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
Guide for Health institutions Who Manufacture and Use In-house IVDs in Ireland From Health Products Regulatory Authority (HPRA) 🇮🇪 A guidance document for health institutions in Ireland on manufacturing and using in-house in vitro diagnostics (IVDs). 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 May 24, 2024 Other (Public Domain) 0 reuses 0 favorites
Class 1-3 in-house IVDs: using the online application form From Therapeutic Goods Administration (TGA) 🇦🇺 For sponsors who are providing their notification to the TGA of their Class 1-3 in-house IVDs 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 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Regulatory requirements for in-house IVDs From Therapeutic Goods Administration (TGA) 🇦🇺 A guide to following regulatory requirements for in-house IVDs in vitro diagnostic medical devices (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 May 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guidance on the development of IVDs for in-house use From Saudi Food and Drug Authority (SFDA) 🇸🇦 A document providing guidance on the development of In Vitro Diagnostics (IVDs) for in-house use. 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 March 5, 2024 Other (Public Domain) 0 reuses 0 favorites
Australian declaration of conformity templates (IVDs) From Therapeutic Goods Administration (TGA) 🇦🇺 Templates for manufacturers to make Australian Declarations of Conformity for an in vitro diagnostic medical device. 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 February 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guidance on the health institution exemption under Article 5(5) of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 From European Commission 🇪🇺 Guidance on health institution exemption for in-house devices under EU regulations 2017/745 and 2017/746. 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
Proposal for a REGULATION OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL amending Regulation (EU) 2017/746 as regards transitional provisions for certain in vitro diagnostic medical devices and deferred application of requirements for in-house devices From European Parliament 🇪🇺 This document is a proposal to amend a regulation regarding transitional provisions for certain medical devices and deferred requirements for in-house devices. 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 14, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
Lasers Manufactured and Used In-House (Laser Notice 14) From Food and Drug Administration (FDA) 🇺🇸 A guidance document titled "Lasers Manufactured and Used In-House (Laser Notice 14)" provides information on laser manufacturing and usage. 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 January 26, 2021 Other (Public Domain) 0 reuses 0 favorites
In-house manufacture of medical devices in Great Britain From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Guidance for healthcare establishments that manufacture medical devices in-house. 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 31, 2020 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Therapeutic Goods Information (Sharing information about in-house in vitro diagnostic medical devices) Specification 2017 From Office of Parliamentary Council Australia 🇦🇺 Document F2017L00965. 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 3, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Class 4 in-house IVDs: using the online application form From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance to assist sponsors of class 4 in-house IVDs fill out the online application form in TGA Business Services. 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 September 12, 2016 Other (Non-Commercial) 0 reuses 0 favorites
In-house IVDs From Health Products Regulatory Authority (HPRA) 🇮🇪 This page provides information and supports for manufacturers of in-house in vitro diagnostic medical devices (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 May 12, 2024 Other (Public Domain) 0 reuses 0 favorites