21 CFR Chapter I Subchapter H โ Medical Devices โ Part 801 Labeling From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 801 Labeling". 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
Principles of Labelling for Medical Devices and IVD Medical Devices From International Medical Device Regulators Forum (IMDRF) ๐ Technical document: IMDRF/GRRP WG/N52 FINAL:2024 (Edition 2) 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 April 26, 2024 Other (Public Domain) 0 reuses 0 favorites
Guidance Document: Recognition and Use of Standards under the Medical Devices Regulations From Health Canada ๐จ๐ฆ 2006 Health Canada guidance document providing guidance for medical devices manufacturers on the use of standards in demonstrating compliance with the Safety and Effectiveness Requirements and Labelling Requirements of the Canadian Medical Devices Regulations 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 15, 2024 Open Government License 2.0 (Canada) 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
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 862 Clinical Chemistry and Clinical Toxicology Devices From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H - Medical Devices - Part 862 Clinical Chemistry and Clinical Toxicology 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 February 5, 2024 Other (Public Domain) 0 reuses 0 favorites
Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This is a guidance document titled "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile." It focuses on premarket topics. 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 January 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Medical devices labelling and information From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Labelling and other information provided with medical 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 January 2, 2024 Other (Non-Commercial) 0 reuses 0 favorites
CPG Sec.140.500 Metric Declarations of Quantity of Contents on Product Labels From Food and Drug Administration (FDA) ๐บ๐ธ This document is a Compliance Policy Guide (CPG) titled "CPG Sec.140.500 Metric Declarations of Quantity of Contents on Product Labels". It covers labeling regulations. 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 September 29, 2023 Other (Public Domain) 0 reuses 0 favorites
Manufacture of sterile radiopharmaceuticals labelled with fluorine-18 From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Guidance updated to reflect expectations of the new PIC/S guide to GMP PE009-13 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 30, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Disinfectant Claim Guide: specific claims and non-specific claims From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Information on the different ways the Therapeutic Goods Administration (TGA) regulates disinfectants depending on the intended use and label claims. 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 October 19, 2022 Other (Non-Commercial) 0 reuses 0 favorites
GN-23-R2 Guidance on Labelling for Medical Devices(2022 Sep) PUB From Health Sciences Authority (HSA) ๐ธ๐ฌ Provides information on labelling requirements for 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 September 1, 2022 Other (Public Domain) 0 reuses 0 favorites
Labels for COVID-19 treatments From Therapeutic Goods Administration (TGA) ๐ฆ๐บ To enable timely distribution of COVID-19 treatments, international labels may be used during initial supply in Australia. 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 17, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Contact Lens Care Products Labeling: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ This document is a guidance for industry and FDA staff on labeling contact lens care products. It falls under the premarket topic. 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 1, 2022 Other (Public Domain) 0 reuses 0 favorites
Therapeutic goods orders From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Therapeutic goods must comply with various standards, which determine the consistency of product quality, including label quality. Many of these standards are international standards. However, sometimes it is necessary to specify an Australian standard, either for a particular type of therapeuticโฆ 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 30, 2022 Other (Non-Commercial) 0 reuses 0 favorites
CPG Sec. 300.400 Contamination of Devices Labeled as Sterile From Food and Drug Administration (FDA) ๐บ๐ธ This document is a Compliance Policy Guide (CPG) titled "CPG Sec. 300.400 Contamination of Devices Labeled as Sterile" and focuses on labeling and contamination of sterile 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 May 3, 2021 Other (Public Domain) 0 reuses 0 favorites
Identification Labels for Certain Class I Laser Products (Laser Notice 48) From Food and Drug Administration (FDA) ๐บ๐ธ This document provides guidance on identification labels for certain Class I laser products, as outlined in Laser Notice 48. 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 April 27, 2021 Other (Public Domain) 0 reuses 0 favorites
Guidance Document: How to Complete the Application for a New Medical Device Licence/Medical Device Licence Amendment for a Private Label Medical Device From Health Canada ๐จ๐ฆ 2005 (revised 2011) Health Canada guide 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 9, 2020 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Application for a Medical Device Licence Amendment for a Private Label Medical Device From Health Canada ๐จ๐ฆ 2005 Health Canada form 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 7, 2020 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Labeling - Regulatory Requirements for Medical Devices (FDA 89-4203) From Food and Drug Administration (FDA) ๐บ๐ธ This document provides guidance on the regulatory requirements for labeling medical devices, as outlined by the FDA. 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 March 17, 2020 Other (Public Domain) 0 reuses 0 favorites
Warning Labels For Dye And Multiple Wavelength Lasers (Laser Notice 16) From Food and Drug Administration (FDA) ๐บ๐ธ A guidance document titled "Warning Labels For Dye And Multiple Wavelength Lasers (Laser Notice 16)". 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 March 16, 2020 Other (Public Domain) 0 reuses 0 favorites