№ lp_1_2_55862
File format: docx
Character count: 3229
File size: 56 KB
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
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Year:
2018
Region / City:
International
Topic:
Medical Device Identification
Document Type:
Application Guide
Organization / Institution:
International Medical Device Regulators Forum (IMDRF)
Author:
IMDRF UDI WG
Target Audience:
Medical device regulatory authorities, manufacturers, healthcare stakeholders
Period of validity:
Not specified
Approval Date:
12 July 2018
Date of Changes:
Not specified
Context:
This document provides a detailed guide on implementing a harmonized Unique Device Identification (UDI) system for medical devices to aid regulatory authorities, manufacturers, and stakeholders in the healthcare supply chain.
Year:
2013
Region / city:
Global
Topic:
Medical Devices, UDI System
Document Type:
Guidance
Organization / Institution:
IMDRF
Author:
IMDRF UDI Working Group
Target Audience:
Regulatory authorities, healthcare professionals, manufacturers
Period of validity:
Not specified
Approval date:
9 December 2013
Date of revisions:
Not specified
Year:
2026
Region / Country:
United States
Subject:
Medical and dental device labeling and regulatory compliance
Document Type:
Standard Operating Procedure (SOP)
Organization:
Carestream Health
Author:
Regulatory Affairs Department
Target Audience:
Project teams, business managers, regulatory and purchasing personnel
Effective Period:
Indefinite until updated
Approval Date:
2026-03-12
Revision Date:
Not specified
Scope:
Devices, items, and parts requiring Unique Device Identifier (UDI) under FDA regulations
Procedures Included:
Labeler determination, documentation requirements, contractual responsibilities
Device Types:
Electronic and non-electronic medical devices
Year:
2026
Region / city:
Washington State
Subject:
Solid waste management, organics recycling
Document Type:
Application form
Organization:
Washington State Department of Ecology
Author:
Washington State Department of Ecology
Target Audience:
Jurisdictions implementing solid waste plans
Effective Period:
February 2026 – December 31, 2026
Approval Date:
N/A
Date of Changes:
N/A
Year:
2024
Region / City:
Not specified
Theme:
Family and criminal justice, information disclosure
Document Type:
Protocol
Institution:
NPCC
Author:
Tina Hall
Target Audience:
Police forces, local authorities, judiciary, CPS
Period of Action:
2024 and beyond
Approval Date:
March 2024
Date of Amendments:
Not specified
Agency:
U.S. Environmental Protection Agency
Office:
Office of Wetlands, Oceans and Watersheds
Program:
Clean Water Act Section 401(a)(2)
Document type:
Application template and explanatory guidance
Intended applicants:
Federally recognized Tribes
Legal basis:
33 U.S.C. 1341(a)(2); 40 CFR Part 121
Policy area:
Water quality certification
Geographic scope:
Tribal reservations and neighboring jurisdictions
Eligibility criteria:
Treatment in a similar manner as a state (TAS)
Regulatory status:
Non-regulatory program
Audience:
Tribal governments and administrators
Source authority:
U.S. Department of the Interior; EPA Regional Administrators
Year:
2023
Region / city:
United States
Topic:
Immigration law, legal motions
Document type:
Template motion
Agency / institution:
U.S. Department of Justice, Executive Office of Immigration Review
Author:
Not specified
Target audience:
Legal practitioners, immigration attorneys
Period of validity:
Pending Supreme Court decisions
Approval date:
August 1, 2023
Date of amendments:
Not specified
Year:
2023
Region / City:
Online
Topic:
International Business
Document Type:
Syllabus
Organization:
Bryan School of Business and Economics, University of North Carolina-Greensboro
Author:
Dr. Mark Mallon
Target Audience:
Students enrolled in MGT 302-01
Period of Action:
Fall 2023
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2026
Organization:
MFSMA (Missouri Farm & Small Market Association)
Type of document:
Directory / Contact List
Positions Listed:
President, Vice-President, Executive Director, Treasurer/Secretary, Area Directors, At-Large Directors
Regions Covered:
Missouri counties including Cape Girardeau, Montgomery, Atchison, Nodaway, Holt, Andrew, Worth, Gentry, DeKalb, Buchanan, Platte, Clinton, Clay, Jackson, Cass, Bates, Harrison, Daviess, Caldwell, Ray, Lafayette, Johnson, Henry, St. Clair, Mercer, Grundy, Livingston, Carroll, Saline, Pettis, Benton, Putnam, Sullivan, Linn, Chariton, Howard, Schuyler, Adair, Macon, Randolph, Scotland, Knox, Shelby, Clark, Lewis, Marion, Ralls, Monroe, Pike, Lincoln, St. Louis, Jefferson, Audrain, Callaway, Boone, Cooper, Gasconade, Franklin, Warren, Osage, Cole, Moniteau, Morgan, Miller, Maries, St. Louis City, Vernon, Barton, Jasper, Newton, McDonald, Cedar, Dade, Lawrence, Barry, Hickory, Polk, Greene, Christian, Stone, Camden, Dallas, Laclede, Webster, Wright, Douglas, Ozark, Taney, Pulaski, Phelps, Dent, Texas, Shannon, Howell, Oregon, Ripley, Carter, Crawford, Washington, Iron, Reynolds, Ste. Genevieve, Perry, St. Francois, Madison, Bollinger, Wayne, Scott, Stoddard, Butler, New Madrid, Pemiscot, Dunklin, St. Charles
Contact Email:
[email protected]
Executive Director:
Ellie Marr
President:
Chris Dunnaway
Vice-President:
Mike Beaty
At-Large Director #1:
Vacant
At-Large Director #2:
Larry Lacy
At-Large Director #3:
Shanna Michael
Treasurer/Secretary:
Vacant
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:
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
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