ZL203_00_002e_WL Guidance document No marketing / interruption of distribution From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 This document provides guidance on the marketing and distribution of ZL203_00_002e_WL without any interruptions. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 809 In Vitro Diagnostic Products for Human Use From Food and Drug Administration (FDA) 🇺🇸 Regulation on in vitro diagnostic products for human use under 21 CFR Chapter I Subchapter H - Medical Devices - Part 809. 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 8, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 820 Quality System Regulation From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 820 Quality System Regulation". 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
Distribution records From Therapeutic Goods Administration (TGA) 🇦🇺 Information on the requirement for sponsors to keep distribution records 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 May 23, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Products restricted in distribution From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 The document outlines medical devices subject to distribution restrictions. 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 February 14, 2024 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
GN-33 R2 Guidance on the Application of Singapore Standard GDPMDS (2023 Sep) PUB From Health Sciences Authority (HSA) 🇸🇬 Provides guidance on Good Distribution Practice for Medical Devices (GDPMDS). 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 1, 2023 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 810 Medical Device Recall Authority From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 810 Medical Device Recall Authority". 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
GN-06-R3 Guidance on Distribution Records(2022 Nov)_PUB From Health Sciences Authority (HSA) 🇸🇬 Provides insights on Good Distribution Practice for Medical Devices (GDPMDS). 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 1, 2022 Other (Public Domain) 0 reuses 0 favorites
Labels for COVID-19 treatments From Therapeutic Goods Administration (TGA) 🇦🇺 To enable timely distribution of COVID-19 treatments, international labels may be used during initial supply in Australia. 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 17, 2022 Other (Non-Commercial) 0 reuses 0 favorites
MDR Newsletter 1/2021: The impact of BREXIT on the distribution of medical devices From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter discussing the impact of BREXIT on the distribution of medical devices in the first issue of 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 March 2, 2022 Other (Public Domain) 0 reuses 0 favorites
Distribution of rapid antigen tests under the workplace screening initiative: Interim enforcement approach From Health Canada 🇨🇦 Information for importing and distributing COVID-19 rapid antigen tests as part of the COVID-19 workplace screening initiative 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 14, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
CPG Sec. 300.600 Commercial Distribution with Regard to Premarket Notification (Section 510(k)) From Food and Drug Administration (FDA) 🇺🇸 CPG Sec. 300.600 outlines regulations for commercial distribution and premarket notification (Section 510(k)) in the CPG. 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 3, 2021 Other (Public Domain) 0 reuses 0 favorites
Licensing and Regulatory requirements for the manufacture and distribution of medical and respirator masks during Covid-19 From South African Health Products Regulatory Authority (SAHPRA) 🇿🇦 Document Number MD025 - 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 September 22, 2020 Other (Public Domain) 0 reuses 0 favorites
Banned Devices; Electrical Stimulation Devices for Self-Injurious or Aggressive Behavior From Food and Drug Administration (FDA) 🇺🇸 Document number 2020-04328. The Food and Drug Administration (FDA, the Agency, or we) is finalizing a ban on electrical stimulation devices (ESDs) for self- injurious or aggressive behavior. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury… 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 6, 2020 Other (Public Domain) 0 reuses 0 favorites
Distribution of In Vitro Diagnostic Products Labeled for Research Use Only or Investigational Use Only: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on the distribution of in vitro diagnostic products labeled for research or investigational use only. 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
Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection From Food and Drug Administration (FDA) 🇺🇸 Document number 2019-06026. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to classify in vitro diagnostic devices for Bacillus species (spp.) detection into class II (special controls) and to continue to require a premarket notification (510(k)) to provide a… 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 1, 2019 Other (Public Domain) 0 reuses 0 favorites
Banned Devices; Proposal To Ban Electrical Stimulation Devices Used To Treat Self-Injurious or Aggressive Behavior From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-09433. The Food and Drug Administration (FDA or we) is proposing to ban electrical stimulation devices used to treat aggressive or self- injurious behavior. FDA has determined that these devices present an unreasonable and substantial risk of illness or injury that cannot be… 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 25, 2016 Other (Public Domain) 0 reuses 0 favorites
Unique Device Identification System; Editorial Provisions; Technical Amendment From Food and Drug Administration (FDA) 🇺🇸 Document number 2016-04707. The Food and Drug Administration (FDA or Agency) is amending the Unique Device Identification (UDI) System regulation to make editorial changes. This technical amendment updates the email address associated with FDA's UDI system, which allows FDA to obtain information… 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 4, 2016 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Classification of In Vitro Diagnostic Devices for Bacillus Species Detection From Food and Drug Administration (FDA) 🇺🇸 Document number 2015-29275. The Food and Drug Administration (FDA) is re-proposing to classify in vitro diagnostic devices for Bacillus species (spp.) detection into class II (special controls) after considering, among other information, the recommendations of the Microbiology Devices Advisory… 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 17, 2015 Other (Public Domain) 0 reuses 0 favorites