№ lp_1_2_46560
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Character count: 3571
File size: 41 KB
A regulatory compliance checklist outlining essential safety, performance, and design principles applicable to in vitro diagnostic medical devices across their lifecycle.
Document type:
Checklist
Subject area:
Medical device regulatory requirements
Device category:
In vitro diagnostic medical devices
Scope:
Design, manufacture, safety, and performance requirements
Regulatory focus:
Essential principles and general safety requirements
Intended use context:
Clinical and laboratory use
Content structure:
General requirements and design and manufacturing requirements
Compliance demonstration:
Methods and supporting controlled documents
Price: 8 / 10 USD
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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
Year:
2025
Region / city:
European Union
Topic:
Health Technology Assessment (HTA)
Document type:
Guideline / Supplementary material
Author:
HTA CG
Target audience:
Health technology assessors, clinical researchers
Period of validity:
Not specified
Approval date:
28 November 2025
Modification date:
Not specified
Year:
2024
Region / city:
Switzerland
Subject:
Clinical performance study for IVD devices
Document type:
Template
Organization:
swissethics
Author:
swissethics
Target audience:
Researchers, Sponsors, Ethics Committees
Period of validity:
Ongoing
Approval date:
27.06.2022
Modification date:
16.09.2024
Date of changes:
24.06.2025
Year:
2022
Region / City:
Not specified
Field:
Endodontics
Document Type:
Research Article
Institution:
Not specified
Author:
Not specified
Target Audience:
Dental researchers, endodontists
Period of Action:
Not specified
Approval Date:
Not specified
Modification Date:
Not specified
Contextual description:
Research article comparing dentinal crack formation using different rotary file systems for root canal preparation.
Year:
2022
Region / City:
Not specified
Topic:
Bone health, flavonoids, sea buckthorn
Document Type:
Research Table
Institution:
Not specified
Author:
Not specified
Target Audience:
Researchers in pharmacology, bone health, and phytochemistry
Period of Action:
Not specified
Approval Date:
Not specified
Date of Changes:
Not specified
Note:
Contextual description
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
Year:
2012
Region / City:
Global
Topic:
Clinical Performance Studies for IVD Medical Devices
Document Type:
Guidance Document
Organization / Institution:
Global Harmonization Task Force (GHTF)
Author:
Kazunari Asanuma, GHTF Chair
Target Audience:
Manufacturers of IVD medical devices, Regulatory Authorities, Conformity Assessment Bodies
Period of Validity:
Ongoing (may apply to both pre-market and post-market studies)
Approval Date:
November 2nd, 2012
Date of Revisions:
Not specified
Year:
2024
Region / City:
European Union
Topic:
In vitro diagnostic medical devices, transitional provisions
Document Type:
Declaration
Organization / Institution:
Manufacturer
Author:
Manufacturer
Target Audience:
Regulatory authorities, notified bodies, manufacturers
Validity Period:
Transition period for medical devices
Approval Date:
N/A
Amendment Date:
N/A
Context Description:
Declaration regarding the transitional provisions for in vitro diagnostic devices under Regulation (EU) 2024/1860, outlining the conditions for continued market placement and conformity assessment procedures.
Year:
Not specified
Region / city:
Not specified
Subject:
Serum protein binding, small proteins
Document type:
Protocol
Organization / institution:
Not specified
Author:
Not specified
Target audience:
Researchers, scientists
Effective period:
Not specified
Approval date:
Not specified
Modification date:
Not specified
Year:
2024
Region / city:
Not specified
Topic:
Anticancer research, Nanotechnology
Document type:
Research paper
Organization / institution:
Not specified
Author:
Not specified
Target audience:
Researchers, biochemists, pharmacologists
Period of validity:
Not specified
Approval date:
Not specified
Date of changes:
Not specified
Year:
2021
Region / City:
Slough, UK
Topic:
Immunology, Dermatology
Document Type:
Research Article
Organization / Institution:
UCB
Author:
Joseph Rastrick, Hannah Edwards, Alex S. Ferecskó, Gaëlle Le Friec, Avneet Manghera, Matthew Page, Stevan Shaw
Target Audience:
Researchers, Healthcare Professionals
Period of Validity:
Not specified
Date of Approval:
Not specified
Date of Changes:
Not specified
Context:
The document is a research article presenting findings on the roles of IL-17A and IL-17F in hidradenitis suppurativa (HS), based on human in vitro and clinical experiments.
Year:
2018
Region / City:
San Joaquin Valley, California
Topic:
Healthcare, Agricultural Industry
Document Type:
Report
Organization:
Diringer and Associates, California Rural Legal Assistance Foundation
Author:
Joel Diringer, JD, MPH, Noe Paramo, JD
Target Audience:
Agricultural workers, policymakers, public health professionals
Period of Action:
April 2018
Date of Approval:
April 2018
Date of Changes:
N/A
Contextual Description:
A report examining the impact of Medi-Cal expansion on farmworkers in San Joaquin Valley, addressing both health coverage and economic consequences for agricultural employers.
Institution:
Wayne State University
Program:
Physical Therapy Program
Document type:
Program policy and standards
Subject area:
Physical therapy education
Purpose:
Admission, retention, and graduation requirements
Applicable settings:
Classroom, laboratory, tutorial, and clinical settings
Regulatory and professional references:
American Physical Therapy Association; Commission on Accreditation for Physical Therapy Education
Intended audience:
Physical therapy students and applicants
Professional scope:
Entry-level generalist physical therapy practice
Ethical framework:
Ethical and safe clinical practice standards
Standards categories:
Academic, clinical, physical, and interpersonal abilities
Academic source type:
Institutional academic policy defining professional competency standards
Year:
2026
Region / City:
Brent, London
Type of Document:
Application form
Issuing Authority:
Brent Council
Target Audience:
Charitable organisations and public sector workers providing essential services
Eligibility:
Statutory service workers, NHS employees, home-visiting staff of religious or non-profit organisations
Vehicle Requirements:
Maximum length 6.5m, maximum height 2.5m, maximum weight 5 tonnes
Usage Restrictions:
Only during official duties, not within 750 metres of workplace, not in restricted bays
Application Requirements:
Completed form with applicant and employer declarations
Data Protection:
Personal and vehicle data collected under Data Protection Act for traffic administration and fraud prevention
Year:
2020
Month:
June
Jurisdiction:
United States
Agency:
California Department of Transportation
Division:
Division of Environmental Analysis, Office of Biology
Subject:
Biological assessment
Note:
Subject
Essential fish habitat
Legal framework:
Federal Endangered Species Act
Consultation authorities:
National Marine Fisheries Service
Regulatory references:
50 CFR Ch. IV Sections 402.12 and 402.14(c)
Regulatory updates referenced:
FESA regulations published in 2019
Critical habitat terminology:
Physical or Biological Features
Intended use:
FESA Section 7 consultations
Geographic scope:
State Highway System projects
Document type:
Standardized assessment template
Revision:
Third revision
Accessibility standard:
Americans with Disabilities Act
Source type:
Government technical guidance
Note:
Year
Organization / Institution:
NHS Blood and Transplant
Target Audience:
Healthcare professionals, medical researchers
Contextual Description:
This is a referral form for blood and tissue sample testing, including various genotyping services, used by NHS Blood and Transplant.