21 CFR Chapter I Subchapter H β Medical Devices β Part 880 General Hospital and Personal Use Devices From Food and Drug Administration (FDA) πΊπΈ 21 CFR Chapter I Subchapter H - Medical Devices - Part 880 General Hospital and Personal Use Devices. Regulation. 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 August 19, 2024 Other (Public Domain) 0 reuses 0 favorites
Disinfectants, sterilants and sanitary products From Therapeutic Goods Administration (TGA) π¦πΊ How sterilants and disinfectants are regulated in Australia. List of relevant legislation. 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 5, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Submissions received: Proposal for clarifying the regulation of residual-activity claims for disinfectants From Therapeutic Goods Administration (TGA) π¦πΊ Submissions published and summarised as part of a consultation on clarifying the regulation of 'residual activity' claims for disinfectants. 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 13, 2024 Other (Non-Commercial) 0 reuses 0 favorites
DR4 From Therapeutic Goods Administration (TGA) π¦πΊ Device Requirements version 4 (DR4) provides guidance on transition arrangements for 'retained registered disinfectants' regulated under the pre- 4 October 2002 regulatory framework for 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 April 4, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guidance on the regulation of exempt disinfectants in Australia From Therapeutic Goods Administration (TGA) π¦πΊ Information on how exempt disinfectants are defined and meeting the regulatory requirements for their manufacture, supply and advertising. 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
Evaluation of sterilants and disinfectants From Therapeutic Goods Administration (TGA) π¦πΊ These historical guidelines describe the information to be supplied for the registration or listing of disinfectants and sterilants in the Australian Register of Therapeutic Goods (ARTG). 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 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
COVID-19 health product industry From Health Canada π¨π¦ Links to COVID-19-related information for health product manufacturers and distributors of diagnostic tests, ventilators, hand sanitizers and disinfectants. 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 15, 2023 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Changes to labelling and regulation of hard surface disinfectants (commencing 1 April 2019) From Therapeutic Goods Administration (TGA) π¦πΊ TGA instructions for disinfectant testing. 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 12, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Regulation of listed disinfectants in Australia From Therapeutic Goods Administration (TGA) π¦πΊ How the Therapeutic Goods Administration (TGA) defines and regulates listed disinfectants, including guidance on how to submit a product application and the supporting data and other information required. 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 6, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Disinfectant Claim Guide: specific claims and non-specific claims From Therapeutic Goods Administration (TGA) π¦πΊ 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
Surrogate viruses for use in disinfectant efficacy tests to justify claims against COVID-19 From Therapeutic Goods Administration (TGA) π¦πΊ Frequently asked questions added 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 7, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Disinfectants: FAQ for new sponsors From Therapeutic Goods Administration (TGA) π¦πΊ Answers to frequently asked questions in relation to the supply of disinfectant products. 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 December 20, 2021 Other (Non-Commercial) 0 reuses 0 favorites
TGA instructions for disinfectant testing From Therapeutic Goods Administration (TGA) π¦πΊ Information on testing of disinfectants and sterilants so they meet quality, safety and efficacy requirements specified in Therapeutic Goods Order 104. 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 3, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Regulation of borderline disinfectant and related products with antiviral claims including COVID-19 From Therapeutic Goods Administration (TGA) π¦πΊ Information to assist sponsors and manufacturers of products making antiviral claims determine if their products requires an entry in the Australian Register of Therapeutic Goods (ARTG) to be legally imported and/or supplied 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 2, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Regulation of cleaners and disinfectants: Information for sponsors and manufacturers From Therapeutic Goods Administration (TGA) π¦πΊ There is significant interest from potential sponsors and manufacturers to understand how disinfectants are regulated and how to supply them 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 26, 2020 Other (Non-Commercial) 0 reuses 0 favorites
Disinfectants: Information for new sponsors From Therapeutic Goods Administration (TGA) π¦πΊ Guidance on how to supply, import, and export of disinfectant products. 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 26, 2020 Other (Non-Commercial) 0 reuses 0 favorites
Appropriate use of disinfectants: Information for consumers, health professionals and healthcare facilities From Therapeutic Goods Administration (TGA) π¦πΊ We have identified disinfectants as being critical in preventing the spread of COVID-19 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 26, 2020 Other (Non-Commercial) 0 reuses 0 favorites
Content and Format of Premarket Notification [510(k)] Submissions for Liquid Chemical Sterilants/High Level Disinfectants - Guidance for Industry and FDA Reviewers From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for industry and FDA reviewers on the content and format of premarket notification submissions for liquid chemical sterilants/high level disinfectants. 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 18, 2020 Other (Public Domain) 0 reuses 0 favorites
Guidance document - Safety and effectiveness requirements for high-level disinfectants and sterilants for use on reusable semi-critical and critical medical devices (2018) From Health Canada π¨π¦ 2014 Health Canada guidance document - outlines the information considered necessary to support the safety and efficacy of chemical products that are represented for use as high-level disinfectants and sterilants on reusable semi-critical and critical medical devices, which are regulated as drugsβ¦ 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 16, 2018 Open Government License 2.0 (Canada) 0 reuses 0 favorites
Guidance document - Safety and Effectiveness Requirements for Contact Lens Disinfectants (2018) From Health Canada π¨π¦ 2014 Health Canada guidance document - This guidance document outlines the information considered necessary to support the safety and efficacy of contact lens disinfectants, which are regulated as drugs under the Food and Drugs Act and 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 March 16, 2018 Open Government License 2.0 (Canada) 0 reuses 0 favorites