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International regulatory guidance establishing globally harmonized principles for the content and presentation of labels, instructions for use, and patient information associated with medical devices and in vitro diagnostic medical devices.
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
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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:
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
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.
Document type:
Standard Operating Procedure
Subject:
Sharps safety, waste management, and labeling
Scope:
Laboratories and research facilities
Hazard categories:
Biohazardous waste, medical waste, chemical waste, radioactive waste, non-contaminated sharps
Waste handling methods:
Autoclaving, certified waste pickup, landfill disposal
Responsible units:
Environmental Health & Safety (EH&S), Autoclave Core
Geographic context:
Santa Barbara, California
Associated facilities:
UCSB laboratories and waste management services
Health and safety procedures:
Personnel exposure response and medical treatment
Intended audience:
Laboratory personnel, staff, and students
Regulatory context:
Medical, chemical, and radioactive waste handling requirements
Note:
Year
Topic:
Health, Pharmaceuticals
Document Type:
Informational Resource
Organization / Institution:
U.S. Food and Drug Administration
Target Audience:
Consumers, Healthcare Providers, Information Professionals, Researchers
Year:
2025
Region / city:
USA
Topic:
Pesticide Labeling, Bilingual Requirements
Document Type:
Government Report
Agency / Organization:
Environmental Protection Agency (EPA)
Author:
Environmental Protection Agency (EPA)
Target Audience:
Stakeholders in the pesticide industry, regulatory bodies
Period of Effect:
Ongoing, with a specific deadline on December 29, 2025
Approval Date:
Not specified
Date of Changes:
Not specified
Catalog#:
1244-302
Intended use:
Research use only
Kit contents:
Labelling reagent (Eu-N1 ITC chelate), Eu-Standard, Enhancement Solution, Stabilizer (BSA), uncoated microtitration plate, DELFIA Assay Buffer, Wash Concentrate
Required but not supplied:
Labelling buffer, chromatographic system, elution buffer, column decontamination buffer, precision pipettes, spectrophotometer, automatic shaker, VICTOR™ Multilabel Counter
Warnings:
Contains sodium azide, handle Eu3+ solutions carefully, dispose of waste according to local regulations
Labeling conditions:
Protein in amine-free buffer, 50–100 mM sodium bicarbonate/carbonate buffer, pH 9–9.3, +4°C, overnight reaction
Expected labeling yield:
1–12 Eu3+ per IgG depending on molecular weight and type (monoclonal/polyclonal)
Storage:
Thermodynamically stable for long-term storage of labeled proteins
Author/Manufacturer:
PerkinElmer
Document type:
Administrative request form
Program:
Climate Action Reserve
Labeling standard:
Core Carbon Principles (CCP)
Applicable protocol:
Mexico Forest Protocol
Protocol version:
Mexico Forest Protocol V
Geographic scope:
Mexico
Eligible project activity:
Improved Forest Management
Permanence requirement:
Minimum 40-year commitment
Registry role:
Registry account holder submission
Governing body references:
ICVCM
Submission format:
Microsoft Word document
Submission channel:
Email submission to the registry
Intended submitter:
Project registry account holder
Reporting scope:
Issued offset credits by vintage and reporting period
Credit type:
Forest carbon offset credits
Source classification:
Program administration and credit labeling records
Year:
2025
Region / city:
Massachusetts, Boston
Topic:
Health care, reproductive and gender-affirming medications
Document type:
Advisory
Organization / institution:
Massachusetts Department of Public Health
Author:
Massachusetts Department of Public Health
Target audience:
Pharmacies, practitioners prescribing reproductive and gender-affirming medications
Effective period:
Starting from August 7, 2025
Date of approval:
December 18, 2025
Statutory authority:
M.G.L. c. 94C §§ 21 and 22
Year:
2024
Region / City:
MA, NE, CA
Theme:
Durable Labeling Products
Document Type:
Product Catalog
Organization:
Flexcon
Target Audience:
Manufacturers, Distributors, Packaging Professionals
Effective Period:
2024
Approval Date:
4/22/2024
Year:
2020
Region / city:
Taipei, Taiwan
Subject:
Food safety, food regulation
Document type:
Draft regulation
Agency / institution:
Food and Drug Administration, Ministry of Health and Welfare, Taiwan
Author:
Food and Drug Administration, Ministry of Health and Welfare
Target audience:
Regulatory bodies, food industry
Period of validity:
To be determined
Approval date:
To be determined
Amendment date:
N/A
Year:
2023
Region / City:
N/A
Subject:
Packaging and Labeling Standards
Document Type:
Glossary
Organization:
NIST
Author:
NIST
Target Audience:
Manufacturers, Regulatory Authorities, and Quality Inspectors
Period of Validity:
Ongoing
Approval Date:
N/A
Modification Date:
N/A
Business Name:
Not specified
Cert No:
Not specified
Section:
Product Development
Regulatory References:
205.301; 205.303; 205.307
Program:
WSDA Organic Program
Related Forms:
Handled Product Application (AGR 2524); Processed Product Application (AGR 2523)
Subject:
Addition of new organic products prior to marketing, labeling, or distribution
Note:
Subject
Organic labeling activities and approval procedures
Document Type:
Certification compliance questionnaire
Industry Sector:
Organic food production and handling
Geographic Scope:
Washington State
Certifying Authority:
Washington State Department of Agriculture (WSDA)
Website Reference:
https://agr.wa.gov/departments/organic/forms-and-applications
Jurisdiction:
Not specified
Legal Basis:
Subparagraph 10 of Paragraph 1 of Article 22 of the Act Governing Food Safety and Sanitation
Subject Matter:
Food labeling and product naming standards
Products Covered:
Prepackaged butter, cream, margarine, fat spreads
Type of Document:
Administrative regulation
Scope:
Product definitions and labeling requirements
Definitions Included:
Butter, cream, margarine, fat spreads
Prohibited Labeling Terms:
Vegetable butter
Minimum Milkfat Content (Butter):
At least 80%
Milkfat Range (Cream):
At least 10% but less than 80%
Fat Content Requirement (Margarine):
At least 80%
Fat Content Range (Fat Spreads):
At least 10% but less than 80%
Year:
2022
Region / city:
Oakland, CA
Topic:
Food labeling, Nutrient content claims
Document type:
Comments on proposed rule
Organization / institution:
Yumbini Foods, LLC
Author:
Certified Foods Scientist
Target audience:
Food regulatory authorities, food industry professionals
Period of validity:
N/A
Approval date:
N/A
Date of amendments:
N/A