Economic operators From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 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
EUDAMED – User guides and templates From European Commission 🇪🇺 This document provides user guides and templates for EUDAMED, a system for medical device registration and monitoring in the EU. 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 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
EUDAMED – Topics per Actor From European Commission 🇪🇺 This document provides an overview of topics related to EUDAMED system categorized by different actors involved in the process. 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 – Starting and ending a EUDAMED session From European Commission 🇪🇺 This document provides guidelines on how to initiate and conclude a session in EUDAMED, offering detailed steps and instructions for users. 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 – Manage From European Commission 🇪🇺 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
Swiss authorised representative (CH-REP) From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Learn about the Swiss authorised representative (CH-REP) and how it facilitates market access. 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 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Obligations for authorised representatives, importers and distributors From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Learn about the obligations for authorised representatives, importers, and distributors in relation to market access. 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 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Reporting system for in vitro diagnostic medical devices From Ministry of Health (Italy) (MDS) 🇮🇹 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 vitro… 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
MDR Circular 5/2022: On certain aspects of the labelling and instruction handbook insurance activities of importers, distributors (and other economic operators), i.e. Article 16 of the MDR From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter discussing MDR Circular 5/2022 focusing on labelling, instruction handbook insurance activities for importers, distributors, and other economic operators under Article 16 of the MDR. 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 29, 2023 Other (Public Domain) 0 reuses 0 favorites
FAQ Regulation MD - Obligations of economic operators From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document FAQ MD regulation - Economic operator obligations in your application process 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 24, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Registering medical devices in the national database From Ministry of Health (Italy) (MDS) 🇮🇹 The medical devices sector is undergoing a transitional period in which some provisions set out by Regulation (EU) 2017/745 (MDR), such as the registration of economic operators and medical devices, although mandatory from the date of application of the Regulation, cannot be met according to the… 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 January 13, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Normative Instruction - IN No. 119 of 23/02/2022 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Provides for the technical attributes of medical devices selected for economic monitoring by Anvisa. 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 March 2, 2022 Other (Public Domain) 0 reuses 0 favorites
Normative Instruction - IN No. 84 of 12/03/2021 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Provides for the list of medical devices selected for economic monitoring by Anvisa. 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 March 17, 2021 Other (Public Domain) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 478 of 12/03/2021 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Provides for the economic monitoring of 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 on March 17, 2021 Other (Public Domain) 0 reuses 0 favorites
Commission Directive 2011/100/EU of 20 December 2011 amending Directive 98/79/EC of the European Parliament and of the Council on in-vitro diagnostic medical devices Text with EEA relevance From European Parliament 🇪🇺 Commission Directive 2011/100/EU amends Directive 98/79/EC on in-vitro diagnostic medical devices. Relevant for the European Economic Area. 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 20, 2011 Creative Commons Attribution 4.0 0 reuses 0 favorites
2011/869/EU: Commission Decision of 20 December 2011 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (notified under document C(2011) 9398) Text with EEA relevance From European Parliament 🇪🇺 Commission Decision amending technical specifications for in vitro diagnostic medical devices. Relevant for the European Economic Area. 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 20, 2011 Creative Commons Attribution 4.0 0 reuses 0 favorites
Opinion of the Economic and Social Committee (2002/C 48/16) From European Commission 🇪🇺 Opinion of the Economic and Social Committee (2002/C 48/16) 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 21, 2002 Creative Commons Attribution 4.0 0 reuses 0 favorites
Notice on the continuation of reporting on efforts to rectify and standardize the economic order in the pharmaceutical market From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2001-10028 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, 2001 Other (Public Domain) 0 reuses 0 favorites
Registering economic operators (CHRN) From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Learn how to register economic operators for market access with the CHRN. 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 April 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites