GHTF ( Global Harmonization

Task Force) STUDY GROUP 4

DOCUMENTATION & REGULATORY WRITING

PRESENTED BY SUBMITTED TO
YUKENDHIRAN C.V (P1824009) Dr. SABA MAANVIZHI
M. PHARM (REGULATORY AFFAIRS) 1ST DEPT. OF PHARMACEUTICS
YEAR SRFOP, SRIHER
DATE: 06/12/2024
DAY: FRIDAY
CONTENTS

• INTRODUCTION
• TRANSITION TO IMDRF:
• IVD MEDICAL DEVICE:
• CLASSIFICATION OF MEDICAL DEVICES
• OPERATING STRUCTURE
• GHTF STUDY GROUP
• STUDY GROUP 4 DOCUMENTS:
• GENERAL PRINCIPLES
• TRAINING REQUIREMENTS FOR AUDITORS
• OVERVIEW OF TYPICAL AUDIT PROCESS
• AUDITING SUBSYSTEMS
2
INTRODUCTION
1
The Global Harmonization Task Force (GHTF) was an international
initiative founded in 1992 to promote uniformity in medical device
regulations worldwide.

2
It emerged from the collective recognition by governments and the
medical device industry that divergent regulatory requirements were
creating barriers to innovation, trade, and patient access to safe and
effective medical devices

3
FOUNDING MEMBERS:

EUROPEAN
UNION

UNITED
STATES

JAPAN

CANADA
4
AUSTRALIA
TRANSITION TO IMDRF:
1 In 2011, GHTF was dissolved, and its 2 IMDRF expanded the scope of GHTF,
work transitioned to the International
incorporating more countries (e.g.,
Medical Device Regulators Forum
Brazil, China, Russia) and addressing
(IMDRF).
modern challenges like software as a
medical device (SaMD), AI, and
cybersecurity in medical devices.

5
KEY MILESTONES:
1 • Formation of GHTF to address global differences in medical device regulations and
9 create common guidelines.
9
2
1 • Development of the GHTF structure, divided into five Study Groups focused on
9 regulatory requirements, quality systems, vigilance, clinical safety, and standards.
9
4
1 • Published foundational guidance documents, including the definition of medical
9 devices, risk classification, and post-market surveillance.
9
9
2 • Worked toward wider global adoption of harmonized standards and built regulatory
0 frameworks for emerging markets.
0
6
2 • GHTF was dissolved, and its mission continued through the International Medical
Device Regulators Forum (IMDRF), with a focus on deeper regulatory
0 convergence and global collaboration.
1
1 6
IVD MEDICAL DEVICE:

1 A device, whether used alone or in combination, intended by the manufacturer

for the in-vitro examination of specimens derived from the human body solely
or principally to provide information for diagnostic, monitoring or
compatibility purposes.
2
This includes reagents, calibrators, control materials, specimen receptacles,
software, and related instruments or apparatus or other articles.

Note:In some jurisdictions, some

IVD medical devices may be
covered by separate regulations.

7
FACTORS INFLUENCING IVD MEDICAL DEVICE CLASSIFICATION

1) The duration of contact of the device with the body

2) The site of the body
3) Whether the device deliver medicine or energy to the patient
4) Intended actions on the human body
5) Whether the device comes in contact with injured skin
6) Whether for diagnosis or treatment
7) The ability to reuse or not
8) Combinations of device

8
CLASSIFICATION OF MEDICAL DEVICES

9
OPERATING STRUCTURE
STEERING COMMITTEE:

 The purpose of the Steering Committee is to provide policy

and direction for the GHTF. It is responsible for the assignment
and oversight of new work items, adopt and monitor GHTF
guidance documents and the authorization and promotion of
GHTF training events.
 The Steering Committee members consist of up to 8 members
from each of the Founding Members' regions. Of the 8
members, up to 4 may be from the regulatory sectors and up
to 4 from the industry sectors.

