Medical devices reforms: priority review pathway From Therapeutic Goods Administration (TGA) π¦πΊ Priority review can provide faster access to 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 1 month ago Other (Non-Commercial) 0 reuses 0 favorites
List of Ventilators, CPAP, and BiPAP devices containing PE-PUR foam material in the breathing gas pathway From Therapeutic Goods Administration (TGA) π¦πΊ The TGA has identified additional devices (other than those supplied by Philips Electronics Australia Ltd) that contain PE-PUR foam material for sound abatement purpose in the breathing gas pathway. 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 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Exporting a ventilator From Therapeutic Goods Administration (TGA) π¦πΊ Information for sponsors and manufacturers about pathways for exporting a ventilator from Australia. 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 10, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Provisional approval pathway From Therapeutic Goods Administration (TGA) π¦πΊ Information on how to register a prescription medicine under the provisional approval pathway. 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 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Priority review pathway From Therapeutic Goods Administration (TGA) π¦πΊ The priority pathway provides a formal mechanism for faster assessment of vital and life saving prescription medicines. 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 27, 2024 Other (Non-Commercial) 0 reuses 0 favorites
The Target Development Profile Toolkit From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines. 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 5, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Innovative Licensing and Access Pathway From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access. 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 5, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
The Innovative Devices Access Pathway (IDAP) From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market. 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 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Authorised Prescriber established history of use lists From Therapeutic Goods Administration (TGA) π¦πΊ Lists of medicines you can access through the established history of use pathway as an Authorised Prescriber. 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 January 15, 2024 Other (Non-Commercial) 0 reuses 0 favorites
IMDRF 24th Session Workshop: White Paper on Specialized Regulatory Pathways From International Medical Device Regulators Forum (IMDRF) π IMDRF 24th Session Workshop White Paper on Specialized Regulatory Pathways Metadata quality: Metadata quality: Data description empty Files documented 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 December 18, 2023 Other (Public Domain) 0 reuses 0 favorites
Priority review pathway for medical devices From Therapeutic Goods Administration (TGA) π¦πΊ Medical device priority review information and application form. 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 November 23, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Personalized Medical Devices - Regulatory Pathways From International Medical Device Regulators Forum (IMDRF) π Technical document: IMDRF/PMD WG/N58 FINAL:2023 (Edition 2) Metadata quality: Metadata quality: Data description empty Files documented 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 September 14, 2023 Other (Public Domain) 0 reuses 0 favorites
Guidance on Clinical Trials Design of Artificial Intelligence(AI)-based Medical Devices From Ministry of Food and Drug Safety (MFDS) π°π· This guidance applies to the regulatory pathways of clinical trial approval, manufacturing, and import licensing (subject to clinical trial data submission) or technical documentation review (subject to clinical trial data submission) for machine learning-enabled medical devices that analyzeβ¦ 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 July 20, 2023 Other (Public Domain) 0 reuses 0 favorites
MHRA / HRA Coordinated pathway From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ The Coordinated pathway process resumed Monday 22 May 2023. 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 9, 2023 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Medical devices (including IVDs) priority applicant determination notices From Therapeutic Goods Administration (TGA) π¦πΊ Medical devices priority applicant determination notices and eligibility for priority review pathway. 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 7, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Priority review pathway for biologicals From Therapeutic Goods Administration (TGA) π¦πΊ Information on the stages of preparation, and application for Class 2, 3 or 4 biologicals using priority pathway. 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 27, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Soft (Hydrophilic) Daily Wear Contact Lenses - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff". It falls under the topic of "Premarket". 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 27, 2023 Other (Public Domain) 0 reuses 0 favorites
Medical Device Accessories - Describing Accessories and Classification Pathways: Guidance for Industry and FDA Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for the medical device industry and FDA staff on describing and classifying medical device accessories. 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 3, 2022 Other (Public Domain) 0 reuses 0 favorites
Facet Screw Systems - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance document titled "Facet Screw Systems - Performance Criteria for Safety and Performance Based Pathway" for premarket review. 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 April 12, 2022 Other (Public Domain) 0 reuses 0 favorites
Denture Base Resins - Performance Criteria for Safety and Performance Based Pathway: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for the industry and FDA staff on safety and performance criteria for denture base resins. 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 April 12, 2022 Other (Public Domain) 0 reuses 0 favorites