№ lp_1_2_23650
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Report summarizing the implementation status of IMDRF technical documents and oversight of previously published GHTF documents across multiple countries and regions.
Year:
2025
Organization:
International Medical Device Regulators Forum (IMDRF)
Type:
Implementation Report
Authors:
IMDRF Management Committee, Authoring Group
Scope:
International medical device regulatory convergence
Document Series:
IMDRF/MC/N84
Related Documents:
IMDRF technical documents, GHTF documents
Implementation Status Categories:
Implemented, Partly Implemented, Not Implemented, Not Applicable
Countries Covered:
Brazil, Canada, China, EU, Japan, Russia, Singapore, Switzerland, USA, Argentina, Saudi Arabia, Australia, South Korea, UK
Audience:
Regulatory authorities and stakeholders in medical device regulation
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Year:
2019
Region / City:
International
Subject:
Medical device adverse event reporting
Document Type:
Proposed document
Organ / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF Adverse Event Terminology Working Group
Intended Audience:
Regulatory authorities, healthcare providers, manufacturers, reporters of adverse events
Period of validity:
Not specified
Approval date:
27th June 2019
Date of Changes:
Not specified
Year:
2020
Region / City:
International
Topic:
Medical device regulation
Document Type:
Final Document
Organization / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF Adverse Event Terminology Working Group
Intended Audience:
Regulatory authorities, medical device manufacturers, healthcare providers
Period of Validity:
Not specified
Approval Date:
18 March 2020
Date of Changes:
Not specified
Year:
2018
Region / city:
International
Topic:
Medical device regulation
Document type:
Proposed document
Organization / institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF UDI WG
Target audience:
Medical device regulators
Period of validity:
Ongoing
Approval date:
12 July 2018
Date of changes:
None
Year:
2014
Region / City:
International
Topic:
Medical Device Submissions
Document Type:
Guidance Document
Organization / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF RPS ToC Working Group
Target Audience:
Medical device industry, regulatory authorities
Implementation Period:
Pre-RPS electronic submission environment
Approval Date:
30 June 2014
Amendment Date:
Not specified
Year:
2015
Region / city:
International
Theme:
Medical device regulation, pilot program
Document type:
Final document
Organization / institution:
International Medical Device Regulators Forum (IMDRF)
Author:
Toshiyoshi Tominaga, IMDRF Chair
Target audience:
Medical device regulators, industry participants
Period of validity:
2015-2016
Date of approval:
8 July 2015
Date of revisions:
N/A
Document Number:
IMDRF/RPS WG (PD1)/N27R2
Status:
Proposed Document
Organization:
International Medical Device Regulators Forum
Authoring Group:
Regulated Product Submissions Table of Contents Working Group
Date:
17 September 2015
Subject:
Medical device regulatory submissions
Scope:
Assembly of IMDRF Table of Contents (ToC) based submissions
Related Standard:
Health Level Seven (HL7) Regulated Product Submission Standard
Related Documents:
IMDRF In Vitro Diagnostic Medical Device Market Authorization Table of Contents (IVD MA ToC); IMDRF Non-In Vitro Diagnostic Medical Device Market Authorization Table of Contents (nIVD MA ToC); IMDRF Standard ToC Folder Structure; IMDRF Frequently Asked Questions Document
Submission Types:
Non-IVD Market Authorization; IVD Market Authorization
Participating Regions:
ANVISA; EU; Health Canada; TGA; USFDA; CFDA
Language:
English
Access:
No restrictions on reproduction, distribution or use
Year:
2021
Region / City:
International
Topic:
Medical Device Regulation
Document Type:
Standard Operating Procedures
Organization:
International Medical Device Regulators Forum
Author:
IMDRF Management Committee
Target Audience:
Regulatory Authorities, Medical Device Regulators
Effective Period:
Ongoing
Approval Date:
25 March 2021
Modification Date:
Not specified
Year:
2019
Location:
New Delhi, India
Type of document:
Technical Proposal
Organization:
ITU-T Focus Group on AI for Health, WG-DAISAM
Authors:
Luis Oala, Pradeep Balachandran, Pat Baird, Thomas Wiegand
Target audience:
Regulators, AI for health developers, medical device manufacturers
