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
Alerts and recalls of medical products - ANMAT From National Administration of Drugs, Food and Medical Devices (ANMAT) ๐ฆ๐ท Stay informed about safety alerts and recalls of medical products with ANMAT's comprehensive database. 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 1 week ago Creative Commons Attribution 4.0 0 reuses 0 favorites
Medical device reforms: establishment of a Unique Device Identification system From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Strengthened patient safety through the establishment of a UDI database for 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 1 month ago Other (Non-Commercial) 0 reuses 0 favorites
The Australian UDI Database for sponsors and manufacturers From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Understand what the Australian UDI database is and how to use it. 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 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Australian UDI Database release notes From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Read the latest enhancements and fixes to the Australian UDI Database. 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Draft Australian UDI Bulk Upload Template From Therapeutic Goods Administration (TGA) ๐ฆ๐บ A Microsoft Excel template for sponsors and manufacturers for uploading bulk UDI records to the Australian UDI Database 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 16, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Draft Australian UDI Data Dictionary From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The Australian UDI Data Dictionary includes a list of the fields in the database, including element names, descriptions, permitted values and other metadata. 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
System for Australian Recall Actions (SARA) database From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Learn about SARA, the publicly searchable database where we publish information about recall actions involving therapeutic goods in the Australian market. 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 Search & view From European Commission ๐ช๐บ This document provides guidance on how to search and view information within the EUDAMED database, facilitating access to relevant data efficiently. 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
EUDAMED โ Manage From European Commission ๐ช๐บ This document provides guidance on managing the European Database on Medical Devices (EUDAMED), covering key aspects and procedures for effective utilization. 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
EUDAMED โ Acronyms From European Commission ๐ช๐บ A comprehensive list of acronyms related to EUDAMED, providing a quick reference guide for understanding key terms in the context of the European medical device database. 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 20, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Registration of in vitro diagnostic medical devices in the national database From Ministry of Health (Italy) (MDS) ๐ฎ๐น Waiting for the fully functionality of European Database Eudamed , at the moment in Italy the obligations provided for in Article 10 of Legislative Decree 332/2000 shall continue to apply, untill twenty-four months after the date of the publication of the notice on the functionality of Eudamed. 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 14, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Unique device identification system From Ministry of Health (Italy) (MDS) ๐ฎ๐น The unique device identification system ("UDI system") provided for in the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Devices (IVD) Regulation (EU) 2017/746 allows for the identification and facilitates the traceability of devices. The system involves: assigning a basicโฆ 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 12, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
EUDAMED Actor module From National Institute of Pharmacy and Nutrition (OGYรI) ๐ญ๐บ A document detailing the EUDAMED Actor module, discussing actors involved in the European Database on 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 February 9, 2024 Other (Public Domain) 0 reuses 0 favorites
The European Medical Device Nomenclature (EMDN) From Ministry of Health (Italy) (MDS) ๐ฎ๐น Per Article 26 of Regulation (EU) 2017/745 on medical devices (MDR) and Article 23 of Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR), the European Medical Device Nomenclature (EMDN) aims at supporting the functioning of the European database on medical devices (EUDAMED).โฆ 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 1, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Cancellations From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The TGA maintains a database listing all cancellations from the Australian Register of Therapeutic Goods. 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 16, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Usage information flow From Ministry of Health (Italy) (MDS) ๐ฎ๐น The Decree of the Minister of Health June 11, 2010, provided for the establishment of the database for monitoring medical devices that healthcare facilities directly managed by the National Health Service purchase or make available for use. The database is fed by individual regions and also coversโฆ 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 October 13, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Medical devices regulation basics From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The Australian Register of Therapeutic Goods (ARTG) is the central database of therapeutic goods that can be legally supplied in or exported from Australia. 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 25, 2023 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 830 Unique Device Identification From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 830 Unique Device Identification". 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
Questions and Answers (Q&A) on Points to Consider for Ensuring the Reliability in Utilization of Data from Registry or Medical Information Database in Applications for Marketing Approval and Re-examination for Regenerative Medical Products From Pharmaceuticals and Medical Devices Agency (PMDA) ๐ฏ๐ต PSEHB/MDED Administrative Notice 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, 2023 Other (Public Domain) 0 reuses 0 favorites