10
ROLE OF STEERING COMMITTEE:

 Provide Strategic Planning,

 Allocate GHTF Resources As Required
 Assign And Provide Oversight Of New Work Items,
 Actively Monitor Progress Of Assigned Work Items,
 Adopt GHTF Guidance Documents, And Monitor Their Implementation
 Authorize And Promote Training Events As Required

11
GHTF STUDY GROUP

 GHTF Study Groups were specialized working groups established

by the Global Harmonization Task Force (GHTF) to develop
harmonized guidance documents in key areas of medical device
regulation.

 Each Study Group focused on a specific aspect, such as regulatory

frameworks, post-market surveillance, quality systems, auditing,
or clinical evidence, to support global regulatory alignment and
improve safety, efficacy, and trade in medical devices.

12
STUDY GROUPS

Study Group 1 (SG1): • Developed guidance on medical device definitions,

Regulatory Framework classification, conformity assessment, and labeling.

Study Group 2 (SG2): • Focused on adverse event reporting, vigilance

Post-Market systems, and post-market safety monitoring.
Surveillance/Vigilance

Study Group 3 (SG3): • Addressed requirements for quality systems, such

Quality Management Systems as ISO 13485, and their implementation.

• Developed guidance on auditing practices for

Study Group 4 (SG4): regulatory compliance, including quality system
Auditing
inspections.

• Focused on clinical evidence requirements,

Study Group 5 (SG5): including clinical investigations and evaluation
Clinical Safety/Performance
processes.
13
STUDY GROUPS

Conception and development

Manufacture
Packaging and
Labelling
Group 3 & 4
(Quality
Advertising
System/Audi
t) Sale
Group 1
Group 2 (Technical
Use
(Postmarke dossier)
t
Disposal
Surveillanc
e)
14
STUDY GROUP 4 - AUDITING
STUDY GROUP 4 is concerned with examining current quality systems auditing
practices and the harmonization of the auditing process.
ROLE OF GHTF STUDY GROUP 4:

 Has been charged with the task of examining quality management system auditing practices
and developing guidance documents providing harmonized principles for the medical
device auditing process.
 Provide guidance for parties responsible for establishing, planning, carrying out and
documenting audits of quality management systems to address regulatory requirements for
manufacturers of medical devices.
 Outline competence criteria for the auditing team.
 Eliminate duplication of effort and inconsistencies in auditing practices Study Group 4
Began work on the series of documents in 1994-1996. 15
GHTF STUDY GROUP 4 (SG4) ADTOPED COUNTRIES

GHTF Study Group 4 (SG4) documents on auditing practices have been widely adopted or
referenced by many countries, particularly those aligning with international medical device
standards. Key countries and regions include:
Founding Members: Other Adopters:
•United States •China
•European Union •South Korea
•Japan •Brazil
•Canada •Russia
•Australia •Taiwan
•Singapore
•India
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STUDY GROUP 4 DOCUMENTS:
INTRODUCTION:
This document provides guidance for regulators and auditing organizations on auditing
medical device manufacturers' quality management systems using a process-based approach
(e.g., ISO 13485:2003, 21 CFR Part 820). It supports global harmonization of regulatory
systems and ensures safe, effective devices through independent, objective compliance
evaluations. Audits may serve as part of the broader conformity assessment required by
regulations.
Potential benefits for the patients/users, regulators, auditing organizations or auditees include:
• A high degree of assurance (along with technical evaluation, where required in addition) that
safe and effective devices will be available
• Independent, reliable, objective evaluation of compliance with regulatory requirements of
the manufacturer's quality management system 17
ARCHIVED DOCUMENT

GHTF code: GHTF/SG4/N30:2010 - Date posted: 27 August 2010

GHTF SG4 - Guidelines for Regulatory Auditing Part2
•DOC (253 KB)
•PDF (198.44 KB)
GHTF code: GHTF/SG4/N83:2010 - Date posted: 27 August 2010

GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of

Medical Device Manufacturers - Part 4 Multiple Site Auditing - August 2010
•PDF (161.8 KB)
•DOC (159.5 KB)

