Chapter 10 - general advice on vigilance - Great Britain From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Collecting and acting on information on any adverse effects of electronic cigarette devices and refill containers on human health. 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 16, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Medical devices - Vigilance notification From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document Medical devices - Vigilance notification in your application process 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 13, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Declaring/recording activities of operators, medical devices, assemblies (systems/accessories), and person in charge of MD vigilance From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Approach Declaring/recording activities of operators, medical devices, assemblies (systems/accessories), and the person in charge of MD vigilance 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 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Review of incidents and vigilance investigations involving medical devices From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document Review of incidents and vigilance investigations of medical devices in your approach 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Contact details for Guideline SAHPGL-MD-03 Medical Device Vigilance: Adverse Events Reporting for License Holders From South African Health Products Regulatory Authority (SAHPRA) 🇿🇦 Document Number MD01-2024/2025 - Version 1 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 July 9, 2024 Other (Public Domain) 0 reuses 0 favorites
Users From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 This document is about users and focuses on 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 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical devices - Clinical investigations vigilance From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Procedure Medical devices - Vigilance of clinical investigations 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 24, 2024 Other (Non-Commercial) 0 reuses 0 favorites
In vitro diagnostic medical devices - Performance studies vigilance From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Procedure In vitro diagnostic medical devices - Vigilance of performance studies 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 24, 2024 Other (Non-Commercial) 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
Desktop audit (DTA) and on-site inspection From Therapeutic Goods Administration (TGA) 🇦🇺 Under the Medical Device Vigilance Program, we will conduct desktop audits and on-site inspections. 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
Incident reporting by patients From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Last update: November 10, 2020 Medical device incident reporting Medical device vigilance system: incident reporting by patients and users What is a Medical Device? What is the Medical Device Vigilance System? What can I report? Who can report? How can I report? How can I report? 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
Incident reporting by companies From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Last update: November 23, 2021 Included are the notification forms for the Guidelines on the Medical Device Vigilance System that can be completed and submitted by email to psvigilancia@aemps.es or by fax to +34918225289 Notification Form. Incident Report of 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
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
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
Information on the medical device vigilance system and on the functions of the person in charge of vigilance at the health care facilities From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Pdf format Date of update: June 29, 2015 Reference: AEMPS/CTI-PS/June 2015 This document is addressed to the Heads of Vigilance of Medical Devices of the Health Centers and has been prepared jointly with the Autonomous Communities within the Technical Committee of Inspection of the AEMPS... 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 Other (Public Domain) 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
DSVG 05 on Urogynaecological Surgical Mesh Implants used for Pelvic Organ Prolapse repair and Stress Urinary Incontinence From European Commission 🇪🇺 Document discusses DSVG 05 guidelines on Urogynaecological Surgical Mesh Implants for Pelvic Organ Prolapse and Stress Urinary Incontinence, focusing on Post-Market Surveillance and Vigilance (PMSV). 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 June 27, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Registration of implantable medical devices From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Date of publication: June 13, 2023 The purpose of the National Implant Registries is to provide information for the greater effectiveness of the Medical Devices Vigilance System by making it possible to quickly locate patients carrying a given implant. Likewise, this information contributes to 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 May 27, 2024 Other (Public Domain) 0 reuses 0 favorites
Vigilance From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 This docuemnt discusses vigilance of healthcare institutions. 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 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
AEMPS Information Notes From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 AEMPS Information Notes on Medical Device 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 April 16, 2024 Other (Public Domain) 0 reuses 0 favorites