Information on specific medical devices From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇠Get details about specific medical devices, including a list of FSCAs. 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 August 13, 2024 Other (Non-Commercial) 0 reuses 0 favorites
ICH guideline Q3D (R2) on elemental impurities From Therapeutic Goods Administration (TGA) 🇦🇺 We have adopted this International Scientific Guideline - ICH Q3D (R2); EMA/CHMP/ICH/353369/2013 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
Submissions received: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices From Therapeutic Goods Administration (TGA) 🇦🇺 The TGA thanks respondents who provided a submission in response to the public consultation paper 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices From Therapeutic Goods Administration (TGA) 🇦🇺 Regulation Impact Statement in support of proposed reforms around personalised 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 June 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 862 Clinical Chemistry and Clinical Toxicology Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H - Medical Devices - Part 862 Clinical Chemistry and Clinical Toxicology 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 February 5, 2024 Other (Public Domain) 0 reuses 0 favorites
Personalised medical devices (including 3D-printed devices) From Therapeutic Goods Administration (TGA) 🇦🇺 Information and examples to help you understand the regulatory framework for personalised medical 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 December 15, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Submissions received: Proposed regulatory changes related to personalised and 3D printed medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Submissions received on the Proposed regulatory changes related to personalised and 3D printed medical devices have been published 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 12, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Manufacturing medical devices for COVID-19 including 3-D printing From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance to assist manufacturers of medical devices and their component parts with meeting their regulatory obligations 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 28, 2021 Other (Non-Commercial) 0 reuses 0 favorites
3-D printing (additive manufacturing) of medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Information for manufacturers to assist them with addressing risks and meeting the Australian regulatory requirements for medical 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 July 30, 2020 Other (Non-Commercial) 0 reuses 0 favorites
3D printing (additive manufacturing) of medical devices or component parts during the coronavirus (COVID-19) pandemic From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The requirements for 3D printed products will depend on whether they are classed as medical devices, personal protective equipment (PPE) or both. 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 4, 2020 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Conformity assessment procedures for 3D printing and 3D printed products to be used in a medical context for COVID-19 From European Commission 🇪🇺 This document discusses conformity assessment procedures for 3D printing and products used in medical context during 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 on Patient-matched Medical Devices manufactured using 3D printers From Ministry of Food and Drug Safety (MFDS) 🇰🇷 Guidance on Patient-matched Medical Devices manufactured using 3D printers (published on December 10th, 2015) 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 26, 2018 Other (Public Domain) 0 reuses 0 favorites
Decree no. 2009-482 of April 28, 2009 on the conditions for marketing medical devices From Ministry of Labor, Health and Solidarity (MTSS) 🇫🇷 Document NOR : SJSP0828003D – Décret n° 2009-482 du 28 avril 2009 relatif aux conditions de mise sur le marché des dispositifs médicaux 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, 2009 Other (Public Domain) 0 reuses 0 favorites
REGULATORY GUIDELINE FOR 3D-PRINTED MEDICAL DEVICES From Health Sciences Authority (HSA) 🇸🇬 Document providing regulatory guidelines for 3D-printed medical devices, focusing on product-specific regulations. 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 January 3, 1900 Other (Public Domain) 0 reuses 0 favorites