Medical devices reforms: IVD companion diagnostics From Therapeutic Goods Administration (TGA) 🇦🇺 Our goal is to harmonise with other jurisdictions (and international standards where necessary). 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
Medical Devices; Quality System Regulation Amendments From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-01709. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final rule to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) regulation to harmonize and modernize the regulation. We are harmonizing to align… 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 2, 2024 Other (Public Domain) 0 reuses 0 favorites
CPG Sec 100.200 FDA Jurisdiction Over Products Composed of Interstate Ingredients From Food and Drug Administration (FDA) 🇺🇸 This document is a Compliance Policy Guide (CPG) titled "CPG Sec 100.200 FDA Jurisdiction Over Products Composed of Interstate Ingredients". 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 October 3, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Devices; Quality System Regulation Amendments From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-03227. The Food and Drug Administration (FDA, the Agency, or we) is proposing to amend the device current good manufacturing practice (CGMP) requirements of the Quality System (QS) Regulation to align more closely with the international consensus standard for devices by… 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 23, 2022 Other (Public Domain) 0 reuses 0 favorites
List of countries and jurisdictions determined to be comparable overseas regulators (CORs) From Therapeutic Goods Administration (TGA) 🇦🇺 List of countries and jurisdictions determined to be comparable overseas regulators (CORs) 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 October 24, 2019 Other (Non-Commercial) 0 reuses 0 favorites
Use of UDI Data Elements across different IMDRF Jurisdictions From International Medical Device Regulators Forum (IMDRF) 🌍 Information document IMDRF/UDI WG/N53FINAL:2019. 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 March 21, 2019 Other (Public Domain) 0 reuses 0 favorites
CPG Sec. 100.350 FDA Jurisdiction on Indian Reservations From Food and Drug Administration (FDA) 🇺🇸 This document is titled "CPG Sec. 100.350 FDA Jurisdiction on Indian Reservations" and it is a Compliance Policy Guide. 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 December 1, 2018 Other (Public Domain) 0 reuses 0 favorites
Provision No. 6052/2013 From National Administration of Drugs, Food and Medical Devices (ANMAT) 🇦🇷 It is hereby established that this provision shall apply to individuals or legal entities that carry out distribution and/or commercialization activities of medical products and/or products for in vitro diagnostic use of third parties outside the jurisdiction where they are authorized… 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 1, 2013 Creative Commons Attribution 4.0 0 reuses 0 favorites
On the issuance of medical equipment business enterprises across provincial jurisdictions to set up additional warehouses regulatory provisions of the notice From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2006-10020 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 May 29, 2006 Other (Public Domain) 0 reuses 0 favorites