It is a voluntary group of medical device regulators from around the world.

1. IMDRF/GHTF
MRA 203T
UNIT 1
Under the guidance of
Dr. Lakshmi Prasanthi Nori
Professor
Department of Regulatory Affairs
Presented by:
Sheik Rehana
1st M. Pharmacy (Regulatory Affairs)
Reg no: 222309
Shri Vishnu College of Pharmacy

2. INTERNATIONAL MEDICAL DEVICE REGULATORS FORUM (IMDRF)
 IMDRF is a voluntary group of medical device regulators from around the world.
 It has come up to build on the strong foundational work of the Global Harmonization
Task Force on Medical Devices (GHTF) and aims to accelerate international medical
device regulatory harmonization.
 IMDRF was established in October 2011.
 The establishment and operation of this new Forum was addressed when
representatives from the medical device regulatory authorities of Australia, Brazil,
Canada, China, European Union, Japan and the United States, as well as the
World Health Organization (WHO) met in Ottawa.

3. THE CURRENT IMDRF MANAGEMENT COMMITTEE MEMBERS AND
REGULATOR AUTHORITY :
1) Australia – Therapeutic Goods Administration
2) Brazil – Brazilian Health Regulatory Agency
3) Canada – Health Canada
4) China – National Medical Products Administration
5) European Union – European Commission – Directorate - General for Health and Food Safety
6) Japan – Pharmaceutical and Medical Devices Agency (PMDA)
7) Russia – Russian Ministry of Health
8) Singapore – Health Science Authority
9) South Korea – Ministry of Food and Drug Safety
10) United Kingdom – Medicines and Healthcare Products Regulatory Agency
11) United States of America – US Food and Drug Administration

4. REGIONAL
HARMONIZATION
INITIATIVES
The Asia Pacific Economic Cooperation (APEC) Life Sciences
Innovation Forum’s (LSIF) regulatory harmonization steering
committee
Asian Harmonization Working Party (AHWP)
Pan American Health Organization (PAHO)
OFFICIAL OBSERVERS
Argentina, National Administration of Drugs, Food
and Medical Devices
World Health Organization (WHO)
Swissmedic

5. IMDRF CHAIR AND SECRETARIAT
 The IMDRF Chair and Secretariat rotate on a yearly basis across Management Committee members.
 The European Union currently holds this responsibility for the year of 2023.
 Upcoming rotations are as follows:
• 2024 - USA
• 2025 - Japan
• 2026 - Singapore
• 2027 - Brazil
• 2028 - Canada
• 2029 - UK
• 2030 - China

6. IMDRF MANAGEMENT COMMITTEE (MC) MEETINGS
 The IMDRF Management Committee (MC) meets four times a year with Closed
Session meetings generally held in January, March, June and September.
 The IMDRF MC may also meet as required if an extraordinary event occurs.
 They also holds three successive plenary sessions in March and September each
year corresponding with the IMDRF MC Closed Sessions.
 The IMDRF MC Members are expected to attend these face-to-face meetings.

7. GLOBAL HARMONIZATION TASK FORCE (GHTF)
 The GHTF was conceived in 1992 and is an informal grouping that was formed to
respond to the growing need for the international harmonization of regulations in
medical devices.
 Since its inception, the GHTF was comprised of representatives from five founding
members grouped into three geographical areas: Europe, Asia-Pacific and North
America, each of which actively regulates medical devices using their own unique
regulatory framework.
 The five Founding Members are: European Union, United States, Canada,
Australia and Japan.
 The GHTF disbanded late in 2012. Its mission has been taken over by IMDRF.
 The organization GHTF, no longer exists.

8. FOUNDING MEMBERS

9. ORGANIZATION STRUCTURE
Chair's
Advisory Group
Ad Hoc
Working Group
Steering
Committee

10. A. CHAIR’S ADVISORY GROUP (CAG)
 Ms. Beth Pieterson from Health Canada, volunteered to chair the Ad Hoc Procedures Group (as it came
to be called) as part of her role as incoming GHTF Chair.

