21 CFR Chapter I Subchapter H β Medical Devices β Part 866 Immunology and Microbiology Devices From Food and Drug Administration (FDA) πΊπΈ Regulation on Immunology and Microbiology Devices under 21 CFR Chapter I Subchapter H - Medical Devices, Part 866. Metadata quality: Metadata quality: Data description filled Files documented License filled Update frequency followed File formats are open Temporal coverage not set Spatial coverage filled All files are available Learn more about this indicator Metadata quality: 88.88888888888889/100 Updated 1 day ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 876 Gastroenterology-Urology Devices From Food and Drug Administration (FDA) πΊπΈ Regulation on Gastroenterology-Urology Devices under 21 CFR Chapter I Subchapter H - Medical Devices, Part 876. 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 2 days ago Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 880 General Hospital and Personal Use Devices From Food and Drug Administration (FDA) πΊπΈ 21 CFR Chapter I Subchapter H - Medical Devices - Part 880 General Hospital and Personal Use Devices. Regulation. 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 August 19, 2024 Other (Public Domain) 0 reuses 0 favorites
Pre-submission Advice & Support From Medicines and Healthcare products Regulatory Agency (MHRA) π¬π§ The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations. 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 13, 2024 Open Government Licence 2.0 (United Kingdom) 0 reuses 0 favorites
Medical device conformity assessment application From Therapeutic Goods Administration (TGA) π¦πΊ Information and forms about applications for TGA conformity assessment certificates. 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
New pilot programme to support orphan medical devices From European Medicines Agency (EMA) πͺπΊ Announcement of a new pilot programme aimed at providing support for orphan 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 August 2, 2024 Other (Public Domain) 0 reuses 0 favorites
Support swissdamed From Swiss Agency for Therapeutic Products (Swissmedic) π¨π Document providing support and information on the topic of "swissdamed". 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 19, 2024 Other (Non-Commercial) 0 reuses 0 favorites
ICH harmonised guideline - Nonclinical safety testing in support of development of paediatric pharmaceuticals From Therapeutic Goods Administration (TGA) π¦πΊ We have adopted this International Scientific Guideline- ICH S11 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 17, 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
Regulation impact statement: Proposed regulatory scheme for personalised medical devices, including 3D-printed devices From Therapeutic Goods Administration (TGA) π¦πΊ 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
SFDA Recognized Standards (Supporting Medical Device Premarket Submissions) From Saudi Food and Drug Authority (SFDA) πΈπ¦ This document provides guidance on SFDA recognized standards for medical device premarket submissions. 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 May 21, 2024 Other (Public Domain) 0 reuses 0 favorites
21 CFR Chapter I Subchapter H β Medical Devices β Part 868 Anesthesiology Devices From Food and Drug Administration (FDA) πΊπΈ This document is a regulation titled "21 CFR Chapter I Subchapter H β Medical Devices β Part 868 Anesthesiology Devices". 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 May 21, 2024 Other (Public Domain) 0 reuses 0 favorites
UDI Webinars From Therapeutic Goods Administration (TGA) π¦πΊ UDI webinars cover a range of topics including introductory UDI information, adoption in healthcare and software support for UDI. 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 7, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Statutory advisory committee forms From Therapeutic Goods Administration (TGA) π¦πΊ This form is to be submitted with the expression of interest when applying for membership to a TGA expert committee. 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 22, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Overview of Unique Device Identification for Australian Healthcare From Therapeutic Goods Administration (TGA) π¦πΊ This document supports UDI awareness and adoption in Australian healthcare settings 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 15, 2024 Other (Non-Commercial) 0 reuses 0 favorites
Leveraging Existing Clinical Data for Extrapolation to Pediatric Uses of Medical Devices: Guidance for Industry and Food and Drug Administration Staff From Food and Drug Administration (FDA) πΊπΈ This document provides guidance for leveraging clinical data to support the use of medical devices in pediatric populations. 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 8, 2024 Other (Public Domain) 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
Guidance for Additional Considerations to support Conformity Assessment of In vitro Companion Diagnostic Medical Devices From Ministry of Food and Drug Safety (MFDS) π°π· Guidance for Additional Considerations to support Conformity Assessment of In vitro Companion Diagnostic 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 March 29, 2024 Other (Public Domain) 0 reuses 0 favorites
Supporting documentation for inclusion of a medical device From Therapeutic Goods Administration (TGA) π¦πΊ Information on documents that may be required depending on the classification and kind of device (including IVDs) 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