How to declare if you are a manufacturer or distributor of in vitro diagnostic medical devices From National Agency for the Safety of Medicines and Health Products (ANSM) ๐ซ๐ท Reference document How to declare if you are a manufacturer or distributor of in vitro diagnostic medical devices in your application 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 August 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
National Register of Breast Prosthetic Implants - Appointment of data submission manager for distributors From Ministry of Health (Italy) (MDS) ๐ฎ๐น Medical devices - Online forms and services 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 25, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
National register of breast prosthetic implants From Ministry of Health (Italy) (MDS) ๐ฎ๐น Breast implants , commonly implanted for cosmetic or reconstructive reasons, are class III medical devices, the highest risk class, regulated by Legislative Decree No. 137 of August 5, 2022 and EU Regulation 745/2017 . The Ministry of Health, as the Competent Authority on medical devices in Italy,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 June 5, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 801 Labeling From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 801 Labeling". 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 4, 2024 Other (Public Domain) 0 reuses 0 favorites
COVID-19 test approval: how to apply From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง How test manufacturers or distributors can apply for approval of their tests to sell on the UK 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 May 24, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Distributor registration From National Institute of Pharmacy and Nutrition (OGYรI) ๐ญ๐บ A document outlining the process and requirements for medical devices distributors. 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 9, 2024 Other (Public Domain) 0 reuses 0 favorites
How to declare if you are a manufacturer or distributor of medical devices From National Agency for the Safety of Medicines and Health Products (ANSM) ๐ซ๐ท Reference document How to declare if you are a manufacturer or distributor of medical devices in your application 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 August 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 health product industry From Health Canada ๐จ๐ฆ Links to COVID-19-related information for health product manufacturers and distributors of diagnostic tests, ventilators, hand sanitizers and disinfectants. 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 15, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 From European Commission ๐ช๐บ Get answers to questions about Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 regarding authorised representatives, importers, and distributors. 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 December 20, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Obligations for authorised representatives, importers and distributors From Swiss Agency for Therapeutic Products (Swissmedic) ๐จ๐ญ 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
COVID-19 medical devices From Health Canada ๐จ๐ฆ Information for medical device manufacturers, distributors and health professionals in relation to COVID-19. 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 September 15, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 895 Banned 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 895 Banned 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
Executive order on fees for importers and distributors of medical devices etc. From Danish Medicines Agency (DKMA) ๐ฉ๐ฐ An executive order outlining new fee regulations for importers and distributors of medical devices and related products. 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 20, 2023 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 821 Medical Device Tracking Requirements From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "Medical Device Tracking Requirements" under 21 CFR Chapter I Subchapter H. 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
MDR Newsletter 6/2022: Distributor registration - technical details, answers to frequently asked questions From National Institute of Pharmacy and Nutrition (OGYรI) ๐ญ๐บ A newsletter for the sixth month of 2022 covering distributor registration technical details and FAQs. 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
MDR/IVDR Newsletter 10/2022: Basics about IVD devices in the light of the IVDR or what devices I need to register as an IVD distributor From National Institute of Pharmacy and Nutrition (OGYรI) ๐ญ๐บ A newsletter discussing the basics of in vitro diagnostic (IVD) devices under the In Vitro Diagnostic Regulation (IVDR) and registration requirements for IVD distributors. 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
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 (OGYรI) ๐ญ๐บ 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
"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
Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746 From European Commission ๐ช๐บ Get guidance on the regulations for Authorised Representatives, Importers, and Distributors in the EU (Regulation (EU) 2017/745 and Regulation (EU) 2017/746). 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