GHTF code: GHTF/SG4/N84:2010 - Date posted: 27 August 2010

GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of
Medical Device Manufacturers. Part 5 Audits of Manufacturer Control of Suppliers -
August 2012
•PDF (101.61 KB)
•DOC (100.5 KB) 18
ARCHIVED DOCUMENT

GHTF code: GHTF/SG4/N28R4:2008 - Date posted: 27 August 2008

GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of
Medical Device Manufacturers - Part 1: General Requirements
•DOC (192.5 KB)
•PDF (161.38 KB)

GHTF code: GHTF-SG4-N33 R16 - Date posted: 2 October 2007

GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of
Medical Device Manufacturers - Part 3 Regulatory Audit Reports- October 2007
•DOC (78.5 KB)
•PDF (129.18 KB)

GHTF code: GHTF/SG4/N30R20:2006 - Date posted: 28 June 2006

GHTF SG4 - Guidelines for Regulatory Auditing of Quality Management Systems of
Medical Device Manufacturers - Part 2: Regulatory Auditing Strategy
•DOC (264.5 KB)
•PDF (323.1 KB)
GHTF code: SG4(PD1)/N33 R13 - Date posted: 27 June 2006 19
ARCHIVED DOCUMENT
GHTF SG4 - Guidelines for Regulatory Auditing of Quality Systems of Medical Device
Manufacturers: General Requirements - Supplement No. 4 - Compilation of Audit
Documentation (Clause 5.7)
•DOC (61.5 KB)
•PDF (263.56 KB)
GHTF code: GHTF-SG4-(00)3 - Date posted: 24 February 2000
GHTF SG4 - Training Requirements for Auditors
•DOC (80 KB)
•PDF (43.22 KB)
GHTF code: GHTF.SG4.(99)14 - Date posted: 29 June 1999
GHTF SG4 - Audit Language Requirements
•DOC (57.5 KB)
•PDF (35.4 KB)
GHTF code: GHTF.SG4.(99)28 - Date posted: 29 June 1999
GHTF SG4 - Guidelines for Regulatory Auditing of Quality Systems of Medical Device
Manufacturers - Part 1: General Requirements
•DOC (150.5 KB)
•PDF (128.73 KB) 20
SCOPE

 This document provides guidance for auditing organizations

responsible for establishing, planning, carrying out, and
documenting audits of medical device manufacturers’ quality
management systems.
 The document also covers related requirements on the follow-
up of corrections, corrective, preventive, or improvement
actions, as applicable.
 In addition, it describes the competence criteria that the audit
team should meet.

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Purpose

The purposes of this document are:

• To harmonize and to provide guidance on
auditing quality management systems of
medical device manufacturers
• To help the auditing organization develop
their auditing procedures
• To assist auditors and auditees in preparing
for, facilitating and responding to audits

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GENERAL PRINCIPLES

Key Sections
1.Auditing Organization Requirements:
1. Must be impartial, competent, legally responsible, and capable of safeguarding
confidentiality.
2. Should document its organizational structure, implement a QMS, and ensure consistency in
audits.
2.Audit Team Competence:
1. Teams must have relevant knowledge of medical devices, regulatory standards, and quality
systems.
2. Auditors should have specific qualifications, training, and experience in areas like device
technology and regulatory frameworks.
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GENERAL PRINCIPLES

3. Audit Types:
•Full Audit: Comprehensive review, typically for initial
certifications.
•Partial Audit: Focused on specific subsystems or
processes.
•Surveillance Audit: Periodic checks to ensure ongoing
compliance.
•Special Audits: Triggered by significant changes or
identified risks.
•Combined/Joint Audits: Cover multiple regulatory
requirements or involve multiple organizations.
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GENERAL PRINCIPLES

4. Audit Process:

Preparation: Define scope, objectives, and criteria; appoint team; review QMS documentation.

Execution: Conduct opening meetings, collect evidence, and evaluate compliance.

Reporting: Prepare a detailed report highlighting findings, nonconformities, and

recommendations.

Follow-up: Monitor corrective actions and verify their effectiveness.

