Guidance for Industry: Preparing a Color Additive Petition for Submission to the Center for Food Safety and Applied Nutrition for Color Additives Used in or on Contact Lenses From Food and Drug Administration (FDA) 🇺🇸 A guidance document providing instructions for submitting a color additive petition for contact lenses to the Center for Food Safety and Applied Nutrition. 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 1 week ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 886 Ophthalmic Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 886 Ophthalmic 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
Contact details for Guideline SAHPGL-MD-03 Medical Device Vigilance: Adverse Events Reporting for License Holders From South African Health Products Regulatory Authority (SAHPRA) 🇿🇦 Document Number MD01-2024/2025 - Version 1 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 9, 2024 Other (Public Domain) 0 reuses 0 favorites
Users From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇠This document is about users and focuses on reporting incidents and FSCAs (vigilance). 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 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Submissions received: Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems From Therapeutic Goods Administration (TGA) 🇦🇺 Publication of submissions to the public consultation paper Proposed changes to the classification of medical devices used in direct contact with the heart, central circulatory or central nervous systems 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Devices reforms contact box From Therapeutic Goods Administration (TGA) 🇦🇺 Contact details for the Medical Devices team at the Therapeutic Goods Administration. 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 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 878 General and Plastic Surgery Devices From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "21 CFR Chapter I Subchapter H – Medical Devices – Part 878 General and Plastic Surgery 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 June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 800 General From Food and Drug Administration (FDA) 🇺🇸 21 CFR Chapter I Subchapter H - Medical Devices - Part 800 General: A regulation governing medical 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 June 4, 2024 Other (Public Domain) 0 reuses 0 favorites
Vigilance From Swiss Agency for Therapeutic Products (Swissmedic) 🇨🇠This docuemnt discusses vigilance of healthcare institutions. 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 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Contact us From Therapeutic Goods Administration (TGA) 🇦🇺 How to contact us by phone, email or post. 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 15, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Contact MHRA From Medicines and Healthcare products Regulatory Agency (MHRA) 🇬🇧 How to contact MHRA for specific services or enquiries. 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 26, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Reclassification of medical devices in direct contact with the heart, central circulatory and central nervous systems From Therapeutic Goods Administration (TGA) 🇦🇺 Updated guidance to reflect new amendments made to the regulations. 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 10, 2024 Other (Non-Commercial) 0 reuses 0 favorites
TGA operations over the holiday period 2023-24 From Therapeutic Goods Administration (TGA) 🇦🇺 Find out how to best contact us over the holiday period for 2023-24 and see our urgent contact information. 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 18, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Digital nursing applications (DiPA) From Federal Institute for Drugs and Medical Devices (BfArM) 🇩🇪 Current status DiPA Guide Handout of data processing outside Germany DiPAV Kick-off meeting through the innovation officeInnovation office Interesting facts Contact Further information 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 November 26, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Device Shortages Single Point of Contact (SPOC) Working Party From European Medicines Agency (EMA) 🇪🇺 Information on medical device shortages and Single Point of Contact (SPOC) Working Party. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated on August 17, 2023 Other (Public Domain) 0 reuses 0 favorites
Contact information From National Institute of Pharmacy and Nutrition (OGYÉI) ðŸ‡ðŸ‡º A document containing OGYÉI contact information details. 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 21, 2023 Other (Public Domain) 0 reuses 0 favorites
Guidance for Premarket Submissions of Orthokeratology Rigid Gas Permeable Contact Lenses - Guidance for Industry From Food and Drug Administration (FDA) 🇺🇸 Guidance document providing instructions for premarket submissions of orthokeratology rigid gas permeable contact lenses. 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 August 17, 2023 Other (Public Domain) 0 reuses 0 favorites
Hydrogen Peroxide-Based Contact Lens Care Products: Consumer Labeling Recommendations - Premarket Notification (510(k)) Submissions: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) 🇺🇸 This document provides guidance on labeling recommendations for hydrogen peroxide-based contact lens care products. 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 July 26, 2023 Other (Public Domain) 0 reuses 0 favorites
Commission Delegated Regulation (EU) 2023/2197 of 10 July 2023 amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses From European Parliament 🇪🇺 Commission Delegated Regulation (EU) 2023/2197 amends EU Regulation 2017/745 on Unique Device Identifiers for contact lenses. 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 10, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
COMMISSION DELEGATED REGULATION (EU) /... amending Regulation (EU) 2017/745 of the European Parliament and of the Council, as regards the assignment of Unique Device Identifiers for contact lenses From European Parliament 🇪🇺 This document is a delegated regulation that amends the EU regulation on Unique Device Identifiers for contact lenses. 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 10, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites