21 CFR Chapter I Subchapter H β Medical Devices β Part 888 Orthopedic 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 888 Orthopedic 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
Electronic Submission Template for Medical Device De Novo Requests: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ Guidance document outlining the electronic submission template for medical device De Novo requests, aimed at industry and FDA staff. Focus on electronic submissions and premarket topics. 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 1 month ago Other (Public Domain) 0 reuses 0 favorites
Medical devices From European Medicines Agency (EMA) πͺπΊ Medical devices are regulated at EU Member State level, but the European Medicines Agency (EMA) is involved in the regulatory process. Metadata quality: Metadata quality: Data description filled 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: 66.66666666666666/100 Updated on May 21, 2024 Other (Public Domain) 0 reuses 0 favorites
Economic operators From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Learn about economic operators and their role in reporting incidents and FSCAs (vigilance). 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 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Slide Template for IMDRF Membership Application Presentations From International Medical Device Regulators Forum (IMDRF) π Slide Template (MS PowerPoint) to assist in the development of presentations by Regulatory Authorities making IMDRF Membership Applications 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 May 20, 2024 Other (Public Domain) 0 reuses 0 favorites
Preliminary re-assessment review (PRAR) form template (MDR) From European Commission πͺπΊ A template for the Preliminary Re-assessment review (PRAR) form under the MDR. 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 May 16, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Preliminary re-assessment review (PRAR) form template (IVDR) From European Commission πͺπΊ A template for the Preliminary Re-assessment Review (PRAR) form under the IVDR. 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 May 16, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Preliminary assessment review (PAR) form template (MDR) From European Commission πͺπΊ A template for Preliminary Assessment Review (PAR) form under the MDR. 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 May 16, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Preliminary assessment review (PAR) form template (IVDR) From European Commission πͺπΊ A template for Preliminary Assessment Review (PAR) form under the IVDR. 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 May 16, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Draft Australian UDI Bulk Upload Template From Therapeutic Goods Administration (TGA) π¦πΊ A Microsoft Excel template for sponsors and manufacturers for uploading bulk UDI records to the Australian UDI Database 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 16, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Summary of safety and performance template From European Commission πͺπΊ A document titled "Summary of safety and performance template" covering topics related to In Vitro Diagnostic medical devices (IVD). 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 15, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Recall action templates From Therapeutic Goods Administration (TGA) π¦πΊ 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
EUDAMED β User guides and templates From European Commission πͺπΊ This document provides user guides and templates for EUDAMED, a system for medical device registration and monitoring in the EU. 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
Clinical Investigation Plan Synopsis Template From European Commission πͺπΊ 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
GN-15-R11 Guidance on Medical Device Product Registration (2024 Mar) PUB From Health Sciences Authority (HSA) πΈπ¬ Provides guidelines on product registration for medical devices. 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
Reformatting Product Information: Frequently asked questions From Therapeutic Goods Administration (TGA) π¦πΊ Update about the transitionary arrangements for reformatting product information, including accessing a fee waiver 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 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Australian declaration of conformity templates (IVDs) From Therapeutic Goods Administration (TGA) π¦πΊ 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
Device Specific Vigilance Guidance (DSVG) Template From European Commission πͺπΊ This document is a template for Device Specific Vigilance Guidance (DSVG) and covers topics related to Post-Market Surveillance and Vigilance (PMSV). 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 30, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Annual reports From Therapeutic Goods Administration (TGA) π¦πΊ Information on annual reporting requirements for sponsors of 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 on January 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Common issues identified during clinical trial applications From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ This guidance identifies common issues with validation and assessment of clinical trial applications and how to avoid them. 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 6, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites