Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-10895. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying the ultrasound cyclodestructive device, a postamendments class III device (product code LZR), into class II (special controls), subject to premarket notification. FDA is… Metadata quality: Metadata quality: Data description filled Files documentation missing License filled Update frequency 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 1 day ago Other (Public Domain) 0 reuses 0 favorites
Expression of Interest for Medical Device Registration Voluntary Feasibility Study From South African Health Products Regulatory Authority (SAHPRA) 🇿🇦 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 2 days ago Other (Public Domain) 0 reuses 0 favorites
Safety information From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Safety information from the French Agency for the Safety of Medicines and Health Products 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 days ago Other (Non-Commercial) 0 reuses 0 favorites
Recalls and safety alerts From Health Canada 🇨🇦 Recall: 3611 results available. Alert: 16 results 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 2 days ago Open Government License 2.0 (Canada) 0 reuses 0 favorites
List of recalls and other field safety corrective actions (FSCA) From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Field safety information from Swissmedic: 9795 publications. 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 days ago Other (Non-Commercial) 0 reuses 0 favorites
Safety Alerts on Medical Devices From Ministry of Health (Italy) (MDS) 🇮🇹 Safety Alerts on 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 2 days ago Creative Commons Attribution 3.0 0 reuses 0 favorites
Medical devices regulations: compliance and enforcement From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Information on MHRA's enforcement duties and how to report a non-compliant medical device. 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 days ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Q&As on conditions of supply for rapid antigen point of care COVID-19 tests From Therapeutic Goods Administration (TGA) 🇦🇺 Answers to frequently asked questions in relation to rapid antigen point-of-care tests. 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 3 days ago Other (Non-Commercial) 0 reuses 0 favorites
Guide to Clinical Investigations carried out in Ireland From Health Products Regulatory Authority (HPRA) 🇮🇪 A guidance document outlining procedures for clinical investigations conducted in Ireland. 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 3 days ago Other (Public Domain) 0 reuses 0 favorites
Safety announcements from medical device manufacturers From Danish Medicines Agency (DKMA) 🇩🇰 Number of entries: 5154 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 3 days ago Other (Public Domain) 0 reuses 0 favorites
FOI disclosure log From Therapeutic Goods Administration (TGA) 🇦🇺 The Freedom of Information disclosure log gives access to information we've released in response to an FOI request. 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 3 days ago Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 rapid antigen self-tests (for home use) From Therapeutic Goods Administration (TGA) 🇦🇺 Information for sponsors, manufacturers and consumers on COVID-19 rapid antigen tests for self-testing 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 3 days ago Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 point-of-care tests From Therapeutic Goods Administration (TGA) 🇦🇺 Information about COVID-19 point-of-care tests. 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 3 days ago Other (Non-Commercial) 0 reuses 0 favorites
Breast Implant Expert and Consumer Working Groups From Therapeutic Goods Administration (TGA) 🇦🇺 The working group aims to provide clinical advice on breast implant and tissue expander medical devices to the TGA, including advice on breast implant associated cancer. 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 3 days ago Other (Non-Commercial) 0 reuses 0 favorites
Alerts - Medical Devices From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Last updated: 20/12/2018 The purpose of medical device alerts is to bring to the attention of healthcare professionals and/or users of such devices, the potential risks that may arise from their use and the measures to be taken to minimize or eliminate them. The dissemination of a medical... 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 3 days ago Other (Public Domain) 0 reuses 0 favorites
Legal supply of COVID-19 test kits From Therapeutic Goods Administration (TGA) 🇦🇺 Updated information about the legal supply of COVID-19 test kits 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 3 days ago Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 in vitro diagnostics - Guidance on ongoing requirements for sponsors and manufacturers From Therapeutic Goods Administration (TGA) 🇦🇺 A guide for sponsors of COVID-19 IVDs about their ongoing obligations 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 3 days ago Other (Non-Commercial) 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 3 days ago Other (Non-Commercial) 0 reuses 0 favorites
Clinical trials From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 This document discusses clinical trials. 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 3 days ago Other (Non-Commercial) 0 reuses 0 favorites
Preliminary re-assessment review (PRAR) form template (MDR) From European Commission 🇪🇺 A template for the Preliminary Re-assessment review (PRAR) form under the MDR. 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 3 days ago Creative Commons Attribution 4.0 0 reuses 0 favorites