Medical Device Recalls From Food and Drug Administration (FDA) ๐บ๐ธ 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
Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ A guidance document outlining the Voluntary Malfunction Summary Reporting (VMSR) Program for Manufacturers, providing guidance 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 not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated 3 weeks ago Other (Public Domain) 0 reuses 0 favorites
Regulatory changes for software based medical devices From Therapeutic Goods Administration (TGA) ๐ฆ๐บ This guidance provides a summary of changes to the regulation of software based medical devices (including software as a medical device). 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, 2024 Other (Non-Commercial) 0 reuses 0 favorites
National Symposium on Point-of-care Manufacturing of medical devices From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Read the meeting summary for the National Symposium on Point-of-care Manufacturing of medical devices, held on 19 June 2023. 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 24, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Summary of fees and charges From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Summary of fees and charges. 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Summary of fees and charges to applications submitted to the TGA From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Find out about fees and charges that apply from July 2024. 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 20, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Economic operators From Swiss Agency for Therapeutic Products (Swissmedic) ๐จ๐ญ Learn about economic operators and their role in reporting incidents and FSCAs (vigilance). 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 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Common specification requirements for in vitro diagnostic devices From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง MHRA seeks views on possible amendments to the Medical Devices Regulations 2002 to include common specification requirements for manufacturers of IVD 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 May 21, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Summary of safety and performance template From European Commission ๐ช๐บ A document titled "Summary of safety and performance template" covering topics related to In Vitro Diagnostic medical devices (IVD). 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 April 15, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of 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 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of 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 March 18, 2024 Other (Public Domain) 0 reuses 0 favorites
TIWGG meeting summaries From Therapeutic Goods Administration (TGA) ๐ฆ๐บ TGA-Industry Working Group on Good Manufacturing Practice (TIWGG) meeting summaries. 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 22, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Mandatory reporting of serious adverse drug reactions and medical device incidents by hospitals: Overview From Health Canada ๐จ๐ฆ Summary of guidance for hospitals about achieving compliance with federal regulatory requirement to report serious ADRs and MDIs to Health Canada. 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 December 18, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 861 Procedures for Performance Standards Development From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "Procedures for Performance Standards Development" under 21 CFR Chapter I Subchapter H - Medical 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 July 17, 2023 Other (Public Domain) 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
A summary of supplying therapeutic goods in Australia From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The six steps you need to follow when considering making an application to the TGA 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 24, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Commission Guidance on the content and structure of the summary of the clinical investigation report From European Commission ๐ช๐บ Document provides guidance on the content and structure of the summary of clinical investigation reports, focusing on clinical investigation and evaluation. 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, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
"Presentation of the National Register of Medical Devices (NOR) and other distributor obligations" online conference held on 21 October 2021 in the framework of the EFOP-1.8.10-VEKOP-17-2017-00001 project From National Institute of Pharmacy and Nutrition (OGYรI) ๐ญ๐บ A summary of an online conference discussing distributor obligations within the EFOP-1.8.10-VEKOP-17-2017-00001 project on 21 October 2021. 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 December 9, 2022 Other (Public Domain) 0 reuses 0 favorites
Summary reporting provisions of the Medical Devices Regulations: Notice to industry From Health Canada ๐จ๐ฆ The amended Medical Device Regulations (regulations) that describe summary reporting provisions have been in effect since December 23, 2021 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 21, 2022 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Appendix: Clinical investigation summary safety report form From European Commission ๐ช๐บ This document is an appendix that provides a summary safety report form for clinical investigations and evaluations. 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 September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
TGA actions following 2018 stakeholder surveys From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Summary of our actions following the 2018 TGA stakeholder survey 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 4, 2022 Other (Non-Commercial) 0 reuses 0 favorites