Principle 15: Principles applying to IVD medical devices only From Therapeutic Goods Administration (TGA) π¦πΊ Principle 15 covers elements that apply to IVD medical devices. Manufacturers should hold evidence of performance evaluation studies to meet the requirements. 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
Principle 2: Design and construction of medical devices to conform with safety principles From Therapeutic Goods Administration (TGA) π¦πΊ Manufacturers of medical devices must hold evidence that demonstrates that their devices meet the Principles before their devices can be 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 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Manufacturer Evidence for medical devices From Therapeutic Goods Administration (TGA) π¦πΊ Learn how to submit a variation to Manufacturer Evidence 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 18, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Principle 14: Clinical evidence From Therapeutic Goods Administration (TGA) π¦πΊ Principle 14 requires every medical device is supported with clinical evidence. The evidence must show the device meets the relevant Essential Principles. 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 12, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Obtain and maintain regulatory evidence From Therapeutic Goods Administration (TGA) π¦πΊ Understand what evidence is needed to have a 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 June 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Demonstrating compliance with the Essential Principles From Therapeutic Goods Administration (TGA) π¦πΊ Manufacturers are responsible for generating, collating, assessing, and maintaining scientific and engineering evidence that shows that their devices comply with the Essential Principles (the Principles). 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 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Clinical evidence guidelines supplement: In vitro diagnostic (IVD) medical devices From Therapeutic Goods Administration (TGA) π¦πΊ This guidance has been developed to help manufacturers understand how the TGA interprets regulations and how manufacturers can comply with 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 June 17, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Evidence requirements for face masks that are medical devices From Therapeutic Goods Administration (TGA) π¦πΊ How to apply for inclusion of face masks (including respirators), that are medical devices, 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 29, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Ophthalmic Devices; Reclassification of Ultrasound Cyclodestructive Device From Food and Drug Administration (FDA) πΊπΈ Document number 2024-10895. The Food and Drug Administration (FDA, the Agency, or we) is issuing a final order reclassifying the ultrasound cyclodestructive device, a postamendments class III device (product code LZR), into class II (special controls), subject to premarket notification. FDA isβ¦ 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 20, 2024 Other (Public Domain) 0 reuses 0 favorites
Overseas regulatory evidence options for a medical device application From Therapeutic Goods Administration (TGA) π¦πΊ 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 regulatory evidence options for a medical device application From Therapeutic Goods Administration (TGA) π¦πΊ Information on Australian evidence options including TGA conformity assessment certification. 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 May 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Real World Evidence (RWE) From Therapeutic Goods Administration (TGA) π¦πΊ This guidance intends to outline for sponsors and manufacturers the types of RWE relevant in the Australian context. 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 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Real World Evidence (RWE) and patient reported outcomes (PROs) From Therapeutic Goods Administration (TGA) π¦πΊ Latest information about RWE use in regulation of medicines and 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 April 11, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Researcher considerations for medical devices From Therapeutic Goods Administration (TGA) π¦πΊ Guidance to assist researchers who are developing new medical devices understand the evidence requirements for market authorisation 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
Transition to new manufacturer evidence for IVD medical devices From Therapeutic Goods Administration (TGA) π¦πΊ This guidance is to help sponsors and manufacturers of in vitro diagnostic (IVD) medical devices transition to new manufacturer evidence requirements. 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
Manufacturer evidence From Therapeutic Goods Administration (TGA) π¦πΊ Manufacturer evidence 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 12, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Draft: Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices: Draft Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ A draft guidance document on using real-world evidence to support regulatory decision-making for medical devices. 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 7, 2024 Other (Public Domain) 0 reuses 0 favorites
Clinical evidence guidelines From Therapeutic Goods Administration (TGA) π¦πΊ These guidelines provide details and guidance on the clinical evidence requirements for medical devices, including In Vitro Diagnostic medical devices (IVDs), under Australian legislation. 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 23, 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) π¦πΊ 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
Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices : Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document is a guidance for using real-world evidence to support regulatory decisions for medical devices. 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 June 26, 2023 Other (Public Domain) 0 reuses 0 favorites