IMDRF Document Implementation Report From International Medical Device Regulators Forum (IMDRF) 🌍 IMDRF Document Implementation Report 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 1 week ago Other (Public Domain) 0 reuses 0 favorites
Implementation in Italy From Ministry of Health (Italy) (MDS) 🇮🇹 Medical Devices - Implementation in Italy 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 2 weeks ago Creative Commons Attribution 3.0 0 reuses 0 favorites
Direct Final Rule Procedures: Guidance for FDA and Industry From Food and Drug Administration (FDA) 🇺🇸 Guidance document providing procedures for FDA and industry regarding direct final rule implementation. 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Medical devices From European Medicines Agency (EMA) 🇪🇺 Medical devices are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. Metadata quality: Metadata quality: Data description filled 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: 66.66666666666666/100 Updated on May 21, 2024 Other (Public Domain) 0 reuses 0 favorites
Q&A on practical aspects related to the implementation of the extended transitional period provided for in the IVDR, as amended by Regulation (EU) 2024/1860 From European Commission 🇪🇺 Document covers Q&A on practical aspects of implementing extended transitional period in the IVDR, as amended by Regulation (EU) 2024/1860. 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 July 9, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Implementation of medical devices future regime From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 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
Q&A on practical aspects related to the implementation of Regulation (EU) 2023/607 - Extension of the MDR transitional period and removal of the “sell off” periods From European Commission 🇪🇺 Q&A on implementing EU Regulation 2023/607, covering MDR transitional period extension and removal of "sell off" periods. 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 July 10, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Cost Recovery Implementation Statement 2024-2025 From Therapeutic Goods Administration (TGA) 🇦🇺 This Cost Recovery Implementation Statement (CRIS) 2024-2025 provides information on how we implement, and cost recover our regulatory 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 June 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Cost recovery implementation statements From Therapeutic Goods Administration (TGA) 🇦🇺 Current cost recovery implementation statement 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
Guidelines for the implementation of the vigilance system by health care facilities and professionals From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Last updated: 03 June 2019 Guidelines for the implementation of the surveillance system by healthcare facilities and professionals. Ref: AEMPS/CTI-PS/May 2019. How to report incidents. Notification of incidents involving medical devices. How to record the delivery of the product involved in the… 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 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Medical devices: new guidance for industry and notified bodies From European Medicines Agency (EMA) 🇪🇺 A document providing updated guidance for the medical device industry and notified bodies. 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 May 21, 2024 Other (Public Domain) 0 reuses 0 favorites
Consultations and forums From Therapeutic Goods Administration (TGA) 🇦🇺 Public consultation papers covering various aspects of UDI implementation 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 9, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Regulation of devices in Northern Ireland From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Information about the EU Regulations and their implementation in Northern Ireland 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 25, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 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 (“Regulation… 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
Cost Recovery Implementation Statement, 2023-2024 From Therapeutic Goods Administration (TGA) 🇦🇺 This Cost Recovery Implementation Statement provides information on how the TGA, within the Department of Health, implements and cost recovers its regulatory 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 6, 2023 Other (Non-Commercial) 0 reuses 0 favorites
The TGA's approach to delays in medical device conformity assessment recertification From Therapeutic Goods Administration (TGA) 🇦🇺 Our approach to delays in overseas and Australian conformity assessment recertifications due to the COVID-19 pandemic and the implementation of the EU MDR/IVDR. 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 28, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Cost Recovery Implementation Statement, 2022-2023 From Therapeutic Goods Administration (TGA) 🇦🇺 This Cost Recovery Implementation Statement provides information on how the TGA, within the Department of Health, implements and cost recovers its regulatory 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 May 24, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Guidance for Artificial Intelligence and Machine Learning (AI/ML)-Enabled Medical Devices (MDS – G010) From Saudi Food and Drug Authority (SFDA) 🇸🇦 This document provides guidance on AI/ML-enabled medical devices, offering insights for their development and implementation. 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 January 3, 2023 Other (Public Domain) 0 reuses 0 favorites
Corrective Action Implementation Plan form From Saudi Food and Drug Authority (SFDA) 🇸🇦 Form used for documenting and implementing corrective actions. 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 August 3, 2022 Other (Public Domain) 0 reuses 0 favorites
Implementing Regulation of the Law of Medical Devices From Saudi Food and Drug Authority (SFDA) 🇸🇦 Information on regulation implementation for medical devices. 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 27, 2021 Other (Public Domain) 0 reuses 0 favorites