№ lp_1_2_53958
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This document outlines the essential principles for the design and manufacturing of medical and IVD medical devices to ensure their safety and performance, aiming for global regulatory convergence.
Year:
2018
Region / City:
International
Topic:
Medical devices, IVD medical devices, safety, performance
Document Type:
Guideline
Organization / Institution:
International Medical Device Regulators Forum
Author:
IMDRF Good Regulatory Review Practices Group
Target Audience:
Regulatory Authorities, Conformity Assessment Bodies, manufacturers, industry stakeholders
Effective Period:
Not specified
Approval Date:
31 October 2018
Amendment Date:
Not specified
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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
Note:
Year
Topic:
Clinical trials, IVD device validation
Document type:
Clinical trial documentation
Target audience:
Regulatory bodies, clinical trial staff, manufacturers
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:
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
Organization:
International Medical Device Regulators Forum
Authoring Group:
IMDRF Good Regulatory Review Practices
Document type:
Guidance document
Status:
Proposed document
Identifier:
IMDRF GRRP WG (PD1)/N52
Date:
12 July 2018
Scope:
General content and format of labeling for medical devices and IVD medical devices
Applies to:
Medical devices and in vitro diagnostic medical devices
Intended audience:
Regulatory Authorities, Conformity Assessment Bodies, industry, users and relevant third parties
Supersedes:
GHTF/SG1/N70:2011 “Label and Instructions for Use”
Related principles:
IMDRF Essential Principles of Safety and Performance
Source type:
International regulatory guidance
Year:
2021
Region / City:
USA
Theme:
Medical diagnostics
Document type:
Technical datasheet
Organization:
ZEUS Scientific
Author:
ZEUS Scientific
Target audience:
Healthcare professionals, laboratory technicians
Period of validity:
Not specified
Approval date:
Not specified
Date of modifications:
Not specified
Context description:
A technical datasheet describing the components, precautions, and procedural instructions for the ZEUS IFA EBV-VCA IgM Test System for detecting EBV-VCA IgM antibodies in human sera.
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.
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:
2022
Region / city:
Sri Lanka
Topic:
Pharmaceuticals import
Document type:
Invitation for expressions of interest
Organization:
Ministry of Health, Sri Lanka
Author:
Ministry of Health
Target audience:
Pharmaceutical suppliers
Period of validity:
3 months
Approval date:
27th September 2022
Date of amendments:
N/A
Note:
Year
Topic:
Educational Support Strategies
Document Type:
Instructional Support Guidelines
Year:
2026
Region / city:
Sacramento
Subject:
Executive Office Analyst Position Responsibilities
Document Type:
Duties Statement
Agency / Institution:
California Department of Forestry and Fire Protection (CAL FIRE)
Author:
California Department of Forestry and Fire Protection
Target audience:
CAL FIRE employees
Effective period:
From 1/1/2026
Approval Date:
1/1/2026
Date of Changes:
N/A
Note:
Year
Field:
Community Development
Document Type:
Guidelines
Organization / Institution:
Community Development Journal
Target Audience:
Researchers, Practitioners, Academics in Community Development
Contextual Description:
A set of guidelines outlining the expectations and submission process for prospective authors submitting peer-reviewed articles to the Community Development Journal.
Date:
May 29, 2012
Jurisdiction:
Arkansas, United States
Policy area:
Health insurance regulation
Topic:
Essential health benefits
Legal framework:
Affordable Care Act
Document type:
Policy report
Issuing context:
Federally Facilitated Health Benefits Exchange
Advisory bodies referenced:
Arkansas Plan Management Advisory Committee; Health Benefit Exchange Steering Committee
Federal agencies referenced:
U.S. Department of Health and Human Services; U.S. Department of Labor
Benchmark scope:
Individual and small group insurance markets
Mandated benefits discussed:
Arkansas state-mandated health insurance benefits
Timeframe of analysis:
2011–2014
Year:
2024
Region / city:
Sierra Leone
Theme:
Health Services, Project Evaluation
Document Type:
Aide Memoire
Organization / Institution:
World Bank
Author:
World Bank Mission Team
Target Audience:
Government of Sierra Leone, Ministry of Health, Health Development Partners
Period of Validity:
October 21 – November 15, 2024
Approval Date:
November 15, 2024
Date of Modifications:
None
Note:
Year