21 CFR Chapter I Subchapter H โ Medical Devices โ Part 866 Immunology and Microbiology Devices From Food and Drug Administration (FDA) ๐บ๐ธ Regulation on Immunology and Microbiology Devices under 21 CFR Chapter I Subchapter H - Medical Devices, Part 866. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 88.88888888888889/100 Updated 1 day ago Other (Public Domain) 0 reuses 0 favorites
Mpox (monkeypox) From Health Canada ๐จ๐ฆ Links to mpox (monkeypox) information including Canadaโs current situation, symptoms, prevention, risks, vaccines, information for health professionals, technical documents. 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 3 days ago Open Government License 2.0 (Canada) 0 reuses 0 favorites
Nasal rinsing devices and the risk of infection From Health Canada ๐จ๐ฆ Learn about the different types of nasal rinsing devices and the increased risk of infection if theyโre used incorrectly. 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 1 week ago Open Government License 2.0 (Canada) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 870 Cardiovascular Devices From Food and Drug Administration (FDA) ๐บ๐ธ A regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 870 Cardiovascular 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
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document provides guidance on the use of ISO 10993-1 for evaluating and testing medical devices within a risk management process. 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Principle 8: Infection and microbial contamination From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Medical devices must be designed and produced in a way that removes or reduces infection risks. They can pose infection risks to patients, users, or others. 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 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Principle 9: Construction and environmental properties From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Principle 9 requires medical devices manufacturers to consider safety when using more than one medical device and minimising the risks associated. 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 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical device safety and use From Health Canada ๐จ๐ฆ Medical device safety: From bandages to pacemakers, Health Canada ensures benefits outweigh risks, monitoring post-market use. 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 30, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guiding principles: Predetermined change control plans for machine learning-enabled medical devices From Health Canada ๐จ๐ฆ FDA, Health Canada and MHRA jointly identified 5 guiding principles for predetermined change control plans, drawing upon GMLP guiding principles, particularly stating that deployed models are monitored for performance and re-training risks are managed. 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 29, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
ICH M7(R2) Guideline on assessment and control of DNA reactive (mutagenic) impurities in pharmaceuticals to limit potential carcinogenic risk From Therapeutic Goods Administration (TGA) ๐ฆ๐บ We have adopted this International Scientific Guideline - ICH M7 (R2); EMA/CHMP/ICH/83812/2013 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 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure From Therapeutic Goods Administration (TGA) ๐ฆ๐บ How the TGA assesses the safety of materials derived from human and other animal species, naturally susceptible to TSE, that are used in the manufacture 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 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Manage a recall From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Recall procedures to be followed when there is a potential health risk. 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
Purpose and Content of Use-Related Risk Analyses for Drugs, Biological Products, and Combination Products From Food and Drug Administration (FDA) ๐บ๐ธ Guidance document outlining the purpose and content of use-related risk analyses for drugs, biological products, and combination products. 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 July 9, 2024 Other (Public Domain) 0 reuses 0 favorites
Clinical performance requirements and risk mitigation strategies for HIV tests From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Guidance for manufacturers and sponsors of HIV tests on meeting regulatory requirements and expectations. 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, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Five questions to ask your health professional before you get a medical implant From Therapeutic Goods Administration (TGA) ๐ฆ๐บ It's important that you discuss the risks and benefits of all options available to you with your health professional before making a decision. 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
SCHEER - Call for external experts for the SCHEER WG on risks for the health associated to the use of brain stimulators not having an intended medical purpose described in the group 6 of Annex XVI to Regulation (EU) 2017/745 From European Commission ๐ช๐บ Status: Open Opening date: 19 June 2024 Deadline: 31 August 2024, 23:59 (CEST) 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 19, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Alerts - Medical Devices From Spanish Agency for Medicines and Medical Devices (AEMPS) ๐ช๐ธ Last updated: December 20, 2018 The purpose of medical device alerts is to bring to the attention of healthcare professionals and/or users of such devices, the potential risks that may arise from their use and the measures to be taken to minimize or eliminate them.... 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 10, 2024 Other (Public Domain) 0 reuses 0 favorites
National register of breast prosthetic implants From Ministry of Health (Italy) (MDS) ๐ฎ๐น 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,โฆ 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
Australiaโs breast implant risk management framework From Therapeutic Goods Administration (TGA) ๐ฆ๐บ This framework outlines our processes to identify and manage risk relating to breast implants. 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 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Risks From Therapeutic Goods Administration (TGA) ๐ฆ๐บ No medical device is 100% safe. Learn about the risks associated with breast implants. 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 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites