MHRA consultation on statutory fees - proposals on ongoing cost recovery From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 Consultation on proposals to update the MHRA's statutory fees to ensure they continue to recover their costs. 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 1 week ago Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Training announcements From Ministry of Food and Drug Safety (MFDS) 🇰🇷 Get the latest updates on MFDS training announcements. 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 month ago Other (Public Domain) 0 reuses 0 favorites
Medical devices From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Last update: August 14, 2024 EC survey active until October 11: The European Commission (EC) is considering extending the use of electronic instructions for all medical devices for professional use (currently, only some medical devices are allowed to be used... 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 August 14, 2024 Other (Public Domain) 0 reuses 0 favorites
In vitro diagnostic medical devices From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Last update: August 14, 2024 EC survey active until October 11: The European Commission (EC) is considering extending the use of electronic instructions for all medical devices for professional use (currently, only some medical devices are allowed to be used... 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 August 14, 2024 Other (Public Domain) 0 reuses 0 favorites
Ways to stay informed about medical devices From Health Canada 🇨🇦 Stay informed about breast implant updates. 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 31, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Updates to the list of recognized standards for medical devices and draft guidance: Notice From Health Canada 🇨🇦 Notice on Health Canada's proposed changes to the guidance on recognized standards 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 July 25, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Share your views: Updates made to list of recognized standards for medical devices and draft guidance From Health Canada 🇨🇦 Health Canada invites you to comment on proposed changes to the guidance on the list of recognized standards 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 July 25, 2024 Open Government License 2.0 (Canada) 0 reuses 0 favorites
SCHEER - UPDATE of the GUIDELINES on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties From European Commission 🇪🇺 SCHEER - UPDATE of the GUIDELINES on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties 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 June 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Information about Poly Implant PIP breast implants From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Last update: January 22, 2021 Briefing Notes Protocol for the explantation, follow-up and replacement of Poly Implant Prothese (P.I.P.) breast prostheses List of Reference Centers/Services Briefing Notes October 30, 2013: Update of information and recommendations on Poly Implant Prothèse (PIP)… 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 June 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Incident reporting by patients From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Last update: November 10, 2020 Medical device incident reporting Medical device vigilance system: incident reporting by patients and users What is a Medical Device? What is the Medical Device Vigilance System? What can I report? Who can report? How can I report? How can I report? 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, 2024 Other (Public Domain) 0 reuses 0 favorites
Incident reporting by companies From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Last update: November 23, 2021 Included are the notification forms for the Guidelines on the Medical Device Vigilance System that can be completed and submitted by email to psvigilancia@aemps.es or by fax to +34918225289 Notification Form. Incident Report 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 June 10, 2024 Other (Public Domain) 0 reuses 0 favorites
ESSURE® device information From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Last update: July 11, 2019 Informative Notes Web Publication Document Title 10/16/18 María Luisa Carcedo presents the Action Guide for patients carrying the Essure® contraceptive Press Release 10/16/18 Publication of the action guide for a patient carrying the Essure® device PS Informative Note,... 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 June 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Clinical investigations with medical devices From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Updated: 30 January 2023 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices (hereinafter "Regulation") sets out the general requirements in relation to clinical investigations involving medical devices in Chapter VI and the... 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 June 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Alerts - Medical Devices From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Last updated: December 20, 2018 The purpose of medical device alerts is to bring to the attention of healthcare professionals and/or users of such devices, the potential risks that may arise from their use and the measures to be taken to minimize or eliminate them.... 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, 2024 Other (Public Domain) 0 reuses 0 favorites
National register of breast prosthetic implants From Ministry of Health (Italy) (MDS) 🇮🇹 Breast implants , commonly implanted for cosmetic or reconstructive reasons, are class III medical devices, the highest risk class, regulated by Legislative Decree No. 137 of August 5, 2022 and EU Regulation 745/2017 . The Ministry of Health, as the Competent Authority on medical devices in Italy,… 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 5, 2024 Creative Commons Attribution 3.0 0 reuses 0 favorites
Information on the medical device vigilance system and on the functions of the person in charge of vigilance at the health care facilities From Spanish Agency for Medicines and Medical Devices (AEMPS) 🇪🇸 Pdf format Date of update: June 29, 2015 Reference: AEMPS/CTI-PS/June 2015 This document is addressed to the Heads of Vigilance of Medical Devices of the Health Centers and has been prepared jointly with the Autonomous Communities within the Technical Committee of Inspection of the AEMPS... 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 5, 2024 Other (Public Domain) 0 reuses 0 favorites
Clinical trial notification (CTN) form - user guide From Therapeutic Goods Administration (TGA) 🇦🇺 The user guide for the Clinical Trial Notification (CTN) form has been updated to reflect the recent updates to the online CTN 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 June 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Update on the guidelines on the benefit-risk assessment of the presence of phthalates in certain medical devices covering phthalates which are carcinogenic, mutagenic, toxic to reproduction (CMR) or have endocrine-disrupting (ED) properties From European Commission 🇪🇺 Document provides an update on guidelines for assessing the presence of harmful phthalates in medical devices, focusing on carcinogenic, mutagenic, reproductive toxic, and endocrine-disrupting properties. Topics include other guidance documents. 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 June 18, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Guidance on Personal Protective Equipment: health professionals From Therapeutic Goods Administration (TGA) 🇦🇺 Information to help healthcare organisations update their operating procedures. 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 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
UDI: News and updates From Therapeutic Goods Administration (TGA) 🇦🇺 Read the latest news and updates. 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 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites