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
Policy Clarification and Premarket Notification [510(k)] Submissions for Ultrasonic Diathermy Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA staff on policy clarification and premarket notification for ultrasonic diathermy devices. 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 February 21, 2023 Other (Public Domain) 0 reuses 0 favorites
Clarification on “first certification for that type of device” and corresponding procedures to be followed by notified bodies, in context of the consultation of the expert panel referred to in Article 48(6) of Regulation (EU) 2017/746 From European Commission 🇪🇺 This document provides clarification on the first certification for in vitro diagnostic medical devices and the procedures for notified bodies to follow. 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
Clarification of Radiation Control Regulations For Manufacturers of Diagnostic X-Ray Equipment: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a draft guidance for manufacturers of diagnostic X-ray equipment, providing clarification on radiation control regulations. Topics covered include export, import, and labeling. 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 April 26, 2021 Other (Public Domain) 0 reuses 0 favorites
State Drug Administration Comprehensive Division on the clarification of the "Medical Device Inspection Code of Practice" labeling accreditation mark related matters notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2020-10001 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 December 8, 2020 Other (Public Domain) 0 reuses 0 favorites
Submissions received: Proposed clarification of the regulatory requirements for medical device systems or procedure packs From Therapeutic Goods Administration (TGA) 🇦🇺 The TGA thanks respondents who provided submissions in response to the public consultation paper 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 2, 2020 Other (Non-Commercial) 0 reuses 0 favorites
Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 3) From Food and Drug Administration (FDA) 🇺🇸 Guidance document providing clarification on radiation control regulations for diagnostic X-ray equipment (Part 3). 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 March 2, 2020 Other (Public Domain) 0 reuses 0 favorites
Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 2) From Food and Drug Administration (FDA) 🇺🇸 A memorandum providing clarification on radiation control regulations for diagnostic X-ray equipment. 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 March 2, 2020 Other (Public Domain) 0 reuses 0 favorites
Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (Part 1 ) From Food and Drug Administration (FDA) 🇺🇸 Guidance document providing clarification on radiation control regulations for diagnostic X-ray equipment (Part 1). 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 March 2, 2020 Other (Public Domain) 0 reuses 0 favorites
Policy Clarification for Certain Fluoroscopic Equipment Requirements: 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 policy clarification for certain fluoroscopic equipment requirements. 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 May 7, 2019 Other (Public Domain) 0 reuses 0 favorites
Clarification of Radiation Control Regulations for Diagnostic X-Ray Equipment (FDA 89-8221) From Food and Drug Administration (FDA) 🇺🇸 Guidance document providing clarification on radiation control regulations for diagnostic X-ray equipment by FDA (89-8221). 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 February 9, 2019 Other (Public Domain) 0 reuses 0 favorites
Clarifications of UDI related responsibilities in relation to article 16 From European Commission 🇪🇺 This document provides clarifications on UDI responsibilities in relation to article 16. 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 September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-31950. The Food and Drug Administration (FDA) is issuing this final rule to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under 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 9, 2017 Other (Public Domain) 0 reuses 0 favorites
Neurological Devices; Reclassification of Cranial Electrotherapy Stimulator Intended To Treat Insomnia and/or Anxiety; Effective Date of Requirement for Premarket Approval for Cranial Electrotherapy Stimulator Intended To Treat Depression From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-01173. The Food and Drug Administration (FDA) is issuing a proposed administrative order to reclassify the cranial electrotherapy stimulator (CES) devices intended to treat insomnia and/or anxiety, a preamendments class III device, into class II (special controls) and subject… 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 22, 2016 Other (Public Domain) 0 reuses 0 favorites
Clarification of the Term "Legal Entity" for MDSAP Recognition Purposes From International Medical Device Regulators Forum (IMDRF) 🌍 Information document IMDRF/MDSAP WG/N29FINAL:2015. 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 October 2, 2015 Other (Public Domain) 0 reuses 0 favorites
Clarification of When Products Made or Derived From Tobacco Are Regulated as Drugs, Devices, or Combination Products; Amendments to Regulations Regarding “Intended Uses” From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-24313. The Food and Drug Administration (FDA) is proposing regulations to describe the circumstances in which a product made or derived from tobacco that is intended for human consumption will be subject to regulation as a drug, device, or a combination product under 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 September 25, 2015 Other (Public Domain) 0 reuses 0 favorites
Office of the State Food and Drug Administration on further clarification of customized denture raw materials and product standards for the implementation of the requirements of the notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2012-10244 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 9, 2012 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Neurological Devices; Clarification of Classification for Human Dura Mater; Technical Amendment From Food and Drug Administration (FDA) 🇺🇸 Document number 2011-15817. The Food and Drug Administration (FDA) is amending the device regulations to clarify the applicability of the device classification for human dura mater. This action is being taken to improve the accuracy of the regulations. 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 24, 2011 Other (Public Domain) 0 reuses 0 favorites
Notice on Clarification of the Management Categories of Dental Products, including Calcium Hydroxide Paste From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2010-10332 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 September 7, 2010 Other (Public Domain) 0 reuses 0 favorites
Notice of Clarification of Management Categories for Bone Cement Cannula Components and Vertebral Body Expansion (Forming) Devices From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2010-10121 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 6, 2010 Other (Public Domain) 0 reuses 0 favorites