Appeal Options Available to Mammography Facilities Concerning Adverse Accreditation Decisions, Suspension/Revocation of Certificates, or Patient and Referring Provider Notification Orders: Guidance for Mammography Facilities and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ Guidance document outlining appeal options for mammography facilities regarding adverse accreditation decisions, certificate suspension/revocation, and notification orders. Administrative/procedural focus. 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 1 week ago Other (Public Domain) 0 reuses 0 favorites
Export certificates (Free Sales Certificates) From Swiss Agency for Therapeutic Products (Swissmedic) ๐จ๐ญ 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
Medical device conformity assessment application From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Information and forms about applications for TGA conformity assessment 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 on August 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Application instructions: Conformity assessment certification From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Updated guidance on how to apply for a conformity assessment certificate. 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 5, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Export medical devices From Medicines and Healthcare products Regulatory Agency (MHRA) ๐ฌ๐ง Order a certificate of free sale to export medical devices outside the UK. 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 2, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
IVD - Issuance of Certificate of Free Sale (CLV) for the export of in vitro diagnostic medical devices to countries outside the European Union From Ministry of Health (Italy) (MDS) ๐ฎ๐น 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 July 24, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Notified Bodies in Italy for conformity assessment From Ministry of Health (Italy) (MDS) ๐ฎ๐น As of November 26, 2017, provisions are applicable regarding Bodies wishing to operate under Regulation (EU) 2017/745, in the medical device sector, and under Regulation (EU) 2017/746, in the in vitro diagnostic medical device sector. Notified Bodies designated under the previous Directives are noโฆ 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 18, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Request for certificates or certified copies of TGA licences and certificates From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Use this form to request for certificates or certified copies of TGA licences and 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 on July 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Conformity assessment certificate process and timeframes From Therapeutic Goods Administration (TGA) ๐ฆ๐บ An overview for manufacturers applying for a conformity assessment certificate 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 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
DM - Issuance of Certificate of Free Sale for the export of medical devices to countries outside the European Union From Ministry of Health (Italy) (MDS) ๐ฎ๐น 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 7, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
BW302_00_001e_WL Guidance document for requesting product certificates (CPP) From Swiss Agency for Therapeutic Products (Swissmedic) ๐จ๐ญ Guidance document for requesting product certificates. 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 May 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guidance on appropriate surveillance regarding the transitional provisions under Article 120 of the MDR with regard to devices covered by certificates according to the MDD or the AIMDD From European Commission ๐ช๐บ Guidance on surveillance for devices covered by MDD or AIMDD certificates under Article 120 of the MDR. 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 May 27, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Print the ARTG certificate of inclusion for your medical device From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The Australian Register of Therapeutic Goods (ARTG) certificate printing instructions. 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 23, 2024 Other (Non-Commercial) 0 reuses 0 favorites
EUDAMED โ User guides and templates From European Commission ๐ช๐บ 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 โ Technical documentation From European Commission ๐ช๐บ 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
EUDAMED โ Bulk uploading-downloading From European Commission ๐ช๐บ This document provides guidance on bulk uploading and downloading data in EUDAMED, a system for medical device information exchange in 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
Unique device identification system From Ministry of Health (Italy) (MDS) ๐ฎ๐น The unique device identification system ("UDI system") provided for in the Medical Devices Regulation (EU) 2017/745 and the In Vitro Diagnostic Devices (IVD) Regulation (EU) 2017/746 allows for the identification and facilitates the traceability of devices. The system involves: assigning a basicโฆ 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 12, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Process to Request a Review of FDA's Decision Not to Issue Certain Export Certificates for Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document provides guidance on the process to request a review of FDA's decision not to issue certain export certificates for devices. 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 November 3, 2023 Other (Public Domain) 0 reuses 0 favorites
Guidance on significant changes regarding the transitional provision under Article 120 of the MDR with regard to devices covered by certificates according to MDD or AIMDD From European Commission ๐ช๐บ Document provides guidance on significant changes related to transitional provision under Article 120 of the MDR for devices covered by MDD or AIMDD certificates, focusing on Notified Bodies. 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
Application for Certificates for free sale for devices qualifying under Regulation 2023-607 From Health Products Regulatory Authority (HPRA) ๐ฎ๐ช A form for applying for Certificates for free sale for devices meeting Regulation 2023-607 qualifications. 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 August 9, 2023 Other (Public Domain) 0 reuses 0 favorites