Period:
2017-2020
Document status:
Draft
Contact emails:
[email protected]; [email protected]; [email protected]; [email protected]
Abstract:
Provides a mapping of IMDRF Essential Principles to aspects of AI for health software
Keywords:
AI4H, IMDRF, SaMD, Regulatory framework, Risk management, Performance evaluation
Year:
2020
Region / Organization:
IMDRF
Subject:
Medical Device Adverse Event Terminology
Document Type:
Coding Guide / Terminology Reference
Annexes Covered:
A, B, C, D, E, F, G
Authoring Group:
IMDRF AE Working Group
Audience:
Medical device regulators, terminology specialists
Hierarchy Details:
Terms in Annex A, C, D, F, G occur once; Annex B has no hierarchy; Annex E terms may appear at multiple levels
Columns Included:
Level 1 Term, Level 2 Term, Level 3 Term, Code, CodeHierarchy, Definition, Non-IMDRF Code/Term, Status, Status Description, Primary Category, Secondary Category (E only)
Purpose:
Standardizing term definitions and hierarchical coding for adverse events in medical devices
Note:
Year
Subject:
Food safety
Document type:
Standard
Agency / institution:
Tanzania Bureau of Standards (TBS)
Year:
2024-25
Region / City:
Local Government Victoria
Theme:
Performance Reporting
Document Type:
Guide
Organization:
Local Government Victoria
Author:
Not specified
Target Audience:
Local government councils and relevant departments
Effective Period:
2024-25
Approval Date:
Not specified
Date of Changes:
2022-23 amendments to regulations
Year:
2025
Note:
Region / City
Topic:
Accessibility, Software Compliance
Document Type:
Accessibility Report
Organization / Institution:
The MathWorks, Inc.
Year:
2023
Region / City:
N/A
Subject:
English Language Arts
Document Type:
Lesson Plan
Institution:
N/A
Author:
N/A
Target Audience:
Middle School Students
Period of Validity:
N/A
Approval Date:
N/A
Date of Modifications:
N/A
Year:
2025-26
Region / City:
Victoria
Theme:
Local Government Performance Reporting
Document Type:
Guide
Institution:
Local Government Victoria
Author:
Local Government Victoria
Target Audience:
Local government councils, public administrators
Period of Validity:
2025-26
Approval Date:
October 2022
Date of Amendments:
October 2022
Revision Date:
January 2020
Region / City:
Global
Theme:
Procurement, Environmental and Social Performance
Document Type:
Standard Bidding Document
Organ / Institution:
World Bank
Author:
World Bank
Target Audience:
Contractors, Bidders, World Bank Borrowers
Period of Validity:
Ongoing
Approval Date:
January 2020
Date of Changes:
January 2020
Note:
Year
Year:
2025
Publication Date:
November 2025
Product Name:
Anthology Blackboard
Version:
4000.1
Audit Period:
August 2025
Type:
Accessibility Conformance Report
Standards:
WCAG 2.0, 2.1, 2.2; Revised Section 508; EN 301 549
Contact:
Wade Weichel, Senior Director, Product Management, [email protected]
Evaluation Methods:
Internal accessibility audit using manual and automated testing, assistive technology, and representative workflows
Tools:
NVDA, Google Chrome, Axe Dev Tools, WebAim’s Contrast Checker, browser inspection tools, Stylus browser extension
Target Users:
Instructors and students
Scope:
Full pages, complete processes, and accessibility-supported ways of using technology
Year:
2026
Region / City:
United States
Topic:
Law Firm Practice Areas
Document Type:
Survey/Form
Organization:
Legal 500
Author:
Legal 500
Target Audience:
Law Firms
Effective Period:
2026
Approval Date:
N/A
Amendment Date:
N/A
Philippine Bidding Documents Republic of the Philippines Procurement of Goods First Edition May 2025
Year:
2025
Region / City:
Philippines
Theme:
Procurement of Goods
Document Type:
Bidding Documents
Institution:
Government of the Philippines (GoP)
Target Audience:
Government branches, agencies, departments, bureaus, offices, instrumentalities, including government-owned corporations, government financial institutions, state universities, colleges, and local government units (LGUs)
Contract Duration:
Not specified
Approval Date:
Not specified
Amendment Date:
Not specified
Period of Validity:
Not specified
Year:
2023
Region / city:
United Kingdom
Subject:
Psychological wellbeing, mental health training, NHS Talking Therapies
Document Type:
Curriculum
Organization / Institution:
NHS
Author:
NHS
Target Audience:
Trainees, mental health professionals, educators
Period of Validity:
Not specified
Approval Date:
July 2022
Date of Revisions:
April 2023