21 CFR Chapter I Subchapter H β Medical Devices β Part 876 Gastroenterology-Urology Devices From Food and Drug Administration (FDA) πΊπΈ Regulation on Gastroenterology-Urology Devices under 21 CFR Chapter I Subchapter H - Medical Devices, Part 876. 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 2 days ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 886 Ophthalmic Devices From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 886 Ophthalmic 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 870 Cardiovascular Devices From Food and Drug Administration (FDA) πΊπΈ A regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 870 Cardiovascular 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 864 Hematology and Pathology Devices From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 864 Hematology and Pathology 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 882 Neurological Devices From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 882 Neurological 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Medical devices reforms: software regulation From Therapeutic Goods Administration (TGA) π¦πΊ New classifications clarify regulation of software-based 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 1 month ago Other (Non-Commercial) 0 reuses 0 favorites
Technical Reference Group for Software as a Medical Device (SaMD) and Artificial Intelligence (AI) From Therapeutic Goods Administration (TGA) π¦πΊ 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
Information on specific medical devices From Swiss Agency for Therapeutic Products (Swissmedic) π¨π 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
Regulation of software based medical devices From Therapeutic Goods Administration (TGA) π¦πΊ Software based medical devices are medical devices that incorporate software or are software. 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 26, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Software and mobile healthcare applications From National Agency for the Safety of Medicines and Health Products (ANSM) π«π· Reference document Software and mobile healthcare applications in your application process 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 24, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Principle 12: Medical devices connected to or equipped with an energy source From Therapeutic Goods Administration (TGA) π¦πΊ Principle 12.1 provides general requirements for programmed or programmable medical devices or software that is 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 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Impact of new European regulations on software classification From National Agency for the Safety of Medicines and Health Products (ANSM) π«π· Reference document Impact of new European regulations on the classification of software in your application process 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
Regulatory changes for software based medical devices From Therapeutic Goods Administration (TGA) π¦πΊ 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) π¦πΊ 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) π¬π§ 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
21 CFR Chapter I Subchapter H β Medical Devices β Part 801 Labeling From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 801 Labeling". 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 June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
Artificial Intelligence (AI) and medical device software From Therapeutic Goods Administration (TGA) π¦πΊ Information for software manufacturers when AI is considered a medical device, and how we regulate AI 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 May 9, 2024 Other (Non-Commercial) 0 reuses 0 favorites
UDI Webinars From Therapeutic Goods Administration (TGA) π¦πΊ UDI webinars cover a range of topics including introductory UDI information, adoption in healthcare and software support for UDI. 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 7, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Software as in vitro diagnostic medical devices (IVDs) From Therapeutic Goods Administration (TGA) π¦πΊ Find out when software is classified as an in vitro medical device and how it is regulated. 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 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Actual and potential harm caused by medical software From Therapeutic Goods Administration (TGA) π¦πΊ A rapid literature review of safety and performance issues 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 5, 2024 Other (Non-Commercial) 0 reuses 0 favorites