Medical Devices News & Events From Health Products Regulatory Authority (HPRA) 🇮🇪 Recently published news and upcoming events related to medical devices. Metadata quality: Metadata quality: Data description empty 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: 66.66666666666666/100 Updated 1 day ago Other (Public Domain) 0 reuses 0 favorites
Medical Device Recalls From Food and Drug Administration (FDA) 🇺🇸 Summaries of information about the most serious medical device recalls. These products are on the list because there is a reasonable chance that they could cause serious health problems or death. 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 14, 2024 Other (Public Domain) 0 reuses 0 favorites
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
Conducting Remote Regulatory Assessments Questions and Answers: Draft Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 Draft guidance document providing questions and answers on conducting remote regulatory assessments for various topics including adverse event reporting, compliance, and pharmaceutical quality. 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
21 CFR Chapter I Subchapter H – Medical Devices – Part 880 General Hospital and Personal Use Devices From Food and Drug Administration (FDA) 🇺🇸 21 CFR Chapter I Subchapter H - Medical Devices - Part 880 General Hospital and Personal Use Devices. Regulation. 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 August 19, 2024 Other (Public Domain) 0 reuses 0 favorites
Adverse event report From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A form intended for reporting adverse events related to 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 July 25, 2024 Other (Public Domain) 0 reuses 0 favorites
Report an adverse event or problem (industry) From Therapeutic Goods Administration (TGA) 🇦🇺 As the sponsor of a medicine or a medical device in Australia, you have a responsibility to report adverse events. 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 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Report an adverse event or problem (health professionals) From Therapeutic Goods Administration (TGA) 🇦🇺 Report an adverse event or problem related to a medicine, vaccine or medical device as a health professional. 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 11, 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
GHTF Study Group 2 - Post-market Surveillance/Vigilance From International Medical Device Regulators Forum (IMDRF) 🌍 GHTF Study Group 2 - Post-market Surveillance/Vigilance documents 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 July 27, 2012 Other (Public Domain) 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
Report an adverse event or incident From Therapeutic Goods Administration (TGA) 🇦🇺 Information on how to report an adverse event or drug reaction for medicines, biologicals and 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 June 5, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Reporting of serious adverse events and device defects in performance studies with IVDs From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Online forms and services 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 May 28, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Report an adverse event or problem (consumers) From Therapeutic Goods Administration (TGA) 🇦🇺 You can report a side effect, reaction or other problem with a therapeutic good. Your report can help keep others safe. 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 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes From International Medical Device Regulators Forum (IMDRF) 🌍 Technical document: IMDRF/AE WG/N43FINAL:2020 (Edition 4) - Annexes and release notes updated annually Current release: IMDRF/AE WG/N43FINAL:2024 Updated Annexes 20 April 2024; Annex A_1 – updated 9 May 2024 (refer release notes for details) 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 7, 2024 Other (Public Domain) 0 reuses 0 favorites
Report a problem or side effect From Therapeutic Goods Administration (TGA) 🇦🇺 Reporting adverse events (side effects to medicines and problems with medical devices) helps make medicines and medical devices safer for everyone. 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 November 15, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Help us promote adverse event reporting: promotional resources kit From Therapeutic Goods Administration (TGA) 🇦🇺 You can help by sharing our messages on social media, your website and around your workplace. 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 November 3, 2023 Other (Non-Commercial) 0 reuses 0 favorites
How TGA manages medical device adverse event reports From Therapeutic Goods Administration (TGA) 🇦🇺 Learn how we manage medical device adverse event reports. 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 November 3, 2023 Other (Non-Commercial) 0 reuses 0 favorites
GN-05-R3 Guidance on the Reporting of Adverse Events (2023 Sep) PUB From Health Sciences Authority (HSA) 🇸🇬 Provides instructions on reporting adverse events 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 1, 2023 Other (Public Domain) 0 reuses 0 favorites