols in the EEA Agreement for enhanced crisis management in medicinal products and 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 11, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Economic operators From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇠Learn about economic operators and their role in reporting incidents and FSCAs (vigilance). 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 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Roles and responsibilities for clinical trial safety reporting of significant safety issues and urgent safety measures From Therapeutic Goods Administration (TGA) 🇦🇺 Summarises the roles and responsibilities of key stakeholders in clinical trial safety reporting of significant safety issues (SSIs) and urgent safety measures (USMs). 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 9, 2024 Other (Non-Commercial) 0 reuses 0 favorites
The role of the TGA From Therapeutic Goods Administration (TGA) 🇦🇺 You have probably learned a bit about the TGA through your professional practice, but there are aspects of our work that you may not be aware of. 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 21, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Quality management system audits and certification guidance From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance for medical devices manufacturers on how we conduct Quality Management System (QMS) audits, roles and responsibilities for audits, aspects of conformity assessment certification and post-audit activities. 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 19, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Guidance on article 15 of the medical device regulation (MDR) and in vitro diagnostic device regulation (IVDR) on a ‘person responsible for regulatory compliance’ (PRRC) From European Commission 🇪🇺 This document provides guidance on the role of a 'person responsible for regulatory compliance' in medical device and in vitro diagnostic device regulations. 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 December 20, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
A new role for EMA in monitoring and mitigating critical medical device shortages during public health emergencies From European Medicines Agency (EMA) 🇪🇺 EMA takes on new role in managing medical device shortages during public health crises. 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 2, 2023 Other (Public Domain) 0 reuses 0 favorites
Technical health committee - Section for the issuance of licenses for healthcare advertising From Ministry of Health (Italy) (MDS) 🇮🇹 This document discusses the Technical Health Committee's role in issuing licenses for healthcare advertising and promotional activities. 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 17, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Medical device shortages: Overview From Health Canada 🇨🇦 Medical devices shortages occur when supply cannot meet current demand and when anticipated future supply cannot meet projected demand. Explains who needs to report, when it needs to be reportsed what happens next, and roles in responding. 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 15, 2022 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices From European Commission 🇪🇺 Regulation (EU) 2022/123 on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and 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 January 25, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
Reporting adverse events From Therapeutic Goods Administration (TGA) 🇦🇺 Everyone can play an important role in monitoring the safety of therapeutic goods 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 19, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Explanatory note on IVDR codes From European Commission 🇪🇺 Explanatory note on IVDR codes, focusing on the role of notified bodies. 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 September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
MDR Newsletter 3/2020: Person Responsible for Regulatory Compliance (PRRC) From National Institute of Pharmacy and Nutrition (OGYÉI) ðŸ‡ðŸ‡º A newsletter discussing the role of Person Responsible for Regulatory Compliance (PRRC) in the context of Medical Device Regulation (MDR) in 2020. 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 17, 2021 Other (Public Domain) 0 reuses 0 favorites
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL on a reinforced role for the European Medicines Agency in crisis preparedness and management for medicinal products and medical devices From European Parliament 🇪🇺 A proposal for a regulation to enhance the role of the European Medicines Agency in crisis preparedness and management for medicinal products and 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 November 11, 2020 Creative Commons Attribution 4.0 0 reuses 0 favorites
TGA workshop recording: SME Assist 'Meeting Your Obligations' - Basics of therapeutic goods regulation From Therapeutic Goods Administration (TGA) 🇦🇺 Provides an overview of therapeutic goods regulation, TGA's role and sponsor responsibilities when supplying therapeutic goods 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 January 16, 2020 Other (Non-Commercial) 0 reuses 0 favorites
Conformity assessment bodies From National Institute of Pharmacy and Nutrition (OGYÉI) ðŸ‡ðŸ‡º A document outlining the roles and responsibilities of conformity assessment bodies. Includes links to lists of organizations designated to certify 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 5, 2019 Other (Public Domain) 0 reuses 0 favorites
Explanatory note on MDR codes From European Commission 🇪🇺 Explanatory note on MDR codes, focusing on the role of notified bodies. 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 September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Video: Invoicing and the role of the Clinical Trials Repository From Therapeutic Goods Administration (TGA) 🇦🇺 Watch this video to learn about invoicing, variations to CTNs and the Clinical Trial Repository. 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 March 20, 2018 Other (Non-Commercial) 0 reuses 0 favorites