21 CFR Chapter I Subchapter H โ Medical Devices โ Part 866 Immunology and Microbiology Devices From Food and Drug Administration (FDA) ๐บ๐ธ Regulation on Immunology and Microbiology Devices under 21 CFR Chapter I Subchapter H - Medical Devices, Part 866. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 88.88888888888889/100 Updated 1 day ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 872 Dental Devices From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 872 Dental 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
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 870 Cardiovascular Devices From Food and Drug Administration (FDA) ๐บ๐ธ A regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 870 Cardiovascular 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
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 882 Neurological Devices From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ Part 882 Neurological 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
Guideline on plastic immediate packaging materials From Therapeutic Goods Administration (TGA) ๐ฆ๐บ We have adopted this International Scientific Guideline - CPMP/QWP/4359/03, EMEA/CVMP/205/04 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
List of Ventilators, CPAP, and BiPAP devices containing PE-PUR foam material in the breathing gas pathway From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The TGA has identified additional devices (other than those supplied by Philips Electronics Australia Ltd) that contain PE-PUR foam material for sound abatement purpose in the breathing gas pathway. 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 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Transmissible Spongiform Encephalopathies (TSE): TGA approach to minimising the risk of exposure From Therapeutic Goods Administration (TGA) ๐ฆ๐บ How the TGA assesses the safety of materials derived from human and other animal species, naturally susceptible to TSE, that are used in the manufacture of therapeutic goods. 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 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Learn about in vitro diagnostic (IVD) medical devices From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Introductory material on in vitro diagnostic (IVD) 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 June 13, 2024 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H โ Medical Devices โ Part 878 General and Plastic Surgery Devices From Food and Drug Administration (FDA) ๐บ๐ธ This document is a regulation titled "21 CFR Chapter I Subchapter H โ Medical Devices โ 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
Active implantable medical devices From Spanish Agency for Medicines and Medical Devices (AEMPS) ๐ช๐ธ Last update: July 28, 2022 Contents Legislation Circulars Leaflets, instructions, forms Informative notes Documents of interest Fees Informative material 1. Legislation Spain Europe 2. Circulars Circular 7/04, regulation of clinical research with medical devices Circular 3/01, on clinical researchโฆ 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 May 27, 2024 Other (Public Domain) 0 reuses 0 favorites
Guide no. 63 version 2 of 16/05/2024 From Brazilian Health Regulatory Agency (Anvisa) ๐ง๐ท Guide for the Biological Safety Assessment of Nanotechnology-based Materials for Use in Health. 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 May 20, 2024 Other (Public Domain) 0 reuses 0 favorites
Animal Studies for Dental Bone Grafting Material Devices - Premarket Notification (510(k)) Submissions: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) ๐บ๐ธ Draft guidance document for industry and FDA staff on premarket notification submissions for dental bone grafting material devices in animal studies. 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 March 28, 2024 Other (Public Domain) 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
Therapeutic goods and use of human embryos or human embryonic stem cells or material derived therefrom From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Find out what process to follow if a product is manufactured using a human embryo or a human embryonic stem cell, or any material sourced from such an embryo or stem cell. 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 19, 2023 Other (Non-Commercial) 0 reuses 0 favorites
CPG Sec. 120.100 Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities From Food and Drug Administration (FDA) ๐บ๐ธ A document titled "CPG Sec. 120.100 Fraud, Untrue Statements of Material Facts, Bribery, and Illegal Gratuities" is a Compliance Policy Guide. 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
Patient implant cards and information leaflets From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Patient information leaflets (PILs) and Patient Implant Cards (PICs) are required for all breast implants. 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 September 18, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Guide No. 63 version 1 of 25/07/2023 From Brazilian Health Regulatory Agency (Anvisa) ๐ง๐ท Guide to Biological Safety Assessment of Nanotechnology-based Materials for Health Use Metadata quality: Metadata quality: Data description empty 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: 66.66666666666666/100 Updated on August 4, 2023 Other (Public Domain) 0 reuses 0 favorites
Corrigendum to Commission Delegated Directive (EU)ย 2023/1526 of 16ย May 2023 amending Directiveย 2011/65/EU of the European Parliament and of the Council as regards an exemption for lead as a thermal stabilizer in polyvinyl chloride used as base material in sensors used in in vitro diagnostic medical devices (Official Journal of the European Union L 185 of 24ย July 2023) From European Parliament ๐ช๐บ Corrigendum to Commission Delegated Directive (EU) 2023/1526 amending Directive 2011/65/EU regarding lead exemption in 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 27, 2023 Creative Commons Attribution 4.0 0 reuses 0 favorites
Requirements of Importation and Re-Exportation for Radioactive Materials Used in Medical Applications (MDS-REQ6) From Saudi Food and Drug Authority (SFDA) ๐ธ๐ฆ Radioactive materials importation and re-exportation requirements. 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 18, 2023 Other (Public Domain) 0 reuses 0 favorites
List of ventilators, CPAP, and BiPAP devices unaffected by foam material From Therapeutic Goods Administration (TGA) ๐ฆ๐บ The TGA is reviewing all ventilators, CPAP, and BiPAP devices in the ARTG to clarify what devices incorporate sound abatement features. 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 Other (Non-Commercial) 0 reuses 0 favorites