11. The existence of the European proposal prompted the GHTF Chair, Dr. Elizabeth Jacobson, to propose the establishment of a joint
industry and regulatory working group to examine the issues of document development, organizational structure, etc.
The group would be asked to review all the existing procedural documents and comments and to propose a defined set of practices and procedures
whose adoption could be discussed at the 8th Meeting of the GHTF
The second meeting of the CAG was held during the 7th Meeting of the GHTF in June 1999
Regulatory representatives from Japan,
Australia, the United States, Canada and the
European Union were present.
At that meeting, a second draft of the GHTF Guiding Principles and Operating Procedures
document was presented and representatives from the European Union also presented a
proposal for the organizational structure of the GHTF.
The inaugural meeting of the Chair’s Advisory Group (CAG) was held in Washington, DC on 16-17 February 1999.
At that meeting, plans and agendas were made for the 7th
Meeting of the GHTF, which was in the month of June of
that year (1999) in Bethesda, Maryland.
The group was introduced to a draft document which is prepared by the Food and Drug
Administration (FDA) entitled GHTF Guiding Principles and Operating Procedures
which proposed an organizational structure for the GHTF and procedures to be followed
for document advancement.

12. B. AD HOC WORKING GROUPS
 Ad Hoc Working Groups may be formed at any time by the Steering Committee for the proper
fulfilment of its tasks.
 Ad Hoc Working Groups shall be appointed by the GHTF Chair with the agreement of the Steering
Committee.
 Members of Ad Hoc Working Groups should represent GHTF Founding Members, Regional Members
or Participating Members.
 In some cases, the Ad Hoc Working Group Chair may authorize an individual, with appropriate
knowledge and expertise, to participate in an Ad Hoc Working Group meeting(s) as an external
observer/expert.

13. C. STEERING COMMITTEE
 The GHTF Steering Committee is established under the Procedural Document, "Roles and
Responsibilities".
 The role of the Steering Committee is to provide policy direction, strategic planning, and to assign
and provide oversight of technical work initiatives".
 Representation on the Steering Committee is limited to up to 4 regulatory and 4 industry members from
each founding geographic area - Europe, North America and the Asia-Pacific.
 The inaugural Steering Committee meeting was held during early 2001 in Sydney, Australia.
 And it was hosted by the new GHTF Chair (as at January 2001), Ms. Rita Maclachlan of Australia's
Therapeutic Goods Administration.

14. GHTF PURPOSE
 These representatives working with medical device manufacturers and other
organizations related to medical devices try to harmonize global approaches to the
safety, efficacy, clinical performance, and quality of medical devices with the goal
of -
• protecting public health,
• promoting innovation, and
• facilitating international trade.

15. FUNCTIONS
Encouraging the
participation of countries
and economies other
than those of the
Founding members and
those represented by the
Regional Members.
Resolving all disputes
regarding GHTF decisions
or actions brought
forward by GHTF
members or persons
outside the GHTF, with
the assistance of the
Steering Committee.
Representing the GHTF in
ad hoc consultations with
external parties
concerning GHTF
activities.
Appointing and renewing
Study Group Chairs, Vice
Chairs and Ad Hoc
Working Group Chair.
Endorsing final GHTF
guidance documents and
encouraging their
implementation.
Monitoring and
modifying the
institutional rules and
procedures of GHTF as
needed and in particular
the composition of the
Steering Committee.
Granting status of
Regional Members,
Participating Members
and Liaison Bodies.

16. WORKING GROUPS
 Active working groups
1. Adverse event terminology
2. Good regulatory review practices
3. Medical device cybersecurity guide
4. Personalized medical devices
5. Regulated product submission
6. Software as a medical device
 Closed working groups
1. Artificial Intelligence Medical Devices
2. Clinical Evidence for IVD Medical Devices
3. Integrating patient registries and innovative tools for
enhanced medical device evaluation and tracking
4. Medical Device Clinical Evaluation
5. Principles of In Vitro Diagnostic (IVD) Medical
Devices Classification
6. Unique Device Identification (UDI) Application Guide
7. Standards - Improving the quality of international
medical device standards for regulatory use

17. The purpose of this working group is to:
•Improve and harmonize the terminology and
systems that are being used to code information
relating to medical device adverse events.
•To establish IMDRF adverse event terminology
composed of the following three parts:
i. terms for medical device malfunction,
ii. terms for patient/user outcome and
iii. terms for part/component of medical
device.
1. Adverse Event Terminology
• This Good Regulator Review Practices
(GRRP) working group develops guidance
which help to establish good regulatory
review practices for Regulatory Authorities
and/or their Conformity Assessment Bodies.
• The Review Practices (GRRP) working
group aims to improve the effectiveness and
efficiency of pre-market review.
2. Good Regulatory Review
Practices
ACTIVE WORKING GROUPS

18. • Medical devices have a potential to impact
patient safety. Cybersecurity incidents have
made medical devices and hospital networks
inoperable, disrupting the delivery of patient care
across healthcare facilities worldwide.
• The purpose of this Work Item is to promote a
globally harmonized approach to medical
device cybersecurity, which ensures the safety
and performance of medical devices from
fundamental level while encouraging
innovation.
• The Work Item is thus intended to provide
medical device cybersecurity guidance for
stakeholders across the device lifecycle.
3. Medical Device Cybersecurity
Guide • Advancement in materials science, computational power,
imaging and manufacturing technologies are useful in
producing medical devices that are designed to meet an
individuals needs. These are known as personalized medical
devices or PMDs.
• The purpose is to develop guidance documents for providing
harmonized recommendations for the regulation of PMDs.
• The adoption of consistent and harmonized requirements for
PMDs will offer significant benefits to users, patients,
manufacturers, and regulatory authorities.
• The Working Group is currently developing an IMDRF
Technical Document which will provide recommendations for
production validation of PMDs. The document will provide
technical guidance on:
i. Validation of the specified design envelope that is one of
the defining features of a patient-matched medical
device
ii. Validation of a Medical Device Production System
4. Personalized Medical
Devices (PMD)

19. The purpose of this working group is to build -
•Table of Contents for medical device
regulatory submissions and
•To create a template that supports the
electronic transmission of regulatory
submissions.
5. Regulated Product
Submission
• The importance of software for medical purposes
is increasing in the advancement of public
health.
• The goal of the Software as a Medical Device
(SaMD) Working Group (WG) is to review and
refine, the previously published documents, as
needed. This is done to ensure:
i. consistency, predictability, transparency,
and quality of premarket regulatory
programs and
ii. criteria for assessing premarket technical
documentation for SaMD.
• The review also pays attention to post-market
activities, and also recognizes the speed with
which digital health technology develops.
6. Software as a Medical Device

20. STUDY GROUP
• Premarket Evaluation
STUDY GROUP 1
• Post-Market Surveillance/Vigilance
STUDY GROUP 2
• Quality system
STUDY GROUP 3
• Auditing
STUDY GROUP 4
• Clinical safety/performance
STUDY GROUP 5

21. REGULATORY GUIDELINES
1. Principles of Conformity Assessment for Medical Devices:
 Conformity assessment is conducted before and after a medical device is placed on the market,
and post-market surveillance of devices in actual use.
 They are intended to provide the evidence of safety, performance, and benefits and risks to
maintain public confidence.
 Conformity assessment is primarily the responsibility of the medical device manufacturer.
STUDY GROUP 1

22. DEFINITIONS:
 Conformity Assessment: The systematic examination of evidence generated and procedures undertaken by
the manufacturer, under requirements established by the Regulatory Authority, to determine that a medical
device is safe and performs as intended by the manufacturer and, therefore, conforms to the Essential
Principles of Safety and Performance for Medical Devices.
 Conformity Assessment Body (CAB): A body, other than a Regulatory Authority, engaged in determining
whether the relevant requirements in technical regulations or standards are fulfilled.
Conformity
Assessment
Elements:
a)Quality
management
system (QMS)
System for post-
market
surveillance
Technical
documentation
Declaration of
conformity
Registration of
manufacturers
and their
medical devices
by the RA

23. PURPOSE:
IT PROVIDES
GUIDELINES ON:
the evidence and procedures that may be used by the manufacturer to demonstrate
that a medical device is safe and performs as intended by the manufacturer.
the conformity assessment elements that apply to each class of device as the
regulatory demands increase with the hazard presented by a particular medical
device;
the process by which a RA/CAB(Regulatory Authority / Conformity Assessment
Bodies) may confirm that such elements are properly applied by the manufacturer;
and
the manufacturer’s written attestation that it has correctly applied the conformity
assessment elements relevant to the classification of the device, i.e. the “Declaration
of Conformity”.

24. 2. Principles of Medical Devices Classification:
 To provide a series of principles and rules that allow a medical device to be assigned to one
of four classes based on its intended use:
CLASS LEVEL DEVICE EXAMPLES
A Low Hazard Bandages / tongue
depressors
B Low-moderate Hazard Hypodermic Needles /
suction equipment
C Moderate-high Hazard Lung ventilator / bone
fixation plate
D High Hazard Heart valves /
implantable
defibrillator

25. Structure of the Classification Rules
1. RAs should establish a device classification system consisting of four classes where Class A represents the lowest hazard
and Class D the highest.
2. The determination of class should be based on rules derived based on the hazard it presents and based on its intended use.
3. These rules should allow a manufacturer to readily identify the class of its particular medical device subject.
4. The rules should be capable of accommodating future technological developments.
5. The manufacturer should document its justification for placing its product into a particular class.
6. If, based on the manufacturer’s intended use, two or more classification rules apply to the device, the device is allocated
the highest level of classification indicated.
7. Where one medical device is intended to be used together with a different medical device, that may or may not be from
the same manufacturer, (e.g. a pulse oximeter and a replaceable sensor sourced from a different manufacturer, or a
general purpose syringe and a syringe driver), the classification rules should apply separately to each of the devices.

26. STUDY GROUP 2
XML (Extensible Markup Language)
Schema for Electronic Transfer of
Adverse Event Data
This XML schema has been
developed to facilitate a
harmonized method for
exchanging an adverse event
dataset electronically.
National Competent Authorities
and manufacturers are
encouraged to use this
internationally agreed XML
schema for exchanging adverse
event data.
The XML schema allows adverse
event data to be completed in
English and/or, where necessary, in
the language required by the
relevant National Competent
Authorities.
Medical Devices Post Market
Surveillance
It provides guidelines on:
the criteria to be used for
deciding when to exchange
information with other national
competent authorities
the procedures to follow when
exchanging information
the forms to use for
exchanging the information
Guidance - Content of Field Safety
Notices
This document identifies
elements that should and
should not be included in
safety related notifications
issued by the medical
device manufacturer or its
representative.

27. STUDY GROUP 3
 Quality management system - Medical devices - Nonconformity Grading System for
Regulatory Purposes and Information Exchange
 Quality management system - Medical Devices - Guidance on corrective action and
preventive action and related QMS processes
 Quality Management System - Medical Devices - Guidance on the Control of Products and
Services Obtained from Suppliers
 Risk Management Principles and Activities within a QMS
 QMS - Process Validation Guidance

28. STUDY GROUP 4
This gives guidance to regulators and auditing organizations conducting audits of quality
management systems of medical device.
Scope : This document provides guidance to auditing organizations on planning,
organizing, conducting, documenting, and reviewing audit programs for auditing a medical
device.
To harmonize and provide guidance on planning, organizing, conducting, documenting,
and reviewing an audit program for auditing a manufacturer with multiple sites
To assist auditors and manufacturers in preparing for, facilitating and
responding to audits involving multiple sites
To improve the efficiency of audits of a quality management
system of a manufacturer with multiple sites
Purpose :

29.  Potential benefits of this document for the regulators or auditing organizations and
manufacturer of medical devices include:
 Improved efficiency of an audit of a quality management system of a manufacturer
with multiple sites
 Reduced audit time and cost for the auditing organization
 Provision of guidelines for initial audit, surveillance audit, and special audit of a
quality management system of a manufacturer with multiple sites

30. STUDY GROUP 5
The broad goal for Study Group 5 is to promote the convergence of the regulatory
requirements for the generation and presentation of evidence of the clinical safety and
performance of medical devices.
Clinical investigation -
A clinical investigation is defined as “any systematic investigation or study in or on one or
more human subjects, undertaken to assess the safety and/or performance of a medical
device.”
• ISO 14155-1:2003 Clinical Investigation of Medical Devices for Human Subjects
Clinical evaluation: The assessment and analysis of clinical data pertaining to a medical
device to verify the clinical safety and performance of the device when used as intended by
the manufacturer.

32. CONCLUSION
 The IMDRF (International Medical Device Regulators Forum) and GHTF (Global Harmonization Task
Force) play vital roles in advancing global medical device regulations and harmonization efforts. These
organizations have significantly contributed to enhancing patient safety, promoting innovation, and
facilitating international trade in the medical device industry. To deliver key objectives, IMDRF has
prioritized work on: 1. Pre-market 2. Post-market 3. Relationships with stakeholders. By staying at the
forefront of regulatory innovation, the IMDRF/GHTF will ensure that patients worldwide have access
to safe and effective medical devices.

33. QUESTIONS
1. Discuss in detail about GHTF/IMDRF.
2. Write about the organization structure and functions of IMDRF.
3. What are the active working group in IMDRF?

34. REFERENCES
 https://www.imdrf.org/
 https://www.imdrf.org/ghtf/mission-summary
 https://www.imdrf.org/working-groups

35. THANK YOU