IMDRF Document Implementation Report From International Medical Device Regulators Forum (IMDRF) π IMDRF Document Implementation Report 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 1 week ago Other (Public Domain) 0 reuses 0 favorites
IMDRF Standard Operating Procedures From International Medical Device Regulators Forum (IMDRF) π Procedural document: IMDRF/MC/N2 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 July 4, 2024 Other (Public Domain) 0 reuses 0 favorites
Non-In Vitro Diagnostic Device Regulatory Submission Table of Contents (nIVD ToC) From International Medical Device Regulators Forum (IMDRF) π IMDRF/RPS WG/N9 Final:2024 (Edition 4) 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 June 25, 2024 Other (Public Domain) 0 reuses 0 favorites
In Vitro Diagnostic Medical Device Regulatory Submission Table of Contents (IVD ToC) From International Medical Device Regulators Forum (IMDRF) π Technical document: IMDRF/RPS WG/N13 FINAL:2024 (Edition 4) 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 June 25, 2024 Other (Public Domain) 0 reuses 0 favorites
International Medical Device Regulators Forum (IMDRF) From Therapeutic Goods Administration (TGA) π¦πΊ The TGA was a founding member of the IMDRF. The IMDRF promotes an efficient and effective medical devices sector. 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
Slide Template for IMDRF Membership Application Presentations From International Medical Device Regulators Forum (IMDRF) π Slide Template (MS PowerPoint) to assist in the development of presentations by Regulatory Authorities making IMDRF Membership Applications 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 20, 2024 Other (Public Domain) 0 reuses 0 favorites
IMDRF 25th Session Workshop: White Paper on Reliance From International Medical Device Regulators Forum (IMDRF) π IMDRF 25th Session Workshop: White Paper on Reliance 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 May 3, 2024 Other (Public Domain) 0 reuses 0 favorites
Principles of Labelling for Medical Devices and IVD Medical Devices From International Medical Device Regulators Forum (IMDRF) π Technical document: IMDRF/GRRP WG/N52 FINAL:2024 (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 April 26, 2024 Other (Public Domain) 0 reuses 0 favorites
Medical Device Regulatory Review Report: Guidance Regarding Information to be Included From International Medical Device Regulators Forum (IMDRF) π Medical Device Regulatory Review Report: Guidance Regarding Information to be Included - Initial Release 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 April 26, 2024 Other (Public Domain) 0 reuses 0 favorites
Essential Principles of Safety and Performance of Medical Devices and IVD Medical Devices From International Medical Device Regulators Forum (IMDRF) π Technical document: IMDRF/GRRP WG/N47 FINAL:2024 (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 April 26, 2024 Other (Public Domain) 0 reuses 0 favorites
Competence, Training, and Conduct Requirements for Regulatory Reviewers From International Medical Device Regulators Forum (IMDRF) π Technical document: IMDRF/GRRP WG/N40 FINAL:2024 (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 April 26, 2024 Other (Public Domain) 0 reuses 0 favorites
IMDRF 25th MC Meeting Washington March 2024 - Outcome Statement From International Medical Device Regulators Forum (IMDRF) π IMDRF 25th MC Meeting Washington March 2024 - Outcome Statement 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 March 28, 2024 Other (Public Domain) 0 reuses 0 favorites
Terminologies for Categorized Adverse Event Reporting (AER): terms, terminology and codes From International Medical Device Regulators Forum (IMDRF) π Technical document: IMDRF/AE WG/N43FINAL:2020 (Edition 4) - Annexes and release notes updated annually Current release: IMDRF/AE WG/N43FINAL:2024 Updated Annexes 20 April 2024; Annex A_1 β updated 9 May 2024 (refer release notes for details) 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 March 7, 2024 Other (Public Domain) 0 reuses 0 favorites
GN-18 R3 Guidance on Preparation of a Product Registration Submission for IVD MD using the ASEAN CSDT (2024 Mar) PUB From Health Sciences Authority (HSA) πΈπ¬ Guidance document on preparing a product registration submission for IVD MD using ASEAN CSDT. 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 March 1, 2024 Other (Public Domain) 0 reuses 0 favorites
GN-17 R3 Guidance on Preparation of a Product Registration Submission for GMD using the ASEAN CSDT (2024 Mar) PUB From Health Sciences Authority (HSA) πΈπ¬ Provides guidance on preparing a product registration submission for GMD using the ASEAN CSDT. 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 March 1, 2024 Other (Public Domain) 0 reuses 0 favorites
IMDRF Terms of Reference From International Medical Device Regulators Forum (IMDRF) π Procedural document: IMDRF/MC/N1 FINAL:2024 (Edition 7) 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 February 8, 2024 Other (Public Domain) 0 reuses 0 favorites
Guiding Principles to Support Medical Device Health Equity From International Medical Device Regulators Forum (IMDRF) π IMDRF/MC/N79 - Guiding Principles to Support Medical Device Health Equity 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 February 8, 2024 Other (Public Domain) 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
IMDRF Working Group Membership Application Form From International Medical Device Regulators Forum (IMDRF) π IMDRF Working Group Membership Application Form 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 October 31, 2023 Other (Public Domain) 0 reuses 0 favorites
IMDRF Membership Application Form From International Medical Device Regulators Forum (IMDRF) π Procedural document: IMDRF/MC/N69 FINAL:2023 (Edition 8) 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 October 31, 2023 Other (Public Domain) 0 reuses 0 favorites