List of Ventilators, CPAP, and BiPAP devices containing PE-PUR foam material in the breathing gas pathway From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The TGA has identified additional devices (other than those supplied by Philips Electronics Australia Ltd) that contain PE-PUR foam material for sound abatement purpose in the breathing gas pathway. 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 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Exporting a ventilator From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Information for sponsors and manufacturers about pathways for exporting a ventilator from Australia. 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 10, 2024 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 868 Anesthesiology Devices From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 868 Anesthesiology 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 May 21, 2024 Other (Public Domain) 0 reuses 0 favorites
COVID-19 health product industry From Health Canada ๐จ๐ฆ Links to COVID-19-related information for health product manufacturers and distributors of diagnostic tests, ventilators, hand sanitizers and disinfectants. 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 15, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Post-market review of ventilators, CPAP and BiPAP devices From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The TGA is undertaking a post-market review of ventilators included in the Australian Register of Therapeutic Goods. 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 31, 2023 Other (Non-Commercial) 0 reuses 0 favorites
List of ventilators, CPAP, and BiPAP devices unaffected by foam material From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The TGA is reviewing all ventilators, CPAP, and BiPAP devices in the ARTG to clarify what devices incorporate sound abatement features. 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 10, 2023 Other (Non-Commercial) 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) ๐ฟ๐ฆ 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
Renewal of Section 21 Authorisation for use of unregistered rapidly developed non-invasive ventilators From South African Health Products Regulatory Authority (SAHPRA) ๐ฟ๐ฆ Document Number MD029 - 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 June 24, 2021 Other (Public Domain) 0 reuses 0 favorites
Guidance Rapidly developed ventilator From South African Health Products Regulatory Authority (SAHPRA) ๐ฟ๐ฆ Document Number MD010 - 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 May 13, 2020 Other (Public Domain) 0 reuses 0 favorites
Specification for ventilators to be used in UK hospitals during the coronavirus (COVID-19) outbreak From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง This guidance sets out the clinical requirements based on the consensus of what is โminimally acceptableโ performance in the opinion of the anaesthesia and intensive care medicine professionals and medical device regulators. 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 28, 2020 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Regulatory requirements for ventilators and related accessories From European Commission ๐ช๐บ This document discusses regulatory requirements for ventilators and related accessories, with a focus on COVID-19. 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
Guidance for Oxygen Conserving Device 510(k) Review 73 BZD 868.5905 Non-continuous Ventilator Class II From Food and Drug Administration (FDA) ๐บ๐ธ This document is a guidance document for the review of a non-continuous ventilator class II device for oxygen conservation. 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 17, 2020 Other (Public Domain) 0 reuses 0 favorites
Notice on Strengthening the Supervision of Medical Protective Masks, Medical Protective Clothing, Ventilators and Other Medical Devices From National Medical Products Administration (NMPA) ๐จ๐ณ FGWJ-2009-10355 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 20, 2009 Other (Public Domain) 0 reuses 0 favorites
Notice on the implementation of YY0042-2007 "High Frequency Jet Ventilator" and other 46 medical device industry standards From National Medical Products Administration (NMPA) ๐จ๐ณ FGWJ-2007-10191 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 January 31, 2007 Other (Public Domain) 0 reuses 0 favorites
Circular on the Announcement of the Results of Quality Supervision and Sampling Tests of Ventilators, High Frequency Surgical Equipment and Biochemical Analyzers in 2003 From National Medical Products Administration (NMPA) ๐จ๐ณ FGWJ-2004-10171 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
Article 41/42 Criteria and Review Point (Others) From Pharmaceuticals and Medical Devices Agency (PMDA) ๐ฏ๐ต A regulation document outlining criteria and review points for Article 41/42, categorized under "Others. 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 August 15, 2024 Other (Public Domain) 0 reuses 0 favorites
PMDA Medical Safety Information From Pharmaceuticals and Medical Devices Agency (PMDA) ๐ฏ๐ต Information 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 on May 10, 2024 Other (Public Domain) 0 reuses 0 favorites