Report an adverse event or problem (industry) From Therapeutic Goods Administration (TGA) 🇦🇺 As the sponsor of a medicine or a medical device in Australia, you have a responsibility to report adverse events. 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
TGA-NATA MoU relating to the regulation of in-house IVDs From Therapeutic Goods Administration (TGA) 🇦🇺 Describers the interaction, role and responsibilities of the TGA and NATA in relation to the regulation of in-house IVDs 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 25, 2024 Other (Non-Commercial) 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 822 Postmarket Surveillance From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 822 Postmarket Surveillance". 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
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
Post market responsibilities for manufacturers and sponsors of medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Start here to learn the basics of post market requirements 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 30, 2024 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 812 Investigational Device Exemptions From Food and Drug Administration (FDA) 🇺🇸 Regulation on Investigational Device Exemptions under 21 CFR Chapter I Subchapter H - Medical Devices - Part 812. 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 January 23, 2024 Other (Public Domain) 0 reuses 0 favorites
Roles and responsibilities for clinical trial safety reporting of significant safety issues and urgent safety measures From Therapeutic Goods Administration (TGA) 🇦🇺 Summarises the roles and responsibilities of key stakeholders in clinical trial safety reporting of significant safety issues (SSIs) and urgent safety measures (USMs). 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, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Manufacture a medical device From Therapeutic Goods Administration (TGA) 🇦🇺 Regulatory responsibilities and expectations for manufacturers of medical devices, including in vitro diagnostics (IVDs). 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 19, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Quality management system audits and certification guidance From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance for medical devices manufacturers on how we conduct Quality Management System (QMS) audits, roles and responsibilities for audits, aspects of conformity assessment certification and post-audit activities. 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 19, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Is your advertising for therapeutic goods compliant? From Therapeutic Goods Administration (TGA) 🇦🇺 This checklist may help you to meet your responsibility for ensuring your advertising complies with the advertising legislative requirements. 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 8, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Medical Devices Vigilance Program - Pilot From Therapeutic Goods Administration (TGA) 🇦🇺 Find out about the Medical Devices Vigilance Program (MDVP) pilot, which aims to support Australian medical device sponsors to comply with their post-market vigilance responsibilities. 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 10, 2023 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 830 Unique Device Identification From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 830 Unique Device Identification". 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 17, 2023 Other (Public Domain) 0 reuses 0 favorites
Obligations of manufacturers of custom-made devices according to the MDR From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 This document outlines the responsibilities of manufacturers of custom-made devices in compliance with the Medical Device Regulation (MDR). 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 2, 2023 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 821 Medical Device Tracking Requirements From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "Medical Device Tracking Requirements" under 21 CFR Chapter I Subchapter H. 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
CPG Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a Compliance Policy Guide (CPG) that discusses the status and responsibilities of contract sterilizers in drug and device sterilization. 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 24, 2023 Other (Public Domain) 0 reuses 0 favorites
Complying with advertising requirements From Therapeutic Goods Administration (TGA) 🇦🇺 This section informs advertisers, including manufacturers, pharmacists and health professionals, of their responsibilities when advertising 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 1, 2022 Other (Non-Commercial) 0 reuses 0 favorites
MDR Newsletter 14/2021: Information for distributors (responsibilities, obligations under MDR) From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A newsletter providing information for distributors on their responsibilities and obligations under the Medical Device Regulation (MDR) in issue 14 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
First aid kits that contain medical devices and/or medicines From Therapeutic Goods Administration (TGA) 🇦🇺 How the TGA defines first aid kits and guidance for sponsors and manufacturers on regulatory responsibilities associated with first aid kits supplied using the special conformity assessment procedure. 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 26, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Investigator Responsibilities – Safety Reporting for Investigational Drugs and Devices: Draft Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 This document is a draft guidance for industry on investigator responsibilities for safety reporting of investigational drugs and 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 September 29, 2021 Other (Public Domain) 0 reuses 0 favorites