GeGant From European Medicines Agency (EMA) 🇪🇺 Information about marketing authorisation application of GeGant, a device to obtain a solution containing radioactive gallium. Metadata quality: Metadata quality: Data description filled 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: 66.66666666666666/100 Updated on April 26, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 814 Premarket Approval of Medical Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 814 Premarket Approval of 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 March 18, 2024 Other (Public Domain) 0 reuses 0 favorites
The Medical Devices (In Vitro Diagnostic Devices etc.) (Amendment) Regulations 2024 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations make provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/746 of the European Parliament and of the Council of 5 April 2017 on in vitro diagnostic medical devices and repealing Directive 98/79/EC and Commission Decision 2010/227/EU (“Regulation… 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 22, 2024 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 860 Medical Device Classification Procedures From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "Medical Device Classification Procedures" 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 July 17, 2023 Other (Public Domain) 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
Withdrawal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators From South African Health Products Regulatory Authority (SAHPRA) 🇿🇦 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
The Medical Devices (Northern Ireland Protocol) Regulations 2021 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations make provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and… 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 27, 2021 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
The Human Medicines and Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations are made in exercise of the powers conferred by section 8(1) of, and paragraph 21 of Schedule 7 to, the European Union (Withdrawal) Act 2018 (c. 16) (“the Withdrawal Act”) in order to address failures of retained EU law to operate effectively and other deficiencies (in particular… 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, 2020 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations are made in exercise of the powers in sections 8(1) and 8C of the European Union (Withdrawal) Act 2018 (c. 16) in order to address failures of retained EU law to operate effectively and other deficiencies (in particular under section 8(2)(a)) arising from the withdrawal of 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 December 8, 2020 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
eCTD withdrawals From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance for sponsors who need to withdraw information from their eCTD dossiers and can be used as best practice for NeeS withdrawals 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 30, 2020 Other (Non-Commercial) 0 reuses 0 favorites
Recognition and Withdrawal of Voluntary Consensus Standards: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for industry and FDA staff on the recognition and withdrawal of voluntary consensus standards. 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 14, 2020 Other (Public Domain) 0 reuses 0 favorites
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2019 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations are made in exercise of the powers conferred by section 8(1) of , paragraph 7(2) of Schedule 4 and paragraph 21 of Schedule 7 to the European Union (Withdrawal) Act 2018 (c. 16) (“the Withdrawal Act”) in order to address failures of retained EU law to operate effectively and… 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 26, 2020 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
Press release on the medical device SUPROFILM From National Organization for Medicines (EOF) 🇬🇷 On the occasion of the withdrawal of the Certification of the medical device SUPROFILM®, produced by KLAS MEDIKAL, by the Notified Body of ... 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 28, 2012 Other (Public Domain) 0 reuses 0 favorites