Global Harmonization Task Force (GHTF) and International Medical Device Regulators Forum (IMDRF)

GURU NANAK INSTITUTE OF PHARMACEUTICAL SCIENCE AND
TECHNOLOGY (An Autonomous Institute)
TOPIC : Global Harmonization Task Force and
International Medical Device Regulators Forum
Affiliated to Maulana Abul Kalam Azad University of
NAME: Pushpita Das
Roll Number: 186152401005
ACEDAMIC SESSION: 2024-2025
PAPER NAME: Regulatory
Aspects of Medical Devices
PAPER CODE: R20_MRA203T
27/02/2025

INDEX
SL NO TOPIC SLIDE NO
1 GHTF 3
2 Organizational Structure 4
3 Classification Medical Device 5
4 Study Group 6
5 Summary Technical Document (STED) 8
6 GHTF Guidelines 9
7 Benefits of IMDRF over GHTF 10
8 International Medical Device Regulators Forum 11
9 Working groups 12
10 IMDRF Management Committee 13
11 Reference 14
M. PHARM (Regulatory Affairs)/ SEM 2/2024-25/R20_MRA203T/GHTF & IMDRF
27/02/2025

3
Canada
USA
European Union
Japan
Australia
GHTF
• The Global Harmonisation Task Force (GHTF) was a partnership between
regulatory authorities and the medical device industry. It was established in
1992 to improve patient safety and increase access to medical technologies. [1]
• The GHTF was replaced by the International Medical Devices Regulators
Forum (IMDRF) in 2012. These devices vary widely in type and are highly
essential for patient’s care, their manufacture, distribution, and sale must be
regulated to ensure their quality, safety, and efficacy.
• A medical device is any instrument, apparatus, machine, appliance, implant,
reagent for in vitro use, software, material, or related article used for a specific
medical purpose.[2]
• To ensure the safety, efficacy and effectiveness and useful medical
technologies and to also increase the uniformity between the national medical
device regulatory system. [8]
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4
Organizational Structure
Chair’s Advisory Group Ad Hoc Working Group Steering Committee
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.
Ad Hoc Working Groups may be
formed at any time by the Steering
Committee for the proper fulfilment
of its tasks.
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.
Advisory committees serve a vital
function in providing informed
perspectives and advice.
Their role extends beyond simple
counsel as they are also instrumental
in shaping strategy, identifying risks,
and promoting effective governance.
They conduct advisory committee
meetings at least annually and
conduct special advisory committee
meetings as necessary.
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5
Class A
Class D
Class C
Class B
• Low individual Risk
• Low Public Health
Risk
• Moderate
Individual Risk
• Low Public Health
Risk
• High individual Risk
• Moderate Public
Health Risk
• High Individual Risk
• High Public Health Risk
Clinical chemistry analyser
Pregnancy self- testing
Urine test strips
Blood Glucose self Testing
HIV Blood diagnostic
Surgical Dressing
Alcohol Swabs
BP monitoring device
Pacemaker Cochlear implants
Cardiovascular monitor Catheter
[1,7]
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01
02
03
04
05
Study Groups
Pre-market
Principles of
classification and
conformity assessment
Post-market
Set of task and
queries for post
market surveillance
QMS
Examining existing
quality system
requirements
Audit
Laying principles for
the medical device
auditing process.
Clinical Safety
Requirements for
evidence of the clinical
safety and performance
of medical devices
[2,5]
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7
Application of the GHTF guidance documents during a medical device lifecycle
10
Audits
-
Internal
and
External
Certification
Coverage
of
the
complete
quality
management
system
QMS
and
Risk
Management
are
applicable
throughout
the
complete
product
life
cycle
(including
managing
changes
[10]
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8
SUMMARY TECHNICAL DOCUMENTATION (STED)
The GHTF has identified as a priority the need to harmonize the documentation of evidence of conformity to the
Essential Principles of safety and performance (hereafter referred to as Essential Principles).
This guideline provides recommendations on the content of summary technical documentation (STED) to be
assembled and submitted to a Regulatory Authority or Conformity Assessment Body.
The use of the STED should reduce costs for the manufacturer and reviewer, remove barriers to trade and
facilitate timely international access to IVD medical devices.
Purpose
This document is intended to provide guidance
on the content of the STED for IVD medical
devices to be assembled and submitted, where
applicable, for premarket review, and for use
post-market to assess continuing conformity to
the Essential Principles.
CONTENTS OF THE STED
Device Description
Device Variants (Configurations) and Accessories
Reference to the Manufacturer’s Previous Device Generation(s)
and/or Similar Devices or Device History
(a) For an medical device not yet available on any market
(b) For an medical device already available on the market in
any jurisdiction
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The GHTF provided the
guidance on mandatory
reporting of adverse events
for device manufacturers
and voluntary reporting for
users. Also, the
manufacturer must decide
the reportability of adverse
events on the basis of
information available.
Adverse event
reporting
GHTF requires
immediate reporting by
the manufacturer of
unanticipated death,
serious injury, or public
health threat as soon as
possible, but no later
than 30 calendar days
following the date of
awareness of the event.
Reporting
time frame
Ensuring that the
products are reliable,
perform as intended, and
do not pose a risk to
either patients, operators,
or the environment.
Lessen the likelihood of
an error occurring in the
product by taking various
preventative measures.
Risk
Management
If a complaint about a
defect is not justified,
then it is considered a
failure of the quality
system and immediate
corrective action is
undertaken by a
product recall.
Recall
GHTF GUIDELINES [9]
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10
IMDRF addresses the needs of a more
diverse set of countries, enabling more
inclusive and globally relevant regulatory
frameworks.
IMDRF is more adaptable to emerging
technologies and global trends in
healthcare innovation.
Addresses newer challenges, such as
cyber security, software as a medical
device (SaMD), and artificial intelligence
(AI) in medical devices.
Organizes working groups based on
priority topics, allowing flexibility in
addressing specific regulatory challenges
as they arise.
Collaborates with global organizations like the
World Health Organization (WHO) and the
Asia-Pacific Economic Cooperation (APEC),
enhancing its reach and impact.
Operates with clear regulatory authority
oversight, which ensures accountability to
public health priorities.
IMDRF is more adaptable to emerging
technologies and global trends in
healthcare innovation.
IMDRF ensures a more focused approach to
global regulatory harmonization that aligns with
public health goals and government policies.
BENIFITS OF IMDRF OVER GHTF
[6,1]
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International Medical Device Regulators Forum
• IMDRF is a voluntary group of medical device regulators from
around the world who have come together 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 and
convergence.
• IMDRF was established in October 2011, 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 to address the establishment and operation of this new
Forum.
• The World Health Organization (WHO) and Argentina are
Official Observers. The Asian Harmonization Working Party
(AHWP), Pan American Health Organization (PAHO) and
APEC LSIF Regulatory Harmonization Steering Committee are
IMDRF Regional Harmonization Initiatives.
Japan, Pharmaceuticals and Medical Devices Agency
and the Ministry of Health, Labour and Welfare
European Union, European Commission - Directorate-
General for Health and Safety
China, National Medical Products Administration
Canada, Health Canada
Brazil, Brazilian Health Regulatory Agency
(ANVISA)
Australia, Therapeutic Goods Administration
Russia, Russian Ministry of Health
South Korea, Ministry of Food and Drug Safety
United States of America, US Food and Drug
Administration
United Kingdom, Medicines and Healthcare products
Regulatory Agency
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Working groups
• Working Groups are responsible for
developing technical documents, and
generally involve the participations that have
significant involvement in the development,
manufacture or use of medical device.
• They prepare guidelines and documents for
their respective working group.
Participants:
 Stakeholders
 regulated industry
 international entities
 Associations
 consumer groups
 medical professionals
 other regulatory authorities.

