№ lp_2_3_39197
File format: docx
Character count: 14674
File size: 84 KB
This document provides guidelines for using the IMDRF Table of Content format in the pre-Regulated Product Submission (RPS) phase, focusing on its application for medical device submissions.
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
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
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:
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:
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
Year:
2002
Region / City:
Manchester
Topic:
Safety, Hazard Assessment, Chemical Risk
Document Type:
Risk Assessment Guidelines
Organization / Institution:
University of Manchester
Author:
Not specified
Target Audience:
Safety Officers, Laboratory Managers, Researchers
Period of Validity:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Year:
2025
Region / City:
Pinal County, Arizona
Subject:
Public hearing, variance application
Document type:
Public notice
Organ / institution:
Pinal County Development Services Department
Author:
Pinal County Development Services Department
Target audience:
Residents of Pinal County
Period of validity:
Not specified
Approval date:
December 29, 2025
Amendment date:
Not specified
Context:
Public notice related to a variance application for a land use case in unincorporated Pinal County, Arizona, for the purpose of reducing the minimum required lot area.
Year:
2021
Region / City:
Philippines
Topic:
Recovery Plans
Document Type:
Guidance Paper
Organization / Institution:
Bangko Sentral ng Pilipinas (BSP)
Author:
World Bank
Target Audience:
BSP Bank Supervisors
Period of Application:
April 2021
Approval Date:
8 April 2021
Date of Changes:
-
Year:
2025
Region / City:
Oskaloosa, Iowa
Theme:
Public Works, City Planning
Document Type:
Agenda Memo
Institution:
City Council
Author:
Sean Murphy
Target Audience:
City Council Members, Public Works Department
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A
Prepared by:
Office of Non-clinical and Clinical Compliance, Pharmaceutical and Medical Devices Agency
Organization:
Pharmaceutical and Medical Devices Agency
Country:
Japan
Date of preparation:
January 26, 2017
Version:
1.0
Subject area:
Medical devices regulation
Topic:
Non-clinical studies
Document type:
Regulatory guidance
Inspection type:
Document-based conformity inspection
Legal basis:
Law on Securing Quality, Efficacy and Safety of Products Including Pharmaceuticals and Medical Devices
Target materials:
Supporting data and documents for approval applications
Scope:
Non-clinical studies of medical devices
Intended users:
Applicants for medical device approval and inspection personnel
Year:
2024
Region / city:
Monaco
Topic:
Environmental protection, radioactive substances, marine environment
Document type:
Terms of Reference
Organ / institution:
OSPAR Radioactive Substances Committee (RSC)
Author:
OSPAR
Target audience:
Contracting Parties, Observers, Environmental professionals
Period of validity:
2024–2026
Approval date:
February 2024
Modification date:
Not specified
Note:
Year
Topic:
Health and Safety, Construction Design and Management
Document Type:
Guidance
Target Audience:
Land managers, Designers, Contractors
Year:
2017
Region / City:
California
Subject:
Energy, Distributed Energy Resources, Rulemaking
Document Type:
Rulemaking Order
Issuing Authority:
Public Utilities Commission of the State of California
Target Audience:
Utility companies, regulatory bodies, stakeholders in the energy sector
Period of Effect:
Ongoing
Approval Date:
July 13, 2017
Amendment Date:
None
Year:
2015
Region / city:
Global
Subject:
MedDRA Term Selection Changes
Document Type:
Guide
Organization / Institution:
ICH
Author:
ICH MedDRA Working Group
Target Audience:
MedDRA Users
Period of validity:
Not specified
Approval date:
1 March 2015
Date of changes:
March 2015
Year:
2026
Region / City:
California
Subject:
California Renewables Portfolio Standard Program
Document Type:
Decision
Agency / Institution:
Public Utilities Commission of the State of California
Author:
Alice Reynolds, Darcie L. Houck, John Reynolds, Karen Douglas, Matthew Baker
Target Audience:
Public, Stakeholders in Renewable Energy
Effective Date:
January 15, 2026
Expiration Date:
January 25, 2028
Date of Issuance:
January 16, 2026
Decision Number:
26-01-014
Deadline Extension:
January 25, 2028
Year:
2015
Theme:
Masonic fraternity and leadership
Document Type:
Speech
Organization:
Masonic Lodge
Author:
Not specified
Target Audience:
Masonic brethren
Period of Validity:
N/A
Approval Date:
N/A
Date of Changes:
N/A