Submissions received: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices From Therapeutic Goods Administration (TGA) 🇦🇺 The TGA thanks respondents who provided a submission in response to the public consultation paper 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 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Submissions received: Proposed refinements to the regulation of personalised medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 The TGA thanks respondents who provided a submission in response to the public consultation paper Proposed refinements to the regulation of personalised 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 June 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices From Therapeutic Goods Administration (TGA) 🇦🇺 Regulation Impact Statement in support of proposed reforms around personalised 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 June 25, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Personalised medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Links to information on personalised medical devices (including custom-made, patient-matched, and adaptable 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 May 1, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Guidance for dental practitioners From Therapeutic Goods Administration (TGA) 🇦🇺 Information on regulatory requirements for Ahpra registered dental practitioners making and adapting personalised medical devices for patients. 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 23, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Medical devices reforms: Personalised medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance on progress of regulatory refinements to personalised 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 March 21, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Advertising personalised medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 Understand the rules for advertising therapeutic goods to 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 January 30, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Refinements to the Personalised Medical Device Framework From Therapeutic Goods Administration (TGA) 🇦🇺 Guidance to assist sponsors and manufacturers comply with new regulations. 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 17, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Personalised medical devices (including 3D-printed devices) From Therapeutic Goods Administration (TGA) 🇦🇺 Information and examples to help you understand the regulatory framework for personalised 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 December 15, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Personalized Medical Devices - Regulatory Pathways From International Medical Device Regulators Forum (IMDRF) 🌍 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
TGA leads IMDRF work on personalised medical devices From Therapeutic Goods Administration (TGA) 🇦🇺 The IMDRF Personalized Medical Devices Working Group met to progress their guidance document on the regulation of personalised 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 8, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Regulatory framework for personalised medical devices: Frequently asked questions From Therapeutic Goods Administration (TGA) 🇦🇺 Frequently asked questions to further clarify the new regulatory framework for personalised 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 May 9, 2023 Other (Non-Commercial) 0 reuses 0 favorites
Personalized Medical Devices – Production Verification and Validation From International Medical Device Regulators Forum (IMDRF) 🌍 Personalized Medical Devices – Production Verification and Validation (N74) 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 April 11, 2023 Other (Public Domain) 0 reuses 0 favorites
Presentation: Personalised medical device framework, 12 May 2022 From Therapeutic Goods Administration (TGA) 🇦🇺 Presentation on medical device regulations. 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 20, 2022 Other (Non-Commercial) 0 reuses 0 favorites
Collegiate Board Resolution - RDC No. 305 of 24/09/2019 From Brazilian Health Regulatory Agency (Anvisa) 🇧🇷 Provides requirements for the manufacture, marketing, import and exposure to use of personalized medical devices. Metadata quality: Metadata quality: Data description filled 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: 66.66666666666666/100 Updated on September 25, 2019 Other (Public Domain) 0 reuses 0 favorites
Definitions for Personalized Medical Devices From International Medical Device Regulators Forum (IMDRF) 🌍 Technical document: IMDRF/PMD WG/N49FINAL:2018 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 November 7, 2018 Other (Public Domain) 0 reuses 0 favorites