Information session on the pilot for expert panels' advice for orphan medical devices From European Medicines Agency (EMA) 🇪🇺 An upcoming event discussing a pilot program for expert panels' advice on orphan medical devices. 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 2 days ago Other (Public Domain) 0 reuses 0 favorites
The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Labs, 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 August 9, 2024 Other (Public Domain) 0 reuses 0 favorites
New pilot programme to support orphan medical devices From European Medicines Agency (EMA) 🇪🇺 Announcement of a new pilot programme aimed at providing support for orphan 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 August 2, 2024 Other (Public Domain) 0 reuses 0 favorites
Sponsor Vigilance Self-Assessment Tool (SAT) From Therapeutic Goods Administration (TGA) 🇦🇺 The SAT is the first stage of the Medical Devices Vigilance Program Pilot. 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
National register of breast prosthetic implants From Ministry of Health (Italy) (MDS) 🇮🇹 Breast implants , commonly implanted for cosmetic or reconstructive reasons, are class III medical devices, the highest risk class, regulated by Legislative Decree No. 137 of August 5, 2022 and EU Regulation 745/2017 . The Ministry of Health, as the Competent Authority on medical devices in Italy,… 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 5, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
The Innovative Devices Access Pathway (IDAP) From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market. 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 29, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Medical Devices Vigilance Program - Pilot From Therapeutic Goods Administration (TGA) 🇦🇺 Find out about the Medical Devices Vigilance Program (MDVP) pilot, which aims to support Australian medical device sponsors to comply with their post-market vigilance responsibilities. 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 October 10, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on biocompatibility testing of medical devices for the ASCA Pilot Program. 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 September 19, 2023 Other (Public Domain) 0 reuses 0 favorites
Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on safety and performance standards for medical electrical equipment, systems, and laboratory equipment. 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 September 19, 2023 Other (Public Domain) 0 reuses 0 favorites
Outcomes of the Lower Risk Registered Over-the-Counter (OTC) Products Review Pilot Project From Therapeutic Goods Administration (TGA) 🇦🇺 The TGA has finalised the outcomes of the Lower Risk Registered OTC Products Review Pilot Project 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 July 12, 2023 Other (Non-Commercial) 0 reuses 0 favorites
The Health Canada eSTAR pilot program From Health Canada 🇨🇦 eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. 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 13, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Health Canada and FDA eSTAR pilot: Notice to industry From Health Canada 🇨🇦 eSTAR is an interactive PDF form that guides applicants through the process of preparing a comprehensive medical device submission. 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 13, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
EMA pilots scientific advice for certain high-risk medical devices From European Medicines Agency (EMA) 🇪🇺 EMA is testing scientific advice for high-risk 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 February 27, 2023 Other (Public Domain) 0 reuses 0 favorites
Information session on the pilot for expert panels’ scientific advice to manufacturers of high-risk medical devices From European Medicines Agency (EMA) 🇪🇺 Information session on pilot for expert panels' scientific advice to manufacturers of high-risk medical devices. 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 February 24, 2023 Other (Public Domain) 0 reuses 0 favorites
Clinical trials: Pilot phase procedure for the creation and processing of applications for medical devices From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Clinical trials: Pilot phase procedure for the creation and processing of applications 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 May 25, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Comprehensive Department of the State Drug Administration General Office of the National Health Commission Notice on the Establishment of the Pilot Work Sector Collaboration Working Group for the Unique Identification System for Medical Devices From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2020-1758 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 27, 2019 Other (Public Domain) 0 reuses 0 favorites
Notice of the Comprehensive Department of the State Drug Administration on the Pilot Training of the Unique Identification System for Medical Devices (Drug Supervision Comprehensive Machinery Note [2019] No. 381) From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2020-1755 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 10, 2024 Other (Public Domain) 0 reuses 0 favorites
State Drug Administration on the expansion of medical device registrant system pilot work notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2020-1372 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 1, 2019 Other (Public Domain) 0 reuses 0 favorites
Comprehensive Department of the State Drug Administration General Office of the State Health Commission on the issuance of the pilot program for the unique identification system for medical devices From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2020-1363 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 July 3, 2019 Other (Public Domain) 0 reuses 0 favorites
State Drug Administration on agreeing to carry out the pilot work of medical device registrant system approval reply From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2020-1706 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 16, 2018 Other (Public Domain) 0 reuses 0 favorites