Licence Application to Import Distribute or Export Medical Devices From South African Health Products Regulatory Authority (SAHPRA) 🇿🇦 Document Number GLF-MD-06C - Version 4 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Authorization for the import and export of human blood and its products for the manufacture of in vitro diagnostic medical devices 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 June 21, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 879 of 28/05/2024 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Prohibits the manufacture, import and marketing, as well as the use in health services, of mercury and powder for non-encapsulated amalgam alloys indicated for use in dentistry. 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 June 3, 2024 Other (Public Domain) 0 reuses 0 favorites
Importing a medicine or medical device From Therapeutic Goods Administration (TGA) 🇦🇺 Australia has rules on importing medicines and 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 May 24, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Cosmetic injectables: import and supply in Australia From Therapeutic Goods Administration (TGA) 🇦🇺 This fact sheet is for healthcare practitioners to help understand the rules surrounding importation of cosmetic injectables. 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 May 24, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Instructions for sponsors who have interest in supplying a COVID-19 self-test From Therapeutic Goods Administration (TGA) 🇦🇺 New information about importing self-tests. 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 20, 2024 Other (Non-Commercial) 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
21 CFR Chapter I Subchapter H – Medical Devices – Part 812 Investigational Device Exemptions From Food and Drug Administration (FDA) 🇺🇸 Regulation on Investigational Device Exemptions under 21 CFR Chapter I Subchapter H - Medical Devices - Part 812. 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 January 23, 2024 Other (Public Domain) 0 reuses 0 favorites
Notice to import cannabis vaping devices From Therapeutic Goods Administration (TGA) 🇦🇺 You must submit this notice before you import a cannabis vaping device or accessory. 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 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guidance for Sponsor notice – Vaping goods (Notice to import or supply in Australia therapeutic vaping goods) form From Therapeutic Goods Administration (TGA) 🇦🇺 From 1 March 2024, a sponsor notice is a notice that must be given by a sponsor of a vaping good to the TGA before the good is imported into, or supplied in, Australia following domestic manufacture. 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 January 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Import From Therapeutic Goods Administration (TGA) 🇦🇺 Information on the legal requirements for importing therapeutic goods into Australia, including 'unapproved' therapeutic goods and controlled substances. 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 December 25, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Australian Regulatory Guidelines for Medical Devices (ARGMD) From Therapeutic Goods Administration (TGA) 🇦🇺 The guidelines provide information on the import, export and supply of medical devices within Australia. 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 2, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Therapeutic goods import, advertising and supply compliance education strategy From Therapeutic Goods Administration (TGA) 🇦🇺 The strategy outlines the approach we will use to identify, engage with, and educate stakeholders about regulatory requirements and our compliance outcomes. 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 October 26, 2023 Other (Non-Commercial) 0 reuses 0 favorites
About the Australian therapeutic goods legislation From Therapeutic Goods Administration (TGA) 🇦🇺 Legal requirements for the import, export, manufacture and supply of therapeutic goods in Australia. 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 23, 2023 Other (Non-Commercial) 0 reuses 0 favorites
CPG Sec. 110.500 Food and Drug Guaranty - Imports From Food and Drug Administration (FDA) 🇺🇸 This document is a Compliance Policy Guide (CPG) titled "CPG Sec. 110.500 Food and Drug Guaranty - Imports". 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 110.900 Imported Products - Lack of English Labeling From Food and Drug Administration (FDA) 🇺🇸 This document is a Compliance Policy Guide (CPG) titled "CPG Sec 110.900 Imported Products - Lack of English Labeling" and it focuses on labeling requirements. 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
Supply, manufacture or import MDMA or psilocybin (sponsors and manufacturers) From Therapeutic Goods Administration (TGA) 🇦🇺 Information for Australian sponsors on manufacturing, supplying and importing MDMA and psilocybin. 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 September 6, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Application to import or export a therapeutic good that is mercury From Therapeutic Goods Administration (TGA) 🇦🇺 Information and links to the application to import or export a therapeutic good that is mercury form. 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 29, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Import, Advertising and Supply Compliance Priorities 2023-24 From Therapeutic Goods Administration (TGA) 🇦🇺 Read about our new priority areas for compliance activities relating to the import, advertising and supply requirements of the Therapeutic Goods Act 1989 from 2023 to 2024. 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 July 25, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Guidance on Clinical Trials Design of Artificial Intelligence(AI)-based Medical Devices From Ministry of Food and Drug Safety (MFDS) 🇰🇷 This guidance applies to the regulatory pathways of clinical trial approval, manufacturing, and import licensing (subject to clinical trial data submission) or technical documentation review (subject to clinical trial data submission) for machine learning-enabled medical devices that analyze… 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 July 20, 2023 Other (Public Domain) 0 reuses 0 favorites