Principle 14: Clinical evidence From Therapeutic Goods Administration (TGA) 🇦🇺 Principle 14 requires every medical device is supported with clinical evidence. The evidence must show the device meets the relevant Essential Principles. 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
Clinical evidence guidelines supplement: In vitro diagnostic (IVD) medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance has been developed to help manufacturers understand how the TGA interprets regulations and how manufacturers can comply with them 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 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Clinical evidence guidelines From Therapeutic Goods Administration (TGA) 🇦🇺 These guidelines provide details and guidance on the clinical evidence requirements for medical devices, including In Vitro Diagnostic medical devices (IVDs), under Australian legislation. 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 23, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Guidance on clinical evidence requirements for medical devices: Overview From Health Canada 🇨🇦 This document provides guidance to manufacturers of Class III and IV medical devices and regulatory representatives on the clinical evidence requirements 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 17, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Presentation: Medical device regulatory lifecycle and clinical evidence requirements From Therapeutic Goods Administration (TGA) 🇦🇺 TGA presentation slides from Queensland Cardiovascular Research Network Webinar (25 June 2021). 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 20, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Guidance on general principles of clinical evidence for In Vitro Diagnostic medical devices (IVDs) From European Commission 🇪🇺 This document provides guidance on clinical evidence for 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 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
GHTF Study Group 5 - Clinical Safety/Performance From International Medical Device Regulators Forum (IMDRF) 🌍 GHTF Study Group 5 - Clinical Safety/Performance documents Metadata quality: Metadata quality: Data description empty Files documented 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 November 2, 2012 Other (Public Domain) 0 reuses 0 favorites
Clinical evidence guidelines documents for medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Clinical evidence guidelines: Medical devices have been finalised and are now available 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 October 12, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Guidance on sufficient clinical evidence for legacy devices From European Commission 🇪🇺 This document provides guidance on obtaining sufficient clinical evidence for legacy devices, focusing on clinical investigation and evaluation. 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
Guide No. 29 version 1 of 17/12/2019 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Medical Devices Clinical Evidence Guide - Concepts and Definitions Metadata quality: Metadata quality: Data description empty Files documented 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 30, 2019 Other (Public Domain) 0 reuses 0 favorites
Clinical Evidence - Key Definitions and Concepts From International Medical Device Regulators Forum (IMDRF) 🌍 Technical document: IMDRF MDCE WG/N55FINAL:2019 (formerly GHTF/SG5/N1R8:2007) Metadata quality: Metadata quality: Data description empty Files documented 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 October 10, 2019 Other (Public Domain) 0 reuses 0 favorites
Clinical evaluation of medical devices / Performance evaluation and clinical evidence of in-vitro medical devices From National Authority of Medicines and Health Products (Infarmed) 🇵🇹 Entities menu, medical devices area, access to the area of clinical evaluation of medical devices (DM) / evaluation of the functional behavior of diagnostic devices in vitro (DIV) 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 November 30, 2023 Other (Public Domain) 0 reuses 0 favorites