5. Audit Documentation:

Must include plans, records, findings, and reports sufficient to demonstrate compliance,

traceability, and the effectiveness of corrective actions. 25

TRAINING REQUIREMENTS FOR AUDITORS

1. Core Knowledge
•Auditors must understand the principles and
applications of quality management systems and
auditing, focusing on their relevance to medical
device manufacturers.
•They should be trained in effective auditing
techniques, including interviewing skills, collecting
and documenting evidence, and reporting findings
such as non-conformities.
•Familiarity with the policies, procedures, and
operational framework of the auditing organization is
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essential.
TRAINING REQUIREMENTS FOR AUDITORS
2. Regulatory Knowledge
•A deep understanding of the legal frameworks governing medical devices, including
compliance requirements and the role of auditing organizations.
•Knowledge of the essential principles of medical device safety, intended use, associated risks,
and key design and manufacturing processes.
•Specialized training may be required for high-risk or technical areas like sterilization methods,
in-vitro diagnostics, and tissue processing technologies.
3. Practical (On-the-Job) Training
•Trainees gain hands-on experience by observing audits conducted by experienced auditors,
progressively transitioning to active participation.
•They conduct supervised audits where mentors provide evaluations and constructive feedback.
•Continuous guidance from a mentor fosters expertise and helps refine auditing skills over time . 27
Overview of Typical Audit Process
Conduct on-site audit
Initiate the audit activities
- define audit objectives, scope
and criteria - conduct opening meeting
- establish initial contact with - communication during the
the manufacturer and/or audit
auditee - roles and responsibilities of
- appoint the lead auditor guides and observers
- determine the feasibility of - collect and verifying
the audit information

Prepare for the on-site audit

Conduct document review
activities
- prepare the audit plan, if
- review relevant management
appropriate as part of an
system documentation and
audit program
determining its adequacy with
- assign work to the audit team
respect to audit criteria
- prepare work documents
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Overview of Typical Audit Process

Prepare, approve and

distribute
the audit report
- prepare the audit report
- approve and distribute the
audit report

Complete the audit

Conduct audit follow-up

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Auditing Subsystems

1. Management:
GOAL: The purpose of the management subsystem audit is to evaluate whether top
management ensures that an adequate and effective quality management system has been
established and maintained.
2. Corrective and Preventive Actions – CAPA
GOAL: The purpose of auditing the CAPA subsystem (including reporting/tracking) is to
confirm that information is collected and analyzed to identify actual and potential product
and quality problems, that these are investigated, and appropriate and effective corrective and
preventive actions are taken.

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Auditing Subsystems

3. Design and Development

GOAL: The purpose of auditing the design and development subsystem is to determine
whether the design and development process is controlled to ensure that medical devices
meet user needs, intended uses and specified requirements.
4. Product Design Documentation
GOAL: The purpose of auditing the Product Design Documentation is to confirm that the
manufacturer’s documentation is complete to ensure that products meet customer and
regulatory requirements.
5. Production and Process Controls
GOAL: The purpose of auditing the production process (including testing, infrastructure,
facilities and equipment) is to confirm that the production process is able to ensure that the
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products will meet specifications.
Auditing Subsystems

Documentation and Records

GOAL: The purpose of auditing the documentation and records is to ensure that the relevant
documents are controlled within the manufacturer, and critical suppliers covered by the
scope of this audit, and that the relevant records are available.
Customer Related Process
GOAL: The purpose of auditing customer related processes is to ensure that customer
requirements including regulatory requirements are met.

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REFERENCES:

Websites:

• https://www.imdrf.org/

Website PDF
• https://www.imdrf.org/sites/default/files/docs/ghtf/final/sg4/technical-docs/ghtf-sg4-
n30r16-2005-regulatory-auditing-device-manufacturer-050915.pdf

• https://www.imdrf.org/sites/default/files/docs/ghtf/archived/sg4/technical-docs/ghtf-
sg4-guidelines-auditing-qms-part-1-general-requirements-080827.pdf

• https://web.archive.org/web/20061006202911/http://www.ghtf.org/sg4/inventorysg
4/trainingfinal.pdf

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THANK
YOU

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