13
Management Committee
•The IMDRF Management Committee,
composed of regulatory officials, provides
guidance on strategies, policies, directions,
membership and activities of the Forum.
•Furthermore, the Management Committee
oversees working groups, which draw upon
expertise from various stakeholder groups such
as industry, academia, healthcare professionals,
consumer and patient groups.
•The roles of IMDRF Chair and Secretariat rotate
annually.
Official Observers
• The Management Committee may designate a
limited number of Official Observers to the
Management Committee from the World Health
Organization and other regulatory authorities on
the basis of perceived contribution or value to
IMDRF.
• Official Observers do not participate in the
decision making process.
• Official Observers must be approved by the
unanimous consent of the Management
Committee and, as with Members, need to be fully
knowledgeable on IMDRF matters.
• IMDRF Official Observer Representatives
• Argentina -- National Administration of Drugs,
Food and Medical Devices
• World Health Organization (WHO)
• Saudi Food and Drug Authority
• Switzerland - Swiss Agency for Therapeutic
Products (Swissmedic)
27/02/2025

1. Nannepamu, P. B., Kumar, T. N. P., Ram, P. S., Nagabhushanam, G. R., Bonthagarala, B., Sindhu, Y.
R., & Ch, S. K. (2022). REGULATORY APPROVAL PROCESS FOR MEDICAL DEVICES IN INDIA,
USA & EUROPEAN UNION. (pg-3,4)
2. Beckers, R., & Van Hoydonck, P. (2023). Impact of the Regulatory Framework on Medical Device
Software Manufacturers: Are the Guidance Documents Supporting the Practical Implementation?:
Comment on". International Journal of Health Policy and Management, 12.(pg 45,46)
3. Saifuddin, P. K., Prakash, A., Samujh, R., Gupta, S. K., Suri, V., Kumar, R. M., ... & Medhi, B. (2021).
Pattern of Medical Device Adverse Events in a Tertiary Level Hospital in Northern India: An
Ambispective Study.(pg- 22-30)
4. The Global Harmonization Task Force (GHTF). Medical devices post market surveillance: global
guidance for adverse event reporting for medical devices [internet]. [place unknown]: GHTF; 2006
[cited 2023 Sep]. https
://www.imdrf.org/sites/default/files/docs/ghtf/final/sg2/technical-docs/ghtf-sg2-n54r8-guidance-advers
e-events-061130
(pg-6-9)
5. Khan, M. I., & Sharma, T. From Aspiration to Affiliation in IMDRF By 6 Countries (Egypt, Cuba, Chile,
Montenegro, Israel And Chinese Taipei) And Investigating the Absence of India.
6. Khinvasara, T., Ness, S., & Tzenios, N. (2023). Risk Management in Medical Device Industry. J. Eng.
Res. Rep, 25(8), 130-140.
7. Patil, R. S., Mahajan, H. D., Shaikh, T., Chavan, N. C., Chaudhari, A. A., & Bhadane, H. Y. (2024). A
REVIEW ON MEDICAL DEVICE REGULATION BY VARIOUS REGULATORY AGENCIES.
8. The Global Harmonization Task Force (GHTF). Review of current requirements on postmarket
surveillance [internet]. [place unknown]: GHTF;2005 https://
www.imdrf.org/sites/default/files/docs/ghtf/final/sg2/technical-docs/ghtf-sg2-n47r4-2005-guidance-pos
REFERENCE
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M. PHARM/ SEM 1/2024-25/ Seminar/ R20_MRA106/ GHTF
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Global Harmonization Task Force (GHTF) and International Medical Device Regulators Forum (IMDRF)

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