№ lp_1_29601
File format: docx
Character count: 7468
File size: 42 KB
Harmonized regulatory guidance defining the terms “medical device” and “in vitro diagnostic medical device” within an international regulatory framework for medical devices.
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
Price: 8 / 10 USD
The file will be delivered to the email address provided at checkout within 12 hours.
The file will be delivered to the email address provided at checkout within 12 hours.
Don’t have cryptocurrency yet?
You can still complete your purchase in a few minutes:- Buy Crypto in a trusted app (Coinbase, Kraken, Cash App or any similar service).
- In the app, tap Send.
- Select network, paste our wallet address.
- Send the exact amount shown above.
The final amount may vary slightly depending on the payment method.
The file will be sent to the email address provided at checkout within 24 hours.
The product description is provided for reference. Actual content and formatting may differ slightly.
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:
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
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:
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
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
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
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