ZL000_00_036e_WL Guidance document GMP compliance by foreign manufacturers From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Guidance document on GMP compliance by foreign manufacturers. 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 April 15, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Normative Instruction - IN no. 290 of 04/04/2024 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Establishes, under the terms of Collegiate Board Resolution - RDC No. 741, of August 10, 2022, an optimized procedure for the analysis and decision of medical device registration petitions, through the use of analyses carried out by an Equivalent Foreign Regulatory Authority (AREE). 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 April 8, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of 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 on March 18, 2024 Other (Public Domain) 0 reuses 0 favorites
Registration of in vitro diagnostic medical devices in the national database From Ministry of Health (Italy) (MDS) 🇮🇹 Waiting for the fully functionality of European Database Eudamed , at the moment in Italy the obligations provided for in Article 10 of Legislative Decree 332/2000 shall continue to apply, untill twenty-four months after the date of the publication of the notice on the functionality of Eudamed. 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 14, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Foreign inspections From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Foreign inspections: Regulation 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 February 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical Device User Fee Small Business Qualification and Certification: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance for small businesses on qualifying and certifying for medical device user fees. 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 January 17, 2024 Other (Public Domain) 0 reuses 0 favorites
CPG Sec. 110.700 Seizures by the U.S. Customs Service of Prohibited Articles of Foreign Origin Not Intended for Entry into the United States From Food and Drug Administration (FDA) 🇺🇸 This document is a Compliance Policy Guide (CPG) titled "Seizures by the U.S. Customs Service of Prohibited Articles of Foreign Origin". 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 September 29, 2023 Other (Public Domain) 0 reuses 0 favorites
CPG Sec. 110.600 FDA Authority Over Products of Foreign Origin Located in Foreign Trade Zones, Bonded Warehouses or on Bonded Carriers From Food and Drug Administration (FDA) 🇺🇸 This document discusses FDA's authority over foreign products in foreign trade zones, bonded warehouses, or on bonded carriers. 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 September 29, 2023 Other (Public Domain) 0 reuses 0 favorites
CPG Sec. 110.200 Export of FDA Regulated Products from U.S. Foreign Trade Zones From Food and Drug Administration (FDA) 🇺🇸 This document is a Compliance Policy Guide (CPG) titled "Export of FDA Regulated Products from U.S. Foreign Trade Zones". 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 September 29, 2023 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 803 Medical Device Reporting From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 803 Medical Device Reporting". 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 March 31, 2023 Other (Public Domain) 0 reuses 0 favorites
Foreign risk notification for medical devices guidance document: Background From Health Canada 🇨🇦 This guidance document is to help manufacturers and importers of medical devices understand and comply with the regulatory requirements on foreign risk notification (FRN). 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 10, 2022 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Implementation of Device Registration and Listing Requirements Enacted in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Medical Device User Fee and Modernization Act of 2002, and Title II of the Food and Drug Administration Amendments Act of 2007 From Food and Drug Administration (FDA) 🇺🇸 Document number 2012-18764. The Food and Drug Administration (FDA) is amending its regulations to reflect recent statutory amendments to the device registration and listing provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Food and Drug Administration Amendments Act of 2007… 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 August 2, 2012 Other (Public Domain) 0 reuses 0 favorites
Q & A for the Handling of Clinical Trial Results on Medical Devices Obtained in Foreign Countries From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵 PFSB/ELD/ OMDE Administrative Notice 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 June 23, 2006 Other (Public Domain) 0 reuses 0 favorites
Handling of clinical study data on medical devices which was carried out in foreign countries From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵 PFSB/MDE Notification No. 0331006 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 31, 2006 Other (Public Domain) 0 reuses 0 favorites
Handling of the data of clinical studies for medical devices conducted in foreign countries From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵 PAB/MHW Notification No. 479 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 31, 1997 Other (Public Domain) 0 reuses 0 favorites
Regulatory Information From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵 A document discussing regulatory information related to reviews and related 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 April 13, 2024 Other (Public Domain) 0 reuses 0 favorites
Registration Application for Foreign Manufacturers of Medical Devices and In Vitro Diagnostic Products From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵 A document outlining the registration process for foreign manufacturers of medical devices and in vitro diagnostic products, focusing on assessment-related operations. 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 days ago Other (Public Domain) 0 reuses 0 favorites
Consultations From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵 PMDA consultations. 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 30, 2024 Other (Public Domain) 0 reuses 0 favorites
Accreditation of Foreign Manufacturers From Pharmaceuticals and Medical Devices Agency (PMDA) 🇯🇵 This document discusses the accreditation process for foreign manufacturers. 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 April 10, 2024 Other (Public Domain) 0 reuses 0 favorites