№ lp_1_2_49270
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The document is a registration form for medical devices and in vitro diagnostic devices (IVDDs) intended for submission to the Rwanda FDA.
Year:
2022
Region / City:
Rwanda
Theme:
Medical Devices Registration
Document Type:
Form
Organization:
Rwanda FDA
Author:
Rwanda FDA
Target Audience:
Applicants for medical device registration
Period of Validity:
From 31 October 2022 to 30 October 2025
Approval Date:
31/10/2022
Date of Revision:
17/10/2022
Review Due Date:
30/10/2025
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The product description is provided for reference. Actual content and formatting may differ slightly.
Year:
2022
Note:
Region / city
Topic:
Medical Devices, Safety, Compliance
Document Type:
Checklist
Organization / institution:
DFAR Department
Target Audience:
Manufacturers, Regulatory Bodies, Medical Device Industry
Effective Date:
31/10/2022
Review Due Date:
30/10/2025
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
Organization:
National Institute for Health and Care Excellence
Centre:
Centre for Health Technology Evaluation
Committee:
Diagnostics Advisory Committee
Document type:
Meeting minutes
Meeting date:
28 September 2022
Location:
Via Zoom
Session type:
Open session
Chair:
Brian Shine
Topic:
Evaluation of MRI-based technologies for assessing non-alcoholic fatty liver disease
Participants:
Committee members, NICE staff, external assessment groups, external assessment centres, specialist committee members, experts, observers
Conflicts of interest:
Declarations recorded
Approval status:
Minutes confirmed
Year:
2023
Region / City:
USA
Topic:
Medical billing, self-pay pricing
Document Type:
Pricing guide
Organization / Institution:
American Medical Association
Author:
American Medical Association
Target Audience:
Healthcare providers, medical practitioners
Period of Validity:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Year:
2021
Region / city:
Norfolk, Virginia, Hampton, Virginia
Topic:
Hypersonic flow generation, diagnostics, CFD validation, thermal loading
Document Type:
Research paper
Organization / institution:
Norfolk State University, NASA Langley Research Center
Author:
Kyo D. Song, Sang H. Choi
Target audience:
Researchers, engineers, aerospace scientists
Period of validity:
N/A
Approval date:
N/A
Date of modifications:
N/A
Note:
Year
The document is a Quality Manual outlining the quality management system, policies, and procedures of the Genomic Diagnostics Laboratory, ensuring compliance with ISO 15189:
2012 standards.
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
Year:
2017
Region / city:
EU
Topic:
In vitro diagnostic medical devices, Performance studies
Document type:
Checklist
Organization:
European Union
Author:
Unknown
Target audience:
Manufacturers of in vitro diagnostic medical devices, clinical investigators, regulatory bodies
Effective period:
Ongoing
Approval date:
Unknown
Date of changes:
Unknown
Document code:
GHTF/SG1/N071:2012
Revision of:
GHTF/SG1/N29:2005
Year:
2012
Date:
May 16, 2012
Organization:
Global Harmonization Task Force
Authoring group:
Study Group 1 of the Global Harmonization Task Force
Document type:
Guidance document
Subject area:
Medical device regulation
Geographical scope:
International
Regulatory status:
Non-binding guidance
Intended audience:
Regulatory authorities, conformity assessment bodies, regulated industry
Supersedes:
Definition of the Term “Medical Device”, 2005
Copyright holder:
Global Harmonization Task Force
Year:
2021
Region / city:
International
Subject:
In Vitro Diagnostic (IVD) Medical Devices Classification
Document type:
Guidance document
Author:
IMDRF IVD Working Group
Target audience:
Regulatory Authorities, Conformity Assessment Bodies, Industry
Period of validity:
Not specified
Approval date:
21 January 2021
Amendment date:
Not specified
Copyright holder:
International Medical Device Regulators Forum
Copyright year:
2021