21 CFR Chapter I Subchapter H – Medical Devices – Part 872 Dental Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 872 Dental Devices". 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 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
Guide to Fees for Human Products From Health Products Regulatory Authority (HPRA) 🇮🇪 A guidance document outlining fees associated with human products. 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 3, 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
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 on May 16, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 821 Medical Device Tracking Requirements From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "Medical Device Tracking Requirements" under 21 CFR Chapter I Subchapter H. 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 March 31, 2023 Other (Public Domain) 0 reuses 0 favorites
Guide to Applications for Certificates of Free Sale for Medical Devices From Health Products Regulatory Authority (HPRA) 🇮🇪 A guidance document outlining the process and requirements for applying for Certificates of Free Sale for medical devices. 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 May 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Serious adverse drug reactions and medical device incidents - Canada.ca From Health Canada 🇨🇦 A summary of serious adverse drug reactions and medical device incidents reported by hospitals and tracked in the Canada Vigilance database. 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 May 15, 2022 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guide for Distributors of Medical Devices From Health Products Regulatory Authority (HPRA) 🇮🇪 A guidance document aimed at distributors of medical devices, providing instructions and information on relevant processes and regulations. 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 May 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Guide for Suppliers of First Aid Kits Containing Medicinal Products Supplying Solely to the End-User From Health Products Regulatory Authority (HPRA) 🇮🇪 A guidance document for suppliers of first aid kits containing medicinal products, focusing on supplying solely to the end-user. 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 May 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Medical Device Tracking : Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 Guidance document providing information on medical device tracking for industry and FDA staff. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on March 24, 2020 Other (Public Domain) 0 reuses 0 favorites
Guide to Information held by the HPRA From Health Products Regulatory Authority (HPRA) 🇮🇪 A guidance document providing information on the data held by the HPRA. 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 May 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Regulation on Submission of Records and Documents of Medical Devices Subject to Tracking From Ministry of Food and Drug Safety (MFDS) 🇰🇷 Regulation on Submission of Records and Documents of Medical Devices Subject to Tracking 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 31, 2016 Other (Public Domain) 0 reuses 0 favorites
Regulation on Designation of Medical Devices Subject to Tracking From Ministry of Food and Drug Safety (MFDS) 🇰🇷 Regulation on Designation of Medical Devices Subject to Tracking 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 March 31, 2016 Other (Public Domain) 0 reuses 0 favorites
Guide to Vigilance System for Medical Devices From Health Products Regulatory Authority (HPRA) 🇮🇪 A guidance document outlining the vigilance system 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 May 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Guide to Refusals and Appeals From Health Products Regulatory Authority (HPRA) 🇮🇪 A document providing guidance on refusals and appeals. 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 May 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Guide to Incident Reporting for In-vitro Diagnostic Medical Devices From Health Products Regulatory Authority (HPRA) 🇮🇪 A guidance document providing instructions on incident reporting for in-vitro diagnostic medical devices. 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 May 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Guide to In-Vitro Diagnostic Medical Devices Legislation From Health Products Regulatory Authority (HPRA) 🇮🇪 A guidance document outlining legislation for in-vitro diagnostic 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 May 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Guide to Field Safety Corrective Actions for Medical Devices and In-vitro Diagnostic Medical Devices From Health Products Regulatory Authority (HPRA) 🇮🇪 A guidance document outlining procedures for Field Safety Corrective Actions for Medical Devices and In-vitro Diagnostic Medical Devices. 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 May 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Guide for Manufacturers of General Class In-vitro Diagnostic Medical Devices From Health Products Regulatory Authority (HPRA) 🇮🇪 A guidance document for manufacturers of general class in-vitro diagnostic 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 May 8, 2024 Other (Public Domain) 0 reuses 0 favorites