Medical device reforms: benchmarking against international assessment timeframes From Therapeutic Goods Administration (TGA) 🇦🇺 Medical device assessment timeframes should be comparable to overseas regulators. 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 1 month ago Other (Non-Commercial) 0 reuses 0 favorites
Use of international assessments From Therapeutic Goods Administration (TGA) 🇦🇺 Sometimes we use assessments from comparable overseas regulators and international assessment bodies. 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 24, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Authorization to Open Overseas Manufacturer Account Form From Saudi Food and Drug Authority (SFDA) 🇸🇦 A form for authorizing the opening of an overseas manufacturer account. 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 May 5, 2024 Other (Public Domain) 0 reuses 0 favorites
Overseas regulatory evidence options for a medical device application From Therapeutic Goods Administration (TGA) 🇦🇺 You may be able to use overseas evidence to have your medical device included 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 May 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Australian manufacturing licences and overseas GMP certification From Therapeutic Goods Administration (TGA) 🇦🇺 A step-by-step guide for Australian manufacturers of therapeutic goods. 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 April 3, 2024 Other (Non-Commercial) 0 reuses 0 favorites
GMP clearance guidance From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance for sponsors seeking to obtain Good Manufacturing Practice (GMP) clearance for an overseas manufacturing site. 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 11, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Use of market authorisation evidence from comparable overseas regulators and assessment bodies for medical devices (including IVDs) From Therapeutic Goods Administration (TGA) 🇦🇺 For abridgement of TGA conformity assessments and as information required for applications for ARTG inclusion 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 November 13, 2023 Other (Non-Commercial) 0 reuses 0 favorites
International cooperation From Therapeutic Goods Administration (TGA) 🇦🇺 The TGA works closely with overseas regulatory agencies and has a number of agreements with them. 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 21, 2023 Other (Non-Commercial) 0 reuses 0 favorites
International activities From Therapeutic Goods Administration (TGA) 🇦🇺 As an internationally-respected regulator, the TGA is involved in many activities with overseas organisations. 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 21, 2023 Other (Non-Commercial) 0 reuses 0 favorites
The TGA's approach to delays in medical device conformity assessment recertification From Therapeutic Goods Administration (TGA) 🇦🇺 Our approach to delays in overseas and Australian conformity assessment recertifications due to the COVID-19 pandemic and the implementation of the EU MDR/IVDR. 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 28, 2023 Other (Non-Commercial) 0 reuses 0 favorites
List of Comparable Overseas Bodies (COBs) From Therapeutic Goods Administration (TGA) 🇦🇺 The TGA will consider evaluation reports from the bodies specified in Table 1 for use in the COB report-based process. 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 1, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Comparable overseas regulators for medical device applications From Therapeutic Goods Administration (TGA) 🇦🇺 Use of market authorisation evidence from comparable overseas regulators for 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 October 7, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Medical device reforms: Comparable overseas regulator marketing approvals From Therapeutic Goods Administration (TGA) 🇦🇺 Marketing approvals and certificates from comparable overseas regulators can be considered for TGA approvals. 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 11, 2021 Other (Non-Commercial) 0 reuses 0 favorites
List of countries and jurisdictions determined to be comparable overseas regulators (CORs) From Therapeutic Goods Administration (TGA) 🇦🇺 List of countries and jurisdictions determined to be comparable overseas regulators (CORs) 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 October 24, 2019 Other (Non-Commercial) 0 reuses 0 favorites
Comparable overseas regulators (CORs): Submission requirements From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance on the submission requirements for the prescription medicines COR report-based process. 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 October 24, 2019 Other (Non-Commercial) 0 reuses 0 favorites
Q&A: Use of market authorisation evidence from comparable overseas regulatory bodies for medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Additional Q&A's on use of market authorisation evidence from overseas regulatory bodies 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 August 29, 2019 Other (Non-Commercial) 0 reuses 0 favorites
Sponsor responsibilities related to GMP clearance and certification From Therapeutic Goods Administration (TGA) 🇦🇺 This guidance is for sponsors of medicines manufactured overseas 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 4, 2017 Other (Non-Commercial) 0 reuses 0 favorites
Metal-on-metal hip replacement implants From Therapeutic Goods Administration (TGA) 🇦🇺 Overseas advice for general practitioners, orthopaedic surgeons and other health professionals on metal-on-metal hip replacement 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 July 14, 2017 Other (Non-Commercial) 0 reuses 0 favorites
Notice on the operational procedures related to the provision of copies of registered product standards for domestic Class III and overseas medical devices to manufacturing enterprises From National Medical Products Administration (NMPA) 🇨🇳 FGWJ-2005-10014 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 5, 2005 Other (Public Domain) 0 reuses 0 favorites