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
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
Preliminary re-assessment review (PRAR) form template (IVDR) From European Commission 🇪🇺 A template for the Preliminary Re-assessment Review (PRAR) form under the IVDR. 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
Preliminary assessment review (PAR) form template (MDR) From European Commission 🇪🇺 A template for Preliminary Assessment Review (PAR) 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
Preliminary assessment review (PAR) form template (IVDR) From European Commission 🇪🇺 A template for Preliminary Assessment Review (PAR) form under the IVDR. 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
Good Clinical Practice (GCP) Inspection Program From Therapeutic Goods Administration (TGA) 🇦🇺 Clinical trials of medicines and biologicals regulated under the CTN or CTA schemes are subject to the TGA's Good Clinical Practice (GCP) Inspection Program. 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 4 days ago Other (Non-Commercial) 0 reuses 0 favorites
Remanufacturing of Medical Devices: Guidance for Industry, Entities That Perform Servicing or Remanufacturing, and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 A guidance document focusing on labeling requirements for the remanufacturing of medical devices, aimed at industry entities 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 not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated 1 week ago Other (Public Domain) 0 reuses 0 favorites
Regulation of software based medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Software based medical devices are medical devices that incorporate software or are software. 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 1 week ago Other (Non-Commercial) 0 reuses 0 favorites
Send and receive information on adverse drug reactions (ADRs) From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine. 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 1 week ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Software and artificial intelligence (AI) as a medical device From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD). 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 2 weeks ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
BW303_00_003e_WL Guidance document Change name or domicile of the authorisation holder From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Guidance document on changing the name or domicile of the authorization holder. 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 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
BW302_00_001e_WL Guidance document for requesting product certificates (CPP) From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Guidance document for requesting product certificates. 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 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Boundary and combination products From Therapeutic Goods Administration (TGA) 🇦🇺 A guide to help sponsors figure out if their therapeutic goods are medicines, biologicals, or 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 2 weeks ago Other (Non-Commercial) 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