Declare the discontinuation of a medical device or in vitro diagnostic medical device From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Procedure Declare a medical device or in vitro diagnostic medical device discontinued or no longer marketed 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 2 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Post-market review of spinal cord stimulation (SCS) devices From Therapeutic Goods Administration (TGA) 🇦🇺 Find out more about the post market review we are undertaking on spinal cord stimulators (SCS). 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
Market and technology trends From Ministry of Food and Drug Safety (MFDS) 🇰🇷 Document discussing current market and technology trends. 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 August 19, 2024 Other (Public Domain) 0 reuses 0 favorites
Chapter 4 - nicotine dose guidance Northern Ireland From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How to test and report levels of nicotine uptake when submitting a notification of intent to market e-cigarette and vape 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 August 16, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Chapter 4 - nicotine dose guidance - Great Britain From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How to test and report levels of nicotine uptake when submitting a notification of intent to market e-cigarette and vape products in Great Britain. 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 16, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Chapter 2 - product type guidance - Great Britain From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Which product type to select when submitting a notification of intent to market e-cigarette and vape products in Great Britain. 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 16, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Chapter 1.1 - submission type guidance Northern Ireland From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Which submission type to select when submitting a notification of intent to market e-cigarette and vape products in Northern Ireland. 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 16, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Chapter 1 - submission type guidance - Great Britain From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Which submission type to select when submitting a notification of intent to market e-cigarette and vape products in Great Britain. 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 16, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Notification of Post Market clinical investigation with additional invasive or burdensome procedures From Ministry of Health (Italy) (MDS) 🇮🇹 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 August 8, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Notification of initiation of clinical investigations Post Market From Ministry of Health (Italy) (MDS) 🇮🇹 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 August 8, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Unique Device Identifiers (UDI) From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Learn about Unique Device Identifiers (UDI) and their significance in gaining 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 August 5, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Register medical devices to place on the market From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland 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 2, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Market control of in vitro diagnostic medical devices From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document Controlling the market for in vitro diagnostic medical devices your approach 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 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical device market control From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document Controlling the medical device market in your approach 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Market surveillance of medical devices (MD) and in vitro diagnostic medical devices (IVDD) From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document Market surveillance of medical devices (MD) and in vitro diagnostic medical devices (IVDD) of your approach 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
GHTF Study Group 2 - Post-market Surveillance/Vigilance From International Medical Device Regulators Forum (IMDRF) 🌍 GHTF Study Group 2 - Post-market Surveillance/Vigilance documents 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 July 27, 2012 Other (Public Domain) 0 reuses 0 favorites
IVD sponsors: a roadmap to market From Therapeutic Goods Administration (TGA) 🇦🇺 This road map is intended for Australian sponsors of IVDs and presents an overview of the requirements for supplying an IVD under the new regulatory framework. 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 26, 2024 Other (Non-Commercial) 0 reuses 0 favorites
List of persons responsible for custom-made medical devices marketing From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document List of persons responsible for custom-made medical devices marketing 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 June 5, 2024 Other (Non-Commercial) 0 reuses 0 favorites
National register of breast prosthetic implants From Ministry of Health (Italy) (MDS) 🇮🇹 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,… 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 – Medical Devices – Part 822 Postmarket Surveillance From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 822 Postmarket Surveillance". 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