Chapter 3 - emissions guidance Northern Ireland From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง The types of emissions a manufacturer or importer of e-cigarettes should notify us about. 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 16, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Chapter 3 - emissions guidance - Great Britain From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง The types of emissions a manufacturer or importer of e-cigarettes should notify us about. 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 16, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Vapes: information for sponsors, importers and manufacturers From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Learn what the regulatory changes mean for the importation and manufacture of therapeutic vapes. 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
EUDAMED โ Topics per Actor From European Commission ๐ช๐บ This document provides an overview of topics related to EUDAMED system categorized by different actors involved in the process. 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
EUDAMED โ Manage From European Commission ๐ช๐บ This document provides guidance on managing the European Database on Medical Devices (EUDAMED), covering key aspects and procedures for effective utilization. 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
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 807 Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ 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
Questions and Answers on Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 From European Commission ๐ช๐บ Get answers to questions about Articles 13 & 14 of Regulation (EU) 2017/745 and Regulation (EU) 2017/746 regarding authorised representatives, importers, and distributors. 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 December 20, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Withdraw your ARTG application From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Guidance for medical device sponsors (includes importers and exporters) about how to withdraw your ARTG application. 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 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Obligations for authorised representatives, importers and distributors From Swiss Agency for Therapeutic Products (Swissmedic) ๐จ๐ญ Learn about the obligations for authorised representatives, importers, and distributors in relation to market access. 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 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 895 Banned Devices From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 895 Banned 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 July 17, 2023 Other (Public Domain) 0 reuses 0 favorites
Reporting system for in vitro diagnostic medical devices From Ministry of Health (Italy) (MDS) ๐ฎ๐น The Ministry of Health carries out the activities of monitoring and investigating reports from healthcare professionals and manufacturers. On Sept. 28, 2022, Legislative Decree No. 138 of Aug. 5, 2022 , came into force, which in Article 13 provides fulfillments for manufacturers of in vitroโฆ 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 3, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
GN-02-R5 Guidance on Licensing of Manufacturers Importers and Wholesalers of MD (2023 Jul) PUB From Health Sciences Authority (HSA) ๐ธ๐ฌ Covers licensing requirements for manufacturers, importers and wholesalers of medical devices. 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 July 1, 2023 Other (Public Domain) 0 reuses 0 favorites
Executive order on fees for importers and distributors of medical devices etc. From Danish Medicines Agency (DKMA) ๐ฉ๐ฐ An executive order outlining new fee regulations for importers and distributors of medical devices and related products. 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 20, 2023 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 803 Medical Device Reporting From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ 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
MDR Circular 5/2022: On certain aspects of the labelling and instruction handbook insurance activities of importers, distributors (and other economic operators), i.e. Article 16 of the MDR From National Institute of Pharmacy and Nutrition (OGYรI) ๐ญ๐บ A newsletter discussing MDR Circular 5/2022 focusing on labelling, instruction handbook insurance activities for importers, distributors, and other economic operators under Article 16 of the MDR. 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 29, 2023 Other (Public Domain) 0 reuses 0 favorites
Guidance on Authorised Representatives Regulation (EU) 2017/745 and Regulation (EU) 2017/746 From European Commission ๐ช๐บ Get guidance on the regulations for Authorised Representatives, Importers, and Distributors in the EU (Regulation (EU) 2017/745 and Regulation (EU) 2017/746). 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 September 6, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Foreign risk notification for medical devices guidance document: Background From Health Canada ๐จ๐ฆ 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
Attestation for Importers of Minimally Manipulated Biological Products Intended for Human Application Form From Saudi Food and Drug Authority (SFDA) ๐ธ๐ฆ A form for importers of minimally manipulated biological products intended for human application, requiring attestation. 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 9, 2022 Other (Public Domain) 0 reuses 0 favorites
Provision No. 2580/2022 From National Administration of Drugs, Food and Medical Devices (ANMAT) ๐ฆ๐ท The application for Renewal of the Good Manufacturing Practices Certificate for manufacturers and/or importers of medical products and/or diagnostic products for in vitro use governed by ANMAT Provision No. 7425/13 and its amendments shall be processed in accordance with the provisions of thisโฆ 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, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
Provision No. 2096/2022 From National Administration of Drugs, Food and Medical Devices (ANMAT) ๐ฆ๐ท The application for Renewal of the Good Manufacturing Practices Certificate for manufacturers and/or importers of medical products and/or diagnostic products for in vitro use governed by ANMAT Provision No. 7425/13, as amended, shall be processed in accordance with the provisions of thisโฆ 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, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites