№ lp_2_3_39198
File format: docx
Character count: 18541
File size: 73 KB
The document outlines the implementation plan for a pilot program to test a Table of Contents (ToC) structure for regulatory submissions across multiple jurisdictions.
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
Price: 8 / 10 USD
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The product description is provided for reference. Actual content and formatting may differ slightly.
Note:
Year
Year:
2025
Region / City:
Chicago, IL
Theme:
Healthcare, Medical Equipment
Document Type:
Resource Guide
Institution:
CountyCare
Author:
N/A
Target Audience:
Healthcare Providers, CountyCare Teams
Effective Period:
May 2025
Approval Date:
N/A
Revision Date:
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
Document Type:
Technical Specification
Product Name:
Hach BioTector B3500ul Online TOC Analyzer
Manufacturer:
Hach Ireland Ltd
Measurement Parameters:
Total Organic Carbon (TOC), Total Carbon (TC), Total Inorganic Carbon (TIC), Biological Oxygen Demand (via correlation), Chemical Oxygen Demand (via correlation), Volatile Organic Carbon (via calculation)
Measurement Method:
Two Stage Advanced Oxidation utilizing hydroxyl radicals and manganese catalyst
Measurement Range:
0 – 5 mgC/l
Detection Limit:
0.010 mgC/l
Repeatability:
±2% of reading or ±0.01 mgC/l
Cycle Time:
From 5 minutes depending on range and application
Sample Requirements:
Minimum 100 ml per analysis; ambient pressure; 2 to 60 °C
Operating Conditions:
0 to 45 °C; 5 to 85% relative humidity non-condensing
Certifications:
CE, KC, ACMA, China RoHS
Warranty Period:
One year from date of shipment
Installation Requirements:
Installation per transmittal drawings and user manual; manufacturer start-up and service required
Service Conditions:
Factory-trained personnel only; manufacturer parts and reagents required
Data Transmission:
SD card
Year:
2022
Version:
4
Place of publication:
Geneva
Organization:
World Health Organization
Department:
WHO Prequalification of In Vitro Diagnostics
Document code:
WHO/MHP/RPQ/PQT/2022.03
Licence:
Creative Commons Attribution-NonCommercial-ShareAlike 3.0 IGO (CC BY-NC-SA 3.0 IGO)
Subject:
Prequalification of in vitro diagnostics
Document type:
Product dossier checklist
Intended users:
IVD manufacturers submitting dossiers for WHO prequalification
Related document:
IMDRF/RPS WG/N13 FINAL:2019 (Edition 3)
Language requirement:
English
Format requirement:
Searchable PDF
Administrative reference:
PQDx_015 Pre-Submission Form
International guideline referenced:
International Medical Device Regulators Forum
Year:
2012
Region / city:
United States
Topic:
Speech Codes on University Campuses
Document Type:
Article
Author:
Greg Lukianoff
Target Audience:
Students, Educators, Policy Makers
Period of Action:
Ongoing
Approval Date:
December 19, 2012
Date of Changes:
None
Note:
Contextual Description
Year:
[Year]
Region / City:
[NAME OF JURISDICTION]
Topic:
Transit-Oriented Communities Compliance
Document Type:
Resolution
Institution:
Metropolitan Transportation Commission (MTC)
Author:
[MAYOR OR CITY MANAGER]
Target Audience:
Metropolitan Transportation Commission (MTC), Local Jurisdictions
Action Period:
2026
Approval Date:
[Approval Date]
Amendment Date:
[Amendment Date]
Year:
2016
Region / City:
Brazil
Topic:
Soil analysis
Document Type:
Research report
Institution:
Gomes
Author:
Gomes
Target audience:
Researchers, Soil Scientists
Effective Period:
N/A
Approval Date:
N/A
Amendment Date:
N/A
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:
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
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:
2026
Region / City:
Zambia
Topic:
Insurance, Procurement, Health Organization
Document Type:
Request for Proposal (RFP)
Organization / Institution:
Amref Health Africa
Author:
Amref Health Africa
Target Audience:
Insurance companies, brokers
Period of Validity:
1 January 2026 to 31 December 2026
Approval Date:
Not specified
Date of Changes:
Not specified
Context:
A formal request for proposals for insurance and equipment coverage for Amref Health Africa’s Zambia operations, detailing technical specifications and requirements for various insurance services.
Year:
2023
Region / city:
Singapore
Topic:
Pharmaceutical manufacturing and regulatory requirements
Document type:
Regulatory guideline
Organization:
Health Sciences Authority
Author:
Health Sciences Authority
Target audience:
Pharmaceutical manufacturers, regulatory professionals
Validity period:
N/A
Approval date:
N/A
Amendment date:
N/A