CPG Sec. 160.100 Regulatory Actions and Small Business From Food and Drug Administration (FDA) 🇺🇸 CPG Sec. 160.100 provides guidance on regulatory actions and their impact on small businesses. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated 2 weeks ago Other (Public Domain) 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
Impact of new European regulations on software classification From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document Impact of new European regulations on the classification of software in your application 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 July 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices From Therapeutic Goods Administration (TGA) 🇦🇺 Regulation Impact Statement in support of proposed reforms around personalised 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Regulation impact statements for medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 A list of TGA Regulation impact statements that relate to 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Impact of AI on the regulation of medical products From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Implementing the Artificial Intelligence (AI) White Paper principles. 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 30, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes From International Medical Device Regulators Forum (IMDRF) 🌍 Technical document: IMDRF/AE WG/N43FINAL:2020 (Edition 4) - Annexes and release notes updated annually Current release: IMDRF/AE WG/N43FINAL:2024 Updated Annexes 20 April 2024; Annex A_1 – updated 9 May 2024 (refer release notes for details) 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 on March 7, 2024 Other (Public Domain) 0 reuses 0 favorites
Reporting system for in vitro diagnostic medical devices From Ministry of Health (Italy) (MDS) 🇮🇹 The Ministry of Health carries out the activities of monitoring and investigating reports from healthcare professionals and manufacturers. On Sept. 28, 2022, Legislative Decree No. 138 of Aug. 5, 2022 , came into force, which in Article 13 provides fulfillments for manufacturers of in vitro… 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, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Review of the Therapeutic Goods Advertising Framework From Therapeutic Goods Administration (TGA) 🇦🇺 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
Re-classification of software based medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Changes to the regulation for software based medical devices may have impacted some sponsors and manufacturers. 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 12, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Policy for Evaluating Impact of Viral Mutations on COVID-19 Tests (Revised): Guidance for Test Developers and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 Revised policy providing guidance for evaluating impact of viral mutations on COVID-19 tests, aimed at test developers and FDA staff. 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
Responding to emerging COVID-19 variants of concern From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 A set of principles for understanding the impact of new variants on antiviral drugs and monoclonal antibodies 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, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
FDA and Industry Actions on Premarket Approval Applications (PMAs): Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for the FDA and industry on the impact of premarket approval applications on review timelines and goals. 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 October 6, 2022 Other (Public Domain) 0 reuses 0 favorites
FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on FDA and industry actions regarding De Novo classification requests and their impact on review timelines and goals. 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 October 3, 2022 Other (Public Domain) 0 reuses 0 favorites
MDR Newsletter 1/2021: The impact of BREXIT on the distribution of medical devices From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter discussing the impact of BREXIT on the distribution of medical devices in the first issue of 2021. 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
Notice to manufacturers and authorised representatives on the impact of genetic variants on SARS-COV-2 in vitro diagnostic medical devices From European Commission 🇪🇺 Notice to manufacturers and authorised representatives on the impact of genetic variants on COVID-19 diagnostic devices. 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
Independent review of the reforms to the therapeutic goods advertising framework to commence From Therapeutic Goods Administration (TGA) 🇦🇺 An independent review of the impact of the reforms to the therapeutic goods advertising framework has commenced. 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 10, 2020 Other (Non-Commercial) 0 reuses 0 favorites
Impact of Certain Provisions of the Revised Common Rule on FDA-Regulated Clinical Investigations: Guidance for Sponsors, Investigators, and Institutional Review Boards From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on the impact of certain provisions of the Revised Common Rule on FDA-regulated clinical investigations. 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 July 18, 2019 Other (Public Domain) 0 reuses 0 favorites