Notice on Medical Devices From National Organization for Medicines (EOF) ๐ฌ๐ท Notice concerning products applied to the skin with health claims (muscle pain, joint pain, etc.), containing camphor and/or ... 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 1, 2024 Other (Public Domain) 0 reuses 0 favorites
Submissions received: Proposal for clarifying the regulation of residual-activity claims for disinfectants From Therapeutic Goods Administration (TGA) ๐ฆ๐บ 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
Guidance on exemptions from the requirement to perform clinical investigations pursuant to Article 61(4)-(6) MDR and on sufficient levels of accessโ to data needed to justify claims of equivalence From European Commission ๐ช๐บ Document provides guidance on exemptions from clinical investigations under MDR Article 61(4)-(6) and access to data for claims of equivalence. 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 23, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Reporting system for in vitro diagnostic medical devices From Ministry of Health (Italy) (MDS) ๐ฎ๐น The Ministry of Health carries out the activities of monitoring and investigating reports from healthcare professionals and manufacturers. On Sept. 28, 2022, Legislative Decree No. 138 of Aug. 5, 2022 , came into force, which in Article 13 provides fulfillments for manufacturers of in vitroโฆ 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 3, 2023 Creative Commons Attribution 3.0 0 reuses 0 favorites
Using scientific or clinical claims (representations) in therapeutic goods advertising From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Understanding the requirements of Section 11 of the Therapeutic Goods Advertising Code. 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 February 22, 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
Surrogate viruses for use in disinfectant efficacy tests to justify claims against COVID-19 From Therapeutic Goods Administration (TGA) ๐ฆ๐บ 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
Presentation: TGA evidence expectations for medical devices or surfaces with anti-viral or anti-microbial claims, 2 March 2022 From Therapeutic Goods Administration (TGA) ๐ฆ๐บ General regulatory requirements of medical devices, what antiviral claims can be made and types of evidence 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 May 16, 2022 Other (Non-Commercial) 0 reuses 0 favorites
The claim 'TGA approved' must not be used in advertising From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Guidance for advertising - claims such as 'TGA approved' must not be used in advertisements for 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 September 13, 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) ๐ฆ๐บ 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
Declaring a product that claims total inactivation against NTCAs From National Agency for the Safety of Medicines and Health Products (ANSM) ๐ซ๐ท Procedure Declaring a product claiming total inactivation against NTCAs 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 22, 2021 Other (Non-Commercial) 0 reuses 0 favorites
List of inactivating products and file format for inactivation performance claims From National Agency for the Safety of Medicines and Health Products (ANSM) ๐ซ๐ท Procedure List of inactivating products and file format for claiming inactivation performance 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 1, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Patient-Reported Outcome Measures: Use in Medical Product Development to Support Labeling Claims: Guidance for Industry From Food and Drug Administration (FDA) ๐บ๐ธ A guidance document on using patient-reported outcome measures in medical product development to support labeling claims. 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 15, 2020 Other (Public Domain) 0 reuses 0 favorites
Noise Claims in Hearing Aid Labeling - Guidance for Industry From Food and Drug Administration (FDA) ๐บ๐ธ Guidance document on labeling of hearing aids, addressing noise claims and premarket requirements for the industry. 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
Therapeutic goods advertising: Ensuring 'natural' claims are not misleading From Therapeutic Goods Administration (TGA) ๐ฆ๐บ Guidance on how advertisers can use terms such as 'natural' without misleading consumers. 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 11, 2019 Other (Non-Commercial) 0 reuses 0 favorites
Reporting Information Regarding Falsification of Data From Food and Drug Administration (FDA) ๐บ๐ธ Document number 2010-3123. The Food and Drug Administration (FDA) is proposing to amend its regulations to require sponsors to report information indicating that any person has, or may have, engaged in the falsification of data in the course of reporting study results, or in the course ofโฆ 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 19, 2010 Other (Public Domain) 0 reuses 0 favorites
Notice to manufacturers on the marketing of nasal sprays claiming virucidal and antimicrobial actions From Health Products Regulatory Authority (HPRA) ๐ฎ๐ช A notice addressing manufacturers about marketing nasal sprays with virucidal and antimicrobial 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 May 8, 2024 Other (Public Domain) 0 reuses 0 favorites