21 CFR Chapter I Subchapter H – Medical Devices – Part 866 Immunology and Microbiology Devices From Food and Drug Administration (FDA) 🇺🇸 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
In vitro diagnostic medical devices - Performance studies vigilance From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Procedure In vitro diagnostic medical devices - Vigilance of performance studies 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 24, 2024 Other (Non-Commercial) 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
Draft guidance on how to interpret ‘significant change’ of a medical device: Overview From Health Canada 🇨🇦 This guidance document has been updated to expand on the definition of “significant change” in the Medical Devices Regulations (regulations). This will help you determine whether a change proposed to a Class III or IV medical device is significant. 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 7, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Advertising guidance for businesses involved with intravenous (IV) vitamin and related therapies From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance assists providers of IV drips to understand how to comply with the therapeutic goods advertising requirements in Australia. 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 6, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Guidance on clinical evidence requirements for medical devices: Overview From Health Canada 🇨🇦 This document provides guidance to manufacturers of Class III and IV medical devices and regulatory representatives on the clinical evidence 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 April 17, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guidance on how to complete the application for a new medical device licence: Overview From Health Canada 🇨🇦 This document describes how to complete an application for a new medical device licence for class II, III and IV medical devices, including payment of applicable fees. 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 27, 2021 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Commission Delegated Directive (EU) 2021/1978 of 11 August 2021 amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices (Text with EEA relevance) From European Parliament 🇪🇺 Commission Delegated Directive (EU) 2021/1978 amends Directive 2011/65/EU regarding the use of certain phthalates in spare parts 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 August 11, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for the use of bis(2-ethylhexyl) phthalate (DEHP), butyl benzyl phthalate (BBP), dibutyl phthalate (DBP) and diisobutyl phthalate (DIBP) in spare parts recovered from and used for the repair or refurbishment of medical devices From European Parliament 🇪🇺 This document is a delegated directive that amends Annex IV to Directive 2011/65/EU regarding the use of certain phthalates in medical device spare parts. 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 11, 2021 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Delegated Directive (EU) 2020/366 of 17 December 2019 amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabiliser in polyvinyl chloride used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases (Text with EEA relevance) From European Parliament 🇪🇺 Commission Delegated Directive (EU) 2020/366 amends Annex IV to Directive 2011/65/EU, allowing lead exemption in certain 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 17, 2019 Creative Commons Attribution 4.0 0 reuses 0 favorites
COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabiliser in polyvinyl chloride used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases From European Parliament 🇪🇺 This document is a draft delegated directive that aims to amend the use of lead in certain medical devices for blood and body fluid analysis. 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 December 17, 2019 Creative Commons Attribution 4.0 0 reuses 0 favorites
COMMISSION DELEGATED DIRECTIVE (EU) .../… amending, for the purposes of adapting to scientific and technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabiliser in polyvinyl chloride used in certain in-vitro diagnostic medical devices for the analysis of blood and other body fluids and body gases From European Parliament 🇪🇺 This document is a draft delegated directive that aims to amend the use of lead in certain medical devices for blood and body fluid analysis. 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 30, 2019 Creative Commons Attribution 4.0 0 reuses 0 favorites
Provision No. 9688/2019 From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷 Registration, modifications, revalidation, transfer and cancellation of Class I, II, III and IV Medical Products, national and imported. B.O. December 02, 2019. 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 1, 2019 Creative Commons Attribution 4.0 0 reuses 0 favorites
Provision 5706/2017 From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷 This provision shall apply to applications for registration, modification and revalidation of Class I and II medical products and applications for modification of some characteristic data of Class III and IV medical products authorized by this Administration. B.O. June 2, 2017. 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 1, 2017 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
Commission Delegated Directive (EU) 2016/585 of 12 February 2016 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead, cadmium, hexavalent chromium, and polybrominated diphenyl ethers (PBDE) in spare parts recovered from and used for the repair or refurbishment of medical devices or electron microscopes (Text with EEA relevance) From European Parliament 🇪🇺 Commission Delegated Directive (EU) 2016/585 amends Annex IV to Directive 2011/65/EU regarding exemptions for certain substances in spare parts 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 February 12, 2016 Creative Commons Attribution 4.0 0 reuses 0 favorites
Adrenaline auto-injectors - referral From European Medicines Agency (EMA) 🇪🇺 Information on the referral process for adrenaline auto-injectors. Metadata quality: Metadata quality: Data description empty Files documented 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 26, 2015 Other (Public Domain) 0 reuses 0 favorites
Commission Delegated Directive (EU) 2015/573 of 30 January 2015 amending, for the purposes of adapting to technical progress, Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in polyvinyl chloride sensors in in-vitro diagnostic medical devices Text with EEA relevance From European Parliament 🇪🇺 Commission Delegated Directive (EU) 2015/573 amends Directive 2011/65/EU by exempting lead in PVC sensors in 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 January 30, 2015 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Delegated Directive 2014/15/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead, cadmium and hexavalent chromium in reused spare parts, recovered from medical devices placed on the market before 22 July 2014 and used in category 8 equipment placed on the market before 22 July 2021 , provided that reuse takes place in auditable closed-loop business-to-business return systems, and that the reuse of parts is notified to the consumer Text with EEA relevance From European Parliament 🇪🇺 Commission Delegated Directive 2014/15/EU amends Directive 2011/65/EU regarding exemptions for lead, cadmium, and hexavalent chromium in reused spare parts from 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 October 18, 2013 Creative Commons Attribution 4.0 0 reuses 0 favorites
Commission Delegated Directive 2014/13/EU of 18 October 2013 amending, for the purposes of adapting to technical progress, the Annex IV to Directive 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead in solders on populated printed circuit boards used in Directive 93/42/EEC class IIa and IIb mobile medical devices other than portable emergency defibrillators Text with EEA relevance From European Parliament 🇪🇺 Commission Delegated Directive 2014/13/EU amends Annex IV to Directive 2011/65/EU regarding lead exemption in 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 October 18, 2013 Creative Commons Attribution 4.0 0 reuses 0 favorites