Technical Reference Group for Software as a Medical Device (SaMD) and Artificial Intelligence (AI) From Therapeutic Goods Administration (TGA) 🇦🇺 Information on the role and membership of the Technical Reference Group for SaMD and AI. 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 15, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Regulatory changes for software based medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance provides a summary of changes to the regulation of software based medical devices (including software as a 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 July 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Submissions received: Regulation of software, including Software as a Medical Device (SaMD) From Therapeutic Goods Administration (TGA) 🇦🇺 Submissions received: Regulation of software, including Software as a Medical Device (SaMD) 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
Software and artificial intelligence (AI) as a medical device From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD). 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 13, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
GL-04-R3 Regulatory Guidelines for Software Medical Devices - A Life Cycle Approach (2024 Mar) PUB From Health Sciences Authority (HSA) 🇸🇬 Document focusing on SaMD specific regulatory guidelines. 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 1, 2024 Other (Public Domain) 0 reuses 0 favorites
Reporting adverse incidents involving Software as a Medical Device under the vigilance system From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Information for manufacturers of Software as a Medical Device, detailing events that may cause indirect harm and are therefore reportable. 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 15, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Crafting an intended purpose in the context of Software as a Medical Device (SaMD) From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory 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 March 22, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Guidance Document: Software as a Medical Device (SaMD): Classification Examples From Health Canada 🇨🇦 This document is intended to clarify how Software as a Medical Device (SaMD) fits into Health Canada’s regulatory framework for medical devices, based on current interpretation of the definitions of “device” and “medical device” in the Act and Regulations. 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 15, 2022 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guidelines-Risk-Classification-SAMD-CDSS (2022 Apr) PUB From Health Sciences Authority (HSA) 🇸🇬 Provides regulatory guidelines on product classification, specifically for SAMD and CDSS. 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 April 1, 2022 Other (Public Domain) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 657 of 24/03/2022 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Provides for the regularization of software as a medical device (SaMD) 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 March 31, 2022 Other (Public Domain) 0 reuses 0 favorites
Software and applications From National Institute of Pharmacy and Nutrition (OGYÉI) 🇭🇺 A guide discussing considerations related to medical device software and SaMD. 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 November 9, 2021 Other (Public Domain) 0 reuses 0 favorites
Software as a Medical Device (SAMD): Clinical Evaluation: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document is a guidance for industry and FDA staff on the clinical evaluation of Software as a Medical Device (SAMD). 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 March 18, 2021 Other (Public Domain) 0 reuses 0 favorites
Is your software a Medical Device? From European Commission 🇪🇺 Is your software a Medical Device?" - A document discussing the classification of software as a medical device, focusing on new technologies. 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 Document: Software as a Medical Device (SaMD): Definition and Classification From Health Canada 🇨🇦 This document is intended to clarify how Software as a Medical Device (SaMD) fits into Health Canada’s regulatory framework for medical devices, based on current interpretation of the definitions of “device” and “medical device” in the Act and Regulations. 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 18, 2020 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guidance on Software as a Medical Device From Saudi Food and Drug Authority (SFDA) 🇸🇦 Guidance on the classification and regulation of medical software. 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 April 8, 2018 Other (Public Domain) 0 reuses 0 favorites
Software as a Medical Device (SaMD): Clinical Evaluation From International Medical Device Regulators Forum (IMDRF) 🌍 Technical document: IMDRF/SaMD WG/N41FINAL:2017 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 September 21, 2017 Other (Public Domain) 0 reuses 0 favorites
Software as a Medical Device (SaMD): Application of Quality Management System From International Medical Device Regulators Forum (IMDRF) 🌍 Technical document: IMDRF/SaMD WG/N23FINAL:2015 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 October 2, 2015 Other (Public Domain) 0 reuses 0 favorites
Software as a Medical Device: Possible Framework for Risk Categorization and Corresponding Considerations From International Medical Device Regulators Forum (IMDRF) 🌍 Technical document: IMDRF/SaMD WG/N12FINAL:2014 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 September 18, 2014 Other (Public Domain) 0 reuses 0 favorites
Software as a Medical Device (SaMD): Key Definitions From International Medical Device Regulators Forum (IMDRF) 🌍 Technical document: IMDRF/SaMD WG/N10FINAL:2013 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 December 18, 2013 Other (Public Domain) 0 reuses 0 favorites
The 6th Term Science Board (FY2022, FY2023) From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵 A document discussing the 6th Term Science Board for FY2022 and FY2023, focusing on Regulatory Science, The Science Board, and Standard Development. 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 10, 2024 Other (Public Domain) 0 reuses 0 favorites