21 CFR Chapter I Subchapter H β Medical Devices β Part 864 Hematology and Pathology Devices From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 864 Hematology and Pathology 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
Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" : Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on the use of ISO 10993-1 for evaluating and testing medical devices within a risk management process. 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 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 890 Physical Medicine Devices From Food and Drug Administration (FDA) πΊπΈ Regulation on physical medicine devices under 21 CFR Chapter I Subchapter H - Medical Devices - Part 890. 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
The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Labs, and FDA Staff. 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 9, 2024 Other (Public Domain) 0 reuses 0 favorites
ICH harmonised guideline - Nonclinical safety testing in support of development of paediatric pharmaceuticals From Therapeutic Goods Administration (TGA) π¦πΊ We have adopted this International Scientific Guideline- ICH S11 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 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites
ICH guideline S1B(R1) on testing for carcinogenicity of pharmaceuticals From Therapeutic Goods Administration (TGA) π¦πΊ We have adopted this International Scientific Guideline - ICH S1B(R1); EMA/774371/2022 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 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on Stability Testing: Stability Testing of Existing Active Substances and Related Finished Products From Therapeutic Goods Administration (TGA) π¦πΊ We have adopted this International Scientific Guideline - CPMP/QWP/122/02, rev 1 corr 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 16, 2024 Other (Non-Commercial) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 809 In Vitro Diagnostic Products for Human Use From Food and Drug Administration (FDA) πΊπΈ Regulation on in vitro diagnostic products for human use under 21 CFR Chapter I Subchapter H - Medical Devices - Part 809. 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 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Testing of face masks and respirators From Therapeutic Goods Administration (TGA) π¦πΊ Information on TGA laboratory testing of face masks and respirators 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Proposal for a COUNCIL DECISION on the position to be adopted, on behalf of the European Union, within the EEA Joint Committee concerning an amendment to Annex II (Technical regulations, standards, testing and certification) and Protocol 37 (containing the list provided for in Article 101) to the EEA Agreement (Reinforced role for EMA in crisis preparedness and management for medicinal products and medical devices) From European Parliament πͺπΊ A proposal for a decision within the European Union regarding an amendment to technical regulations and protocols in the EEA Agreement for enhanced crisis management in medicinal products and 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 11, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
What are 'therapeutic goods'? From Therapeutic Goods Administration (TGA) π¦πΊ Therapeutic goods can comprise a broad range of things, such as bandages, pregnancy testing kits, herbal remedies, tissue grafts and paracetamol. 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 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guideline on non-clinical testing for inadvertent germline transmission of gene transfer vectors From Therapeutic Goods Administration (TGA) π¦πΊ We have adopted this International Scientific Guideline - EMEA/273974/2005. 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 4, 2024 Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 testing in Australia: information for health professionals From Therapeutic Goods Administration (TGA) π¦πΊ Find information on the different types of COVID-19 tests and how we assess them and monitor their performance. 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 (Non-Commercial) 0 reuses 0 favorites
Guidance on medical/surgical face masks and respirator standards - key performance aspects From Therapeutic Goods Administration (TGA) π¦πΊ Guidance to assist manufacturers in choosing appropriate standards and to set out the TGA's expectations for performance testing 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 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Notice of the Comprehensive Department of the State Drug Administration on the Issuance of the 2024 National Medical Device Sampling and Testing Program for Product Inspection From National Medical Products Administration (NMPA) π¨π³ FGWJ-2024-131 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 March 19, 2024 Other (Public Domain) 0 reuses 0 favorites
Australian code of good manufacturing practice for human blood and blood components, human tissues and human cellular therapy products From Therapeutic Goods Administration (TGA) π¦πΊ The Australian Code of Good Manufacturing Practice (GMP) for Blood and Blood Components, Human Tissues and Human Cellular Therapy Products (the Code) applies to Blood, Human Tissues and Human Cellular Therapy Products manufacturers that undertake the collection, processing, testing, storage,β¦ 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 21, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ A guidance document on testing and labeling medical devices for safety in the magnetic resonance environment. 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 October 10, 2023 Other (Public Domain) 0 reuses 0 favorites
Biocompatibility Testing of Medical Devices - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on biocompatibility testing of medical devices for the ASCA Pilot Program. 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 19, 2023 Other (Public Domain) 0 reuses 0 favorites
Basic Safety and Essential Performance of Medical Electrical Equipment, Medical Electrical Systems, and Laboratory Medical Equipment - Standards Specific Information for the Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program: Guidance for Industry, Accreditation Bodies, Testing Laboratories, and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance on safety and performance standards for medical electrical equipment, systems, and laboratory equipment. 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 19, 2023 Other (Public Domain) 0 reuses 0 favorites
How tests and testing kits for coronavirus (COVID-19) work From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ The different types of tests and testing kits for COVID-19, and the specifications for manufacturers. 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 8, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites