21 CFR Chapter I Subchapter H – Medical Devices – Part 870 Cardiovascular Devices From Food and Drug Administration (FDA) 🇺🇸 A regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – 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 – Medical Devices – Part 888 Orthopedic Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – 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
Direct Final Rule Procedures: Guidance for FDA and Industry From Food and Drug Administration (FDA) 🇺🇸 Guidance document providing procedures for FDA and industry regarding direct final rule implementation. 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Declare the discontinuation of a medical device or in vitro diagnostic medical device From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Procedure Declare a medical device or in vitro diagnostic medical device discontinued or no longer marketed 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 Other (Non-Commercial) 0 reuses 0 favorites
International Recognition Procedure From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How to use the procedure for medicines licensing applications. 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 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Recall coordinators for therapeutic goods From Therapeutic Goods Administration (TGA) 🇦🇺 Recall coordinators play an important part in the uniform recall procedure for therapeutic goods 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
FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on FDA and industry procedures for Section 513(g) requests under the Federal Food, Drug, and Cosmetic Act. 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 month ago Other (Public Domain) 0 reuses 0 favorites
Notification of Post Market clinical investigation with additional invasive or burdensome procedures From Ministry of Health (Italy) (MDS) 🇮🇹 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 August 8, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Requesting a waiver for a medical device without CE marking From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Procedure Requesting a waiver for a medical device without CE marking 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 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical devices - Requesting authorization for a clinical investigation From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Procedure Medical devices - Requesting authorization for a clinical investigation 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 7, 2024 Other (Non-Commercial) 0 reuses 0 favorites
In vitro diagnostic medical devices - Requesting authorization for a performance study From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Procedure In vitro diagnostic medical devices - Requesting authorization for a performance study 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 7, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical devices From European Medicines Agency (EMA) 🇪🇺 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
Manage a recall From Therapeutic Goods Administration (TGA) 🇦🇺 Recall procedures to be followed when there is a potential health risk. 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 10, 2024 Other (Non-Commercial) 0 reuses 0 favorites
IMDRF Standard Operating Procedures From International Medical Device Regulators Forum (IMDRF) 🌍 Procedural document: IMDRF/MC/N2 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 4, 2024 Other (Public Domain) 0 reuses 0 favorites
Medical devices - Clinical investigations vigilance From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Procedure Medical devices - Vigilance of clinical investigations 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
In vitro diagnostic medical devices - Performance studies vigilance From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 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
Conditions governing advertising authorization applications for medical devices (MD/IVDMD) From National Agency for the Safety of Medicines and Health Products (ANSM) 🇫🇷 Procedure Conditions governing requests for advertising authorization for medical devices (MD/IVDMD) 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
System or procedure packs From Therapeutic Goods Administration (TGA) 🇦🇺 Information for manufactures and sponsors of medical device systems or procedure packs. 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Conformity assessment procedures for immunohaematology reagents From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance outlines ARTG and conformity assessment procedures for immunohaematology reagents (IHRs) requirements, that manufacturers and sponsors need to know. 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 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
National register of breast prosthetic implants From Ministry of Health (Italy) (MDS) 🇮🇹 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,… 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