Assistive technology: definitions, examples and safe use From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Helps manufacturers and healthcare professionals understand the definition of assistive technology and the difference between medical devices and aids to daily living. 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 2 weeks ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Combined studies From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Document covers various studies, focusing on clinical trials. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Performance studies From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 This document discusses performance studies, with a focus on clinical trials. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Clinical investigations From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 This document discusses clinical investigations, with a focus on clinical trials. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Announcements From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Various announcements on clinical trials, clinical investigation etc. 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 3 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Boundary and combination products From Therapeutic Goods Administration (TGA) 🇦🇺 A guide to help sponsors figure out if their therapeutic goods are medicines, biologicals, or 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 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Recall action templates From Therapeutic Goods Administration (TGA) 🇦🇺 Templates to help you with your communications under the Uniform recall procedure for therapeutic goods (URPTG). 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 26, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Share your views: Draft guidance on how to interpret ‘significant change’ of a medical device From Health Canada 🇨🇦 Health Canada has updated the Guidance on how to interpret ‘significant change’ of a medical device. This guidance: • helps manufacturers determine when a change made to a device is significant • explains the concepts that manufacturers must apply when making this determination • provides many… 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
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
Guidance on the Review and Approval of Artificial Intelligence (AI)-based Medical Devices From Ministry of Food and Drug Safety (MFDS) 🇰🇷 This guidance applies to machine Learning-enabled medical devices, in which machine learning-based AI technology is applied to diagnose, manage, or predict diseases by analyzing medical data. They also apply to AI software configured using hardware. For example, clinical decision supporting (CDS)… 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 20, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical devices: off-label use From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 What is considered off-label use of a medical device and examples of it. 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 1, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Clinical trials From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 This document discusses clinical trials. 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 3 weeks ago Other (Non-Commercial) 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
Testimonials and endorsements in advertising From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance explains the requirements for using endorsements and testimonials in advertisements about therapeutic goods and provides examples. 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 26, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Risk-Adapted Approach to clinical trials and Risk Assessments From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The MHRA have implemented a dual strategy for a risk-adapted approach to clinical trials in the UK. 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 January 28, 2022 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Oversight and monitoring of investigational medical product trials From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 To assist sponsors and those conducting trials on implementing adequate oversight and monitoring processes for trials of investigational medical products. 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, 2022 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Provisional determination eligibility criteria From Therapeutic Goods Administration (TGA) 🇦🇺 Update to currency of data required for criteria assessment 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 26, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Infrared (IR) thermometers: caution in use From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 The MHRA has become increasingly aware of infrared thermometers being sold in the UK that do not comply with the 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 July 27, 2021 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Examples of software and mobile applications illustrating regulatory positioning From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Reference document Examples of software and mobile applications illustrating regulatory positioning 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 May 25, 2021 Other (Non-Commercial) 0 reuses 0 favorites
CPG Sec. 390.400 Examples of Electronic Products Subject to the Reporting Requirements Under 21 CFR 1000.15(a) From Food and Drug Administration (FDA) 🇺🇸 This document is a Compliance Policy Guide (CPG) titled "CPG Sec. 390.400 Examples of Electronic Products Subject to the Reporting Requirements Under 21 CFR 1000.15(a)". It falls under the topic of "Administrative / Procedural". 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 May 5, 2021 Other (Public Domain) 0 reuses 0 favorites