MHRA Strategy for Improving Safety Communications From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง The MHRAโs strategy for Improving Safety Communications for 2024 to 2027. 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 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Mpox Diagnostic Tests From South African Health Products Regulatory Authority (SAHPRA) ๐ฟ๐ฆ Document Number MD01-2023/24 - 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 1 week ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 890 Physical Medicine Devices From Food and Drug Administration (FDA) ๐บ๐ธ Regulation on physical medicine devices under 21 CFR Chapter I Subchapter H - Medical Devices - Part 890. 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
Contact details for Guideline SAHPGL-MD-03 Medical Device Vigilance: Adverse Events Reporting for License Holders From South African Health Products Regulatory Authority (SAHPRA) ๐ฟ๐ฆ 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
Expression of Interest for Medical Device Registration Voluntary Feasibility Study From South African Health Products Regulatory Authority (SAHPRA) ๐ฟ๐ฆ 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 May 17, 2024 Other (Public Domain) 0 reuses 0 favorites
Recall action templates From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Templates to help you with your communications under the Uniform recall procedure for therapeutic goods (URPTG). 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 March 26, 2024 Other (Non-Commercial) 0 reuses 0 favorites
EUDAMED โ Machine-to-machine From European Commission ๐ช๐บ This document provides information on the EUDAMED system and its machine-to-machine communication capabilities for efficient data exchange in healthcare. 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 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Communication on the European Medical Device Nomenclature (EMDN) From National Organization for Medicines (EOF) ๐ฌ๐ท To see the announcement, click 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 February 15, 2024 Other (Public Domain) 0 reuses 0 favorites
Communication on the European Commission's survey on monitoring the availability of Medical Devices (MD) on the European Union market From National Organization for Medicines (EOF) ๐ฌ๐ท To see the announcement, click 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 December 6, 2023 Other (Public Domain) 0 reuses 0 favorites
SAHPRA position on EU regulatory transition for medical devices from MDD/AIMDD/IVDD to MDR 2017/745 /IVDR 2017/746 From South African Health Products Regulatory Authority (SAHPRA) ๐ฟ๐ฆ Document Number MD038 - 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 October 2, 2023 Other (Public Domain) 0 reuses 0 favorites
How tests and testing kits for coronavirus (COVID-19) work From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง The different types of tests and testing kits for COVID-19, and the specifications for manufacturers. 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 8, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Reporting system for in vitro diagnostic medical devices From Ministry of Health (Italy) (MDS) ๐ฎ๐น The Ministry of Health carries out the activities of monitoring and investigating reports from healthcare professionals and manufacturers. On Sept. 28, 2022, Legislative Decree No. 138 of Aug. 5, 2022 , came into force, which in Article 13 provides fulfillments for manufacturers of in vitroโฆ 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 3, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 892 Radiology Devices From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 892 Radiology 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 on June 7, 2023 Other (Public Domain) 0 reuses 0 favorites
How to draft a direct healthcare professional communication From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง Guidance for marketing authorisation holders on drafting direct healthcare professional communications (DHPCs) 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 4, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 810 Medical Device Recall Authority From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 810 Medical Device Recall Authority". 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
Referencing the Definition of "Device" in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ A guidance document titled "Referencing the Definition of 'Device' in the Federal Food, Drug, and Cosmetic Act" for industry 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 filled Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 66.66666666666666/100 Updated on November 10, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Device Data Systems, Medical Image Storage Devices, and Medical Image Communications Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document provides guidance for the industry and FDA staff on medical device data systems, image storage devices, and image communications devices. 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 on September 27, 2022 Other (Public Domain) 0 reuses 0 favorites
Medical Device Establishment Licence Renewal Process From South African Health Products Regulatory Authority (SAHPRA) ๐ฟ๐ฆ Document Number MD031 - Version 2 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 22, 2022 Other (Public Domain) 0 reuses 0 favorites
ISO 13485 Conformity Assessment Body Communication From South African Health Products Regulatory Authority (SAHPRA) ๐ฟ๐ฆ Document Number MD032 - Version 2 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 August 19, 2022 Other (Public Domain) 0 reuses 0 favorites
Withdrawal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators From South African Health Products Regulatory Authority (SAHPRA) ๐ฟ๐ฆ Document Number MD037 - 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 22, 2022 Other (Public Domain) 0 reuses 0 favorites