Medical devices reforms: reclassification of surgical mesh From Therapeutic Goods Administration (TGA) 🇦🇺 Strengthened regulation of surgical mesh protects patient safety. 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 (Non-Commercial) 0 reuses 0 favorites
Submissions received: Proposed reclassification of spinal implantable medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Publication of submissions to the public consultation paper Proposed reclassification of spinal implantable 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Submissions received: Potential reclassification of active medical devices for diagnosis and patient therapy From Therapeutic Goods Administration (TGA) 🇦🇺 Publication of submissions to the public consultation paper Potential reclassification of active medical devices for diagnosis and patient therapy 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
Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device From Food and Drug Administration (FDA) 🇺🇸 Document number 2024-10895. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying the ultrasound cyclodestructive device, a postamendments class III device (product code LZR), into class II (special controls), subject to premarket notification. FDA is… 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 20, 2024 Other (Public Domain) 0 reuses 0 favorites
Reclassification of spinal implantable medical devices 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
Reclassification of medical devices that are substances to be introduced into the body or applied to and absorbed by the skin 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
Reclassification of medical devices that administer medicines or biologicals by inhalation 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
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
Medical devices reforms: Reclassification of certain medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 The reclassification of certain medical devices will take effect from 25 November 2021. 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 9, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Reclassification of active medical devices for therapy with a diagnostic function From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance is to assist sponsors to comply with new 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 9, 2024 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H – Medical Devices – Part 860 Medical Device Classification Procedures From Food and Drug Administration (FDA) 🇺🇸 This document is a regulation titled "Medical Device Classification Procedures" under 21 CFR Chapter I Subchapter H. 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
Reclassification of surgical mesh devices From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance to assist sponsors with the reclassification of surgical mesh devices 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 29, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Reclassification of Active Implantable Medical Devices (AIMD) From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance is to assist sponsors comply with new 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 May 5, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Commission Implementing Regulation (EU) 2022/2347 of 1 December 2022 laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose (Text with EEA relevance) From European Parliament 🇪🇺 Commission Implementing Regulation (EU) 2022/2347 establishes rules for reclassifying certain active products without a medical purpose. 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 1, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
COMMISSION IMPLEMENTING REGULATION (EU) /... laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose From European Parliament 🇪🇺 This document is an implementing regulation that establishes rules for the reclassification of certain active products without a medical purpose. 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 1, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
Microbiology Devices; Reclassification of Human Immunodeficiency Virus Viral Load Monitoring Tests From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-23868. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order to reclassify human immunodeficiency virus (HIV) viral load monitoring tests, postamendments class III devices with the product code MZF, into class II (special controls), subject to… 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 4, 2022 Other (Public Domain) 0 reuses 0 favorites
Frequently asked questions (FAQs) on reclassification of medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Reclassification of medical devices frequently asked questions. 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 October 26, 2022 Other (Non-Commercial) 0 reuses 0 favorites
COMMISSION IMPLEMENTING REGULATION (EU) …/... laying down rules for the application of Regulation (EU) 2017/745 of the European Parliament and of the Council as regards reclassification of groups of certain active products without an intended medical purpose From European Parliament 🇪🇺 Draft implementing regulation on reclassification of certain active products without medical purpose under Regulation (EU) 2017/745. 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 August 11, 2022 Creative Commons Attribution 4.0 0 reuses 0 favorites
General and Plastic Surgery Devices; Reclassification of Optical Diagnostic Devices for Melanoma Detection and Electrical Impedance Spectrometers, To Be Renamed Computer-Aided Devices Which Provide Adjunctive Diagnostic Information About Lesions Suspicious for Melanoma From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-13954. The Food and Drug Administration (FDA, Agency, or we) is proposing on its own initiative to reclassify optical diagnostic devices for melanoma detection and electrical impedance spectrometers, both of which are postamendments class III devices (product codes OYD 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 June 30, 2022 Other (Public Domain) 0 reuses 0 favorites
Microbiology Devices; Reclassification of Human Immunodeficiency Virus Serological Diagnostic and Supplemental Tests and Human Immunodeficiency Virus Nucleic Acid Diagnostic and Supplemental Tests From Food and Drug Administration (FDA) 🇺🇸 Document number 2022-10461. The Food and Drug Administration (FDA, we, or the Agency) is issuing a final order to reclassify certain human immunodeficiency virus (HIV) serological diagnostic and supplemental tests and HIV nucleic acid (NAT) diagnostic and supplemental tests, postamendments class… 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 16, 2022 Other (Public Domain) 0 reuses 0 favorites