Wholesalers & manufacturers guidance following agreement of the Windsor Framework From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Actions QPs, RPis and RPs need to take following agreement of the Windsor Framework 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 week ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Export certificates (Free Sales Certificates) From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 Learn about export certificates, including free sales certificates, and other related 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 2 weeks ago Other (Non-Commercial) 0 reuses 0 favorites
Overview From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇭 An overview of SwissDamed. 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
Proposal for a COUNCIL DECISION on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning an amendment to Annex II (Technical regulations, standards, testing and certification) and Protocol 37 (containing the list provided for in Article 101) to the EEA Agreement (Reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices) From European Parliament 🇪🇺 A proposal for a decision within the European Union regarding an amendment to technical regulations and protocols in the EEA Agreement for enhanced crisis management in medicinal products and medical devices. 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 11, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
EUDAMED – User guides and templates From European Commission 🇪🇺 This document provides user guides and templates for EUDAMED, a system for medical device registration and monitoring in the EU. 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 April 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
EUDAMED – Technical documentation From European Commission 🇪🇺 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
Agreements between the European Union and non-EU countries From Ministry of Health (Italy) (MDS) 🇮🇹 European Union has concluded trade agreements with non-EU countries. You can consult the list of trade agreements for detailed information on the European Union website on the Non-EU Markets page . This section provides in-depth information on: Agreement between the European Union and the United… 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 25, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
International agreements and arrangements for GMP clearance From Therapeutic Goods Administration (TGA) 🇦🇺 International agreements and arrangements for GMP clearance 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 December 12, 2023 Other (Non-Commercial) 0 reuses 0 favorites
CPG Sec. 100.950 International Partnership Agreements for Compliance Activities From Food and Drug Administration (FDA) 🇺🇸 This document is titled "CPG Sec. 100.950 International Partnership Agreements for Compliance Activities" and 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 September 29, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical devices reforms: Mutual Recognition Agreements (MRA) From Therapeutic Goods Administration (TGA) 🇦🇺 An MRA is in place between Australia and the European Community. This provides for the mutual acceptance of conformity assessment for medical devices. 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 September 21, 2023 Other (Non-Commercial) 0 reuses 0 favorites
International cooperation From Therapeutic Goods Administration (TGA) 🇦🇺 The TGA works closely with overseas regulatory agencies and has a number of agreements with them. 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 21, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Agreement between an organization representing multiple legal manufacturers within a single company and an authorized representative From Saudi Food and Drug Authority (SFDA) 🇸🇦 Agreement between an organization representing multiple legal manufacturers and an authorized representative form. 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 February 16, 2023 Other (Public Domain) 0 reuses 0 favorites
Agreement between a single legal manufacturer and an authorized representative From Saudi Food and Drug Authority (SFDA) 🇸🇦 Agreement between a legal manufacturer and an authorized representative form. 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 February 16, 2023 Other (Public Domain) 0 reuses 0 favorites
Australia-United States Free Trade Agreement From Therapeutic Goods Administration (TGA) 🇦🇺 Find out how the free trade agreement affects your application to include a product on the Australian Register of Therapeutic Goods. 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 11, 2022 Other (Non-Commercial) 0 reuses 0 favorites
The Medical Devices (Northern Ireland Protocol) Regulations 2021 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations make provision for the implementation in respect of Northern Ireland of Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and… 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 27, 2021 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
The Medical Devices (Amendment etc.) (EU Exit) Regulations 2020 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations are made in exercise of the powers in sections 8(1) and 8C of the European Union (Withdrawal) Act 2018 (c. 16) in order to address failures of retained EU law to operate effectively and other deficiencies (in particular under section 8(2)(a)) arising from the withdrawal of the… 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 8, 2020 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
Letter of agreement to extend the comment period for communication G/TBT/N/CHN/729 From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2010-10116 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 9, 2010 Other (Public Domain) 0 reuses 0 favorites
The Medical Devices Regulations 2002 From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 These Regulations contain the legislative measures necessary for the implementation of three European Community Directives: Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, as amended; Council Directive 93/42/EEC… 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 13, 2002 Open Government Licence 3.0 (United Kingdom) 0 reuses 0 favorites
Proposal for a Council Decision determining the Community position for a Decision of the Joint Committee on amending the sectoral annexes on telecommunications terminal equipment, information technology equipment and radio transmitters, on electromagnetic compatibility, on electrical safety, on recreational craft and on medical devices of the Agreement on mutual recognition between the European Community and Canada From European Parliament 🇪🇺 This document is a proposal for a decision on amending sectoral annexes related to telecommunications, IT equipment, radio transmitters, and more. 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 September 22, 2000 Creative Commons Attribution 4.0 0 reuses 0 favorites