CPG Sec. 160.100 Regulatory Actions and Small Business From Food and Drug Administration (FDA) πΊπΈ CPG Sec. 160.100 provides guidance on regulatory actions and their impact on small businesses. Metadata quality: Metadata quality: Data description empty 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: 55.55555555555556/100 Updated 2 weeks ago Other (Public Domain) 0 reuses 0 favorites
TGA business plan 2024-25 From Therapeutic Goods Administration (TGA) π¦πΊ Read our business plan 2024-25 to find out about our strategic priorities and activities. 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 8, 2024 Other (Non-Commercial) 0 reuses 0 favorites
TGA plans and reports From Therapeutic Goods Administration (TGA) π¦πΊ Browse our corporate business plans, performance frameworks and other corporate reports. 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 6, 2024 Other (Non-Commercial) 0 reuses 0 favorites
TGA reforms From Therapeutic Goods Administration (TGA) π¦πΊ Information on our regulatory and business process reforms. 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 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
MMDR program achievements From Therapeutic Goods Administration (TGA) π¦πΊ We have delivered a raft of reforms, in addition to maintaining core business activities that ensure the high quality regulation of therapeutic goods 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 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
State Drug Administration on the issuance of medical device business quality management standard on-site inspection guidelines notice From National Medical Products Administration (NMPA) π¨π³ FGWJ-2024-10001 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 30, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 822 Postmarket Surveillance From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 822 Postmarket Surveillance". 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
21 CFR Chapter I Subchapter H β Medical Devices β Part 801 Labeling From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β 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
EUDAMED β Technical documentation From European Commission πͺπΊ This document provides technical documentation related to EUDAMED, a system for the exchange of information on medical devices within the EU. 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 17, 2024 Creative Commons Attribution 4.0 0 reuses 0 favorites
Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ Draft guidance document titled "Select Updates for the Medical Device User Fee Small Business Qualification and Certification" for industry 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 not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 55.55555555555556/100 Updated on February 21, 2024 Other (Public Domain) 0 reuses 0 favorites
Advertising guidance for businesses involved with stem cells and other human cell or tissue (HCT) products From Therapeutic Goods Administration (TGA) π¦πΊ Complying with therapeutic goods advertising restrictions. 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 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical Device User Fee Small Business Qualification and Certification: Guidance for Industry, Food and Drug Administration Staff and Foreign Governments From Food and Drug Administration (FDA) πΊπΈ This document provides guidance for small businesses on qualifying and certifying for medical device user fees. 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 17, 2024 Other (Public Domain) 0 reuses 0 favorites
Improving ethics in healthcare delivery From Therapeutic Goods Administration (TGA) π¦πΊ Information related to improving business ethics in healthcare delivery. 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 19, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Advertising guidance for businesses involved with intravenous (IV) vitamin and related therapies From Therapeutic Goods Administration (TGA) π¦πΊ This guidance assists providers of IV drips to understand how to comply with the therapeutic goods advertising requirements 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 December 6, 2023 Other (Non-Commercial) 0 reuses 0 favorites
State Drug Administration Comprehensive Department on the issuance of "medical device business quality management standard appendix: specializing in the provision of medical device transportation and storage services of the enterprise quality management on-site inspection guidelines" notice From National Medical Products Administration (NMPA) π¨π³ FGWJ-2023-10001 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 10, 2024 Other (Public Domain) 0 reuses 0 favorites
Essential Principles: consent for non-compliance From Therapeutic Goods Administration (TGA) π¦πΊ New features have been launched for the Medical Devices Consent for Non-compliance Dashboard in TBS Business Services Portal 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 16, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Reply from the Comprehensive Department of the State Drug Administration on whether automobile sales enterprises operating ambulances containing medical device products should apply for business qualifications From National Medical Products Administration (NMPA) π¨π³ FGWJ-2022-205 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 September 2, 2022 Other (Public Domain) 0 reuses 0 favorites
TGA Business Services: getting started with the TGA From Therapeutic Goods Administration (TGA) π¦πΊ Apply for access and manage your account details. 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, 2021 Other (Non-Commercial) 0 reuses 0 favorites
Comprehensive Department of the State Drug Administration on the "supervision and management of medical devices business approach" Article 54 of the relevant application of the reply letter From National Medical Products Administration (NMPA) π¨π³ FGWJ-2020-10001 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, 2020 Other (Public Domain) 0 reuses 0 favorites
Useful resources for business and researchers From Therapeutic Goods Administration (TGA) π¦πΊ This page helps point you in the right direction of where you might go to receive support and information at different stages of the product lifecycle. 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 11, 2020 Other (Non-Commercial) 0 reuses 0 favorites