№ files_lp_3_process_9_61825
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Character count: 19031
File size: 75 KB
Official checklist issued by the World Health Organization establishing structured content, formatting, administrative, and regulatory requirements for submission of product dossiers under the prequalification assessment of in vitro diagnostics.
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
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
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
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:
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:
2025
Organization:
World Health Organization
Department:
Regulation and Prequalification, Health Systems Division
Document type:
Expression of Interest Form
Identifier:
WHO/MHP/RPQ/PQT/2025.6
Licence:
CC BY-NC-SA 3.0 IGO
Effective date:
January 2026
Intended audience:
Legal manufacturers of in vitro diagnostic products
Submission method:
Electronic, as searchable PDF
Date:
22 March 2022
Location:
Via Zoom
Subject:
Evaluation of Transperineal biopsy for diagnosing prostate cancer
Type:
Meeting minutes
Institution:
National Institute for Health and Care Excellence (NICE)
Author:
Mark Kroese, Chair
Target audience:
Committee members, external assessment group representatives, public and company representatives
Period:
22 March 2022
Approval date:
22 March 2022
Amendment date:
N/A
Note:
Context
Year:
2015
Document version:
IBSA 1/2015
Document title:
Medical Diagnostics Form (MDF) for Athletes with Visual Impairment
Document type:
Medical diagnostic form
Issuing organization:
International Blind Sports Association
Field:
Sports medicine
Medical specialty:
Ophthalmology
Target group:
Athletes with visual impairment
Purpose:
International classification of athletes
Language requirement:
English
Validity period:
Not older than 12 months at the time of international classification
Submission system:
ISAS (IBSA system)
Submission deadline:
6 weeks prior to first classification day
Certification required by:
Registered ophthalmologist
Applicable classifications:
B1, B2, B3, NE
Related sport context:
Paralympic and IBSA-recognized sports
Format requirement:
PDF
Source type:
Official medical and classification record
Organization:
Unitaid
Document type:
Proposal application form
Call title:
Expanding access to essential diagnostics through integration
Sector:
Global health diagnostics
Target countries:
Low- and middle-income countries
Funding mechanism:
Grant funding
Currency:
United States dollar (USD)
Proposal components:
Executive summary, project design and implementation, budget, governance, risk management, procurement
Version number:
[e.g. 0]
Version date:
[e.g. 01 October 2025]
Strategic alignment:
Unitaid Strategic Framework 2023–27
Thematic focus:
Integrated diagnostic tools and strategies, including point-of-care technologies
Target settings:
National and subnational health systems
Application requirements:
Word limits, specified font, no additional annexes beyond listed
Year:
2023
Region / city:
Global
Subject:
Arms control, international relations
Document type:
Research appendix
Organization / institution:
Not specified
Author:
Not specified
Target audience:
Researchers, policymakers
Effective period:
Not specified
Approval date:
Not specified
Date of revisions:
Not specified
Year:
2023
Region / City:
Sunnybrook Health Sciences Centre
Theme:
Quality Management System
Document Type:
Guideline
Organization / Institution:
Sunnybrook Health Sciences Centre
Author:
Not specified
Target Audience:
Laboratory personnel, healthcare professionals
Period of validity:
Ongoing
Approval Date:
June 2023
Date of changes:
August 2023
Year:
2026
Region / City:
Not specified
Topic:
Research Funding, Academic Support
Document Type:
Application Guidelines
Organization:
Division of Diagnostics Genetics & Genomics (DGG)
Author:
Not specified
Target Audience:
Faculty members in the field of Diagnostic Genetics & Genomics
Period of Activity:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Year:
2023
Region / City:
United Kingdom
Topic:
Molecular Diagnostics, Fetal Blood Group Genotyping
Document Type:
Referral Form
Organ / Institution:
NHS Blood and Transplant
Author:
NHS Blood and Transplant
Target Audience:
Healthcare Providers, Medical Professionals
Effective Period:
Ongoing
Approval Date:
Not specified
Amendment Date:
Not specified
Date:
18 January 2024
Location:
Zoom
Committee Members Present:
Brian Shine (Chair), Neil Hawkins (Vice Chair), Rebecca Allcock, Joy Allen, John Cairns, Sam Creavin, Diane Davies, Farai Goromonzi, Rashmi Kumar, Patrick McGinley, Alex Novak, Radha Ramachandran, Anne Scott, Matt Stevenson, Jonathan Weir-McCall
External Assessment Group Representatives Present:
Mark Simmonds, Matthew Walton
Specialist Committee Members Present:
Roger Aldridge, Stephanie Gallard, Kate Hawley, Eugene Healy, Nalayini Kumaralingam, Rubeta Matin, Stephen McKenna, Susan Mountain
Observers Present:
Matthew Brown, Ruth Melville, Ziqi Zhou, Charlotte Fairclough, Tom Lawrence, Stephen Duffield, Michael Merchant, Anne Murray-Cota, James Le Fevre
Year:
2024
Region / City:
United Kingdom
Topic:
Health technology evaluation
Document Type:
Meeting minutes
Author:
National Institute for Health and Care Excellence (NICE)
Target Audience:
Professionals in healthcare, medical technology evaluation
Period of Action:
January 2024
Approval Date:
18 January 2024
Date of Next Meeting:
12 March 2024
Note:
Contextual Description
Date:
26 April 2022
Location:
Via Zoom
Attendees:
Mark Kroese (Chair), Keith Abrams, Liz Adair, Rebecca Allcock, John Cairns, Sam Creavin, Diane Davies, Neil Hawkins, Brendan Meyer, Patrick McGinley, Radha Ramachandran, Karen Sennett, Brian Shine, Matt Stevenson, Alasdair Taylor, Rebecca Albrow, Thomas Walker, Suvi Harmala, Simon Webster, Toni Gasse, Harriet Wilson, Alex Sexton, Marie Westwood, Nigel Armstrong, Jonathan Shepherd, Ines Souto Ribeiro, Ben Kearns, Margaret Cheng, Tim England, Carole Gavin, Nigel Hoggard, Grant Mair, Kiruba Nagaratnam, Jonathan Shapey, Li Su, David Werring, Joanna Girling, Sarah Findlay, Shonagh Haslam, Jenny Myers, Andrew Sharp, Elaine Sheehan, Nigel Simpson, Manu Vatish, Lyn Davies, Hayley Garnett, Jean Isaac, Laura Marsden, Edgar Masanga, Ian Mather, Clíodhna Ní Ghuidhir, Cheryl Pace
Meeting Type:
Diagnostics Advisory Committee Meeting
Subject:
Evaluation of ‘Software with artificial intelligence derived algorithms for analysing CT brain scans in people with a suspected acute stroke’
Minutes approved:
22 March 2022 meeting
Conflicts of interest:
Keith Abrams, Liz Adair, Rebecca Allcock
Approval of interests:
Keith Abrams, Liz Adair
Specialty:
Health Technology Assessment, Stroke Medicine
Year:
2022
Location:
Via Zoom
Subject:
Health Technology Assessment
Document Type:
Meeting Minutes
Author:
National Institute for Health and Care Excellence (NICE)
Target Audience:
Committee members, health technology assessment professionals, external assessment group representatives
Period of Validity:
N/A
Approval Date:
31 October 2022
Date of Changes:
N/A