Clinical investigation authorization related to noninvasive Class I or Class IIa or IIb medical devices not bearing CE marking for intended use From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Online forms and services 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 8, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Authorization for clinical investigation of class IIa or IIb invasive or class III medical devices not bearing CE marking for intended use From Ministry of Health (Italy) (MDS) 🇮🇹 Medical devices - Online forms and services 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 8, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Appendix A of the MDCG 2024-5 From European Commission 🇪🇺 This document is Appendix A of the MDCG 2024-5, focusing on topics related to clinical investigation and evaluation in the medical device industry. 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 April 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746 From European Commission 🇪🇺 Document discusses safety reporting in performance studies of in vitro diagnostic medical devices under Regulation (EU) 2017/746. 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 9, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Clinical Investigation Plan Synopsis Template From European Commission 🇪🇺 A template for creating a synopsis of a clinical investigation plan, focusing on topics related to clinical investigation and evaluation. 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 March 12, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes From International Medical Device Regulators Forum (IMDRF) 🌍 Technical document: IMDRF/AE WG/N43FINAL:2020 (Edition 4) - Annexes and release notes updated annually Current release: IMDRF/AE WG/N43FINAL:2024 Updated Annexes 20 April 2024; Annex A_1 – updated 9 May 2024 (refer release notes for details) 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 7, 2024 Other (Public Domain) 0 reuses 0 favorites
Guideline for the preparation of Technical Master Files for blood, blood components and haematopoietic progenitor cells From Therapeutic Goods Administration (TGA) 🇦🇺 Guide for manufacturers in the development of Technical Master Files relevant to blood, blood components and haematopoietic progenitor cells. 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 25, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Medical devices: software applications (apps) From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Information on when software applications are considered to be a medical device and how they are regulated. 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 1, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
State Drug Administration Comprehensive Department on the issuance of "medical device business quality management standard appendix: specializing in the provision of medical device transportation and storage services of the enterprise quality management on-site inspection guidelines" notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2023-10001 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 March 10, 2024 Other (Public Domain) 0 reuses 0 favorites
ARGB Appendix 5 - Guidance on TGO 85 From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance is no longer in use and has been replaced by ARGB Appendix 13 - Guidance on TGO 109: Standards for Biologicals-General and Specific 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 December 13, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Appendix: Clinical investigation summary safety report form From European Commission 🇪🇺 This document is an appendix that provides a summary safety report form for clinical investigations and evaluations. 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
The status of Appendixes E-I of IMDRF N48 under the EU regulatory framework for medical devices From European Commission 🇪🇺 This document discusses the status of IMDRF N48 Appendixes E-I under the EU regulatory framework for medical devices, focusing on the Unique Device Identifier (UDI). 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 for 'specials' manufacturers From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers. 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 February 25, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Maintenance of IMDRF AE Terminologies From International Medical Device Regulators Forum (IMDRF) 🌍 Information document IMDRF/AE WG/N44FINAL:2020 (Edition 3). 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 April 20, 2020 Other (Public Domain) 0 reuses 0 favorites
Guidance Document: Guidance for the Labelling of Medical Devices, not including in vitro diagnostic devices - Appendices for the Labelling of Soft, Decorative, Contact Lenses and Menstrual Tampons From Health Canada 🇨🇦 2004 Health Canada guidance document 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 20, 2015 Open Government License 2.0 (Canada) 0 reuses 0 favorites
ARGB Appendix 9 - Guidance on TGO 87 From Therapeutic Goods Administration (TGA) 🇦🇺 Labelling Order. This guidance is no longer in use and has been replaced by ARGB Appendix 11 - Guidance on TGO 107: Standard for Biologicals – Labelling 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 July 14, 2011 Other (Non-Commercial) 0 reuses 0 favorites
ARGB Appendix 8 - Guidance on TGO 86 From Therapeutic Goods Administration (TGA) 🇦🇺 Standards for human skin. This guidance is no longer in use and has been replaced by ARGB Appendix 13 - Guidance on TGO 109: Standards for Biologicals-General and Specific 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 July 14, 2011 Other (Non-Commercial) 0 reuses 0 favorites
ARGB Appendix 7 - Guidance on TGO 84 From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance is no longer in use and has been replaced by ARGB Appendix 13 - Guidance on TGO 109: Standards for Biologicals-General and Specific 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 July 14, 2011 Other (Non-Commercial) 0 reuses 0 favorites
ARGB Appendix 6 - Guidance on TGO 83 From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance is no longer in use and has been replaced by ARGB Appendix 13 - Guidance on TGO 109: Standards for Biologicals-General and Specific 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 July 14, 2011 Other (Non-Commercial) 0 reuses 0 favorites
ARGB Appendix 11 - Risk management From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance outlining the approach that should be taken to risk management as applicable to biologicals. 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 14, 2011 Other (Non-Commercial) 0 reuses 0 favorites