Guidance for Industry: Color Additive Petitions - FDA Recommendations for Submission of Chemical and Technological Data on Color Additives for Food, Drugs, Cosmetics, or Medical Devices From Food and Drug Administration (FDA) ๐บ๐ธ This document provides FDA recommendations for submitting chemical and technological data on color additives for food, drugs, cosmetics, or medical devices. 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 1 week ago Other (Public Domain) 0 reuses 0 favorites
Consultation on the International Council for Harmonisation (ICH) M14 From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง Consultation on the ICH E2D(R1) guidelines on General principles on plan, design, and analysis of pharmacoepidemiological studies that utilise real-world data for safety assessment of medicines. 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 3 weeks ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Medical device conformity assessment application From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Information and forms about applications for TGA conformity assessment certificates. 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 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
National Register of Breast Prosthetic Implants - Appointment of data submission manager for distributors From Ministry of Health (Italy) (MDS) ๐ฎ๐น 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 July 25, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission From Therapeutic Goods Administration (TGA) ๐ฆ๐บ We have adopted this International Scientific Guideline - EMA/CHMP/BWP/187338/2014 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on process validation for finished products - information and data to be provided in regulatory submissions From Therapeutic Goods Administration (TGA) ๐ฆ๐บ We have adopted this International Scientific Guideline - EMA/CHMP/CVMP/QWP/BWP/70278/2012-Rev1 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
GHTF Study Group 2 - Post-market Surveillance/Vigilance From International Medical Device Regulators Forum (IMDRF) ๐ GHTF Study Group 2 - Post-market Surveillance/Vigilance documents 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 July 27, 2012 Other (Public Domain) 0 reuses 0 favorites
In vitro diagnostic medical devices - Performance studies vigilance From National Agency for the Safety of Medicines and Health Products (ANSM) ๐ซ๐ท Procedure In vitro diagnostic medical devices - Vigilance of performance studies 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 24, 2024 Other (Non-Commercial) 0 reuses 0 favorites
National register of breast prosthetic implants From Ministry of Health (Italy) (MDS) ๐ฎ๐น Breast implants , commonly implanted for cosmetic or reconstructive reasons, are class III medical devices, the highest risk class, regulated by Legislative Decree No. 137 of August 5, 2022 and EU Regulation 745/2017 . The Ministry of Health, as the Competent Authority on medical devices in Italy,โฆ 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 5, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Guideline on missing data in confirmatory clinical trials From Therapeutic Goods Administration (TGA) ๐ฆ๐บ We have adopted this International Scientific Guideline - EMA/CPMP/EWP/1776/99 Rev. 1. 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 4, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on data monitoring committees From Therapeutic Goods Administration (TGA) ๐ฆ๐บ We have adopted this International Scientific Guideline - EMEA/CHMP/EWP/5872/03 Corr. 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 4, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Use of electronic health record data in clinical investigations - guidance for industry From Therapeutic Goods Administration (TGA) ๐ฆ๐บ We have adopted this International Scientific Guideline - Use of electronic health record data in clinical investigations โ Guidance for industry. 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 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Registration on the list of custom-made medical device manufacturers From Ministry of Health (Italy) (MDS) ๐ฎ๐น Manufacturers who make bespoke medical devices available on the national territory notify the Ministry of Health of their identification data and the list of bespoke medical devices (Article 7, paragraph 1 of Legislative Decree 137/2022), through the online service accessible from the portalโฆ 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 18, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Draft Australian UDI Data Dictionary From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The Australian UDI Data Dictionary includes a list of the fields in the database, including element names, descriptions, permitted values and other metadata. 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 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document provides guidance for leveraging clinical data to support the use of medical devices in pediatric populations. 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 April 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document is a guidance document titled "Evaluation and Reporting of Age-, Race-, and Ethnicity-Specific Data in Medical Device Clinical Studies" for the industry and FDA staff. It covers topics such as clinical studies, good clinical practice, labeling, and premarket evaluation. 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 April 8, 2024 Other (Public Domain) 0 reuses 0 favorites
EUDAMED โ User profiles From European Commission ๐ช๐บ This document provides detailed information on creating and managing user profiles within the EUDAMED system, ensuring efficient access and data management. 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 20, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
EUDAMED โ Technical documentation From European Commission ๐ช๐บ This document provides technical documentation related to EUDAMED, a system for the exchange of information on medical devices within the EU. 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 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
EUDAMED โ Search & view From European Commission ๐ช๐บ This document provides guidance on how to search and view information within the EUDAMED database, facilitating access to relevant data efficiently. 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 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
EUDAMED โ Medical devices From European Commission ๐ช๐บ This document provides detailed information about EUDAMED, a system for managing and exchanging data related to medical devices in the European Union. 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 20, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites