Medical Devices From South African Health Products Regulatory Authority (SAHPRA) 🇿🇦 The medical device unit of SAHPRA regulates the licencing of medical device establishments and the registration of medical devices 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 1 week ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 864 Hematology and Pathology Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 864 Hematology and Pathology 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Medical device reforms: establishment of a Unique Device Identification system From Therapeutic Goods Administration (TGA) 🇦🇺 Strengthened patient safety through the establishment of a UDI database for medical devices. 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
Medical Devices Compliance Program Bulletin From Health Canada 🇨🇦 Information on regulatory activities, process changes and hot issues regarding medical device establishment licencing. 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 26, 2024 Open Government License 2.0 (Canada) 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 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of 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
Guidance on the Procedures for Licensing of Medical Devices and Supplies Establishments From Saudi Food and Drug Authority (SFDA) 🇸🇦 A document providing guidance on the procedures for licensing medical devices and supplies establishments. 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 January 22, 2024 Other (Public Domain) 0 reuses 0 favorites
Updates to the medical device establishment licence application (FRM-0292) and instructions From Health Canada 🇨🇦 MDEL bulletin highlighting updates to the medical device establishment licence application instructions form FRM-0292. 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 4, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guideline on Questions and Answers Licensing of Medical Device Establishments From South African Health Products Regulatory Authority (SAHPRA) 🇿🇦 Document Number SAHPGL-MD-07 - Version 3 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 November 17, 2023 Other (Public Domain) 0 reuses 0 favorites
Usage information flow From Ministry of Health (Italy) (MDS) 🇮🇹 The Decree of the Minister of Health June 11, 2010, provided for the establishment of the database for monitoring medical devices that healthcare facilities directly managed by the National Health Service purchase or make available for use. The database is fed by individual regions and also covers… 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 October 13, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Notice on the Issuance of GB 9706.1-2020 and Supporting Concurrent Standards and Specialized Standards Expert Consultation Mechanisms From National Medical Products Administration (NMPA) 🇨🇳 Notice regarding the issuance of GB 9706.1-2020 and related standards, along with the establishment of consultation mechanisms for specialized standards experts. 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 29, 2023 Other (Public Domain) 0 reuses 0 favorites
Meeting of the Executive Steering Group on Shortages of Medical Devices (MDSSG) From European Medicines Agency (EMA) 🇪🇺 Meeting of the Executive Steering Group on Shortages of Medical Devices (MDSSG). 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 25, 2023 Other (Public Domain) 0 reuses 0 favorites
State Drug Administration Comprehensive Department on agreeing to prepare for the establishment of medical device packaging standardization technology focal point of the letter From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2023-10001 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 July 24, 2023 Other (Public Domain) 0 reuses 0 favorites
What Medical Device Establishment Licence (MDEL) holders need to know about annual licence review for 2023 From Health Canada 🇨🇦 Medical Devices Establishment License bulletin outlining the annual licence review process for 2023. 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 2, 2022 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Medical Device Establishment Licence Renewal Process From South African Health Products Regulatory Authority (SAHPRA) 🇿🇦 Document Number MD031 - Version 2 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 22, 2022 Other (Public Domain) 0 reuses 0 favorites
Requirements for Licensing of Medical Devices Establishments (MDS-REQ9) From Saudi Food and Drug Authority (SFDA) 🇸🇦 Regulation: Requirements for Licensing of Medical Devices Establishments. 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 August 18, 2022 Other (Public Domain) 0 reuses 0 favorites
State Drug Administration Comprehensive Department on agreeing to prepare for the establishment of medical device reliability and maintainability standardization technology focal point of the reply letter From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2022-168 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 March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
State Drug Administration Comprehensive Department on the consent to prepare for the establishment of oral digital medical device standardization technology focal point unit of the reply letter From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2022-164 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 March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Notice on the Establishment of Medical Device Industry Standard "Recombinant Humanized Collagen" by Comprehensive Department of State Drug Administration From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2022-143 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 March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Off-label advertising and sale of COVID-19 rapid antigen tests under workplace screening initiative: Interim enforcement approach From Health Canada 🇨🇦 Medical Devices Establishment License bulletin outlining the interim enforcement approach to off-label advertising and sale of rapid antigen tests under workplace screening program 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 12, 2022 Open Government License 2.0 (Canada) 0 reuses 0 favorites