knowledge towards medical devices and IVDS Of GLOBAL HARMONIZATION TASK FORCE

1. Medical Devices and IVDs
Global HarmonizationTask Force
NAME : K . SriDivya
ROLLNO: 6212095205
COURSE: M-Pharmacy
BRANCH : Pharmaceutical
Regulatory Affairs

2. INTRODUCTION:
• GHTF was founded in the year 1993 by the government and industry
representatives of Australia ,Canada , Japan ,US and the European
Union.
• GHTF is to encourage convergence at the global level in the evolution
of Regulatory systems for medical devices in order to facilitate trade
while preserving the right of participating members to address the
protection of public health by Regulatory means to considered to be
most suitable.

3. OBJECTIVES:
• Medical devices like drugs are used world wide with the rapid growth
in the global market .
• For medical device there is need to harmonize national standards in
order to minimize regulatory barriers ,facilitate trade & improve new
technologies.
• Harmonization also reduce the cost by implementing regulations for
government and local industry.

4. GOALS:
• The primary way in which GLOBAL HARMONIZATION TASK FORCE
(GHTF) achieves its goal is through production of harmonized
guidance documents suitable for implementation or adoption by
members in Regulatory authorities ,as appropriate taking into account
their existing legal framework , or by nations with developing
programmes.
• This guidance document is one of a series that together describe a
global regulatory model for Medical Devices.

5. PURPOSE:
• Its purpose is to assist manufacturer to allocate it’s In Vitro
Diagnostic(IVD) medical device to an appropriate risk class using a set
of harmonized principles.
• The GHTF document has principles of conformity Assessment for IVD
Medical devices that contains each of the four risk classes.
• The link between development of documents on classification and
conformity assessment is important to ensure a consistent approach
across all countries adopting the global regulatory model
recommended by GHTF. So that premarket approval for a particylar
device acceptable globally.

6. SCOPE:
• GHTF document applies to all products that fall within the definition
of an IVD medical devices .An IVD medical device is defined as a
device which, whether used alone or in combination ,is intended by
the manufacturer for the in-vitro examination of specimens derived
from human body or to provide information for diagnostic,
monitoring or compatibility purposes materials . This includes
reagents , calibrators, control materials ,soft ware ,and related
instruments and apparatus.

7. USES OF IVD medical devices
• Diagnosis , prevention ,monitoring , treatment , or alleviation of
disease.
• Investigation , replacement , modification , or support of the anatomy
or of a physiological process,
• Supporting or sustaining life,
• Aids for persons with disabilities,
• Disinfection of medical devices ,
• Providing information by means of in vitro examination of specimens
derived from the human body.

8. Classification of IVD medical device based on
following criteria:
• The intended use and indications for use as specified by the
manufacturer
• The technical/ scientific/medical expertise of the intended user
• The importance of the information to the diagnosis , taking into
consideration the natural history of disease including signs and
symptoms which may guide a physician
• The impact of result to the individual or to public health.

9. 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

10. General Classification system for IVD Medical
Devices
• General classification
class Risk Level Examples
A Low individual Risk and Low Public
Health Risk
Clinical chemistry analyser, prepared
selective culture media
B Moderate Individual Risk and Low
Public Health Risk
VitaminB12, Pregnancy self- testing,
Anti- Nuclear Antibody, Urine test strips
C High individual Risk and Moderate
Public Health Risk
Blood Glucose self Testing, HLA Typing,
PSA Screening ,Rubella
D High Individual Risk and High Public
Health Risk
HIV Blood donor screening, HIV Blood
diagnostic

11. • Risk Based Classification:
class Risk Level Device Examples
A Low Surgical retractors/tongue depressors
B Low-Moderate Surgical retractors/tongue depressors
C Moderate-High Lung Ventilators /Orthopaedic implants
D High Heart Valves / Implantable defibrillators

12. Classification Rules:
A) 16 General
Rules
• .Non-Invasive Devices (1-4)
• Invasive Devices (5-8)
• Active Devices (9-12)
• Additional Rules(13-16)
B)Other
important
additional
Rules
• Rules (1-7)

13. 16 General rules
• Rule-1 : in contact with injured skin and intended as a barrier
• Rule -2: channel or store liquids /tissues/gases intended for infusion
• Rule -3: Modify biological or body liquids intented for infusion
• Rule -4 :Device or other than those where rules 1,2or3 apply
• Rule-5: Invasive through body orifice
• Rule -6: Surgically invasive – transient use
• Rule -7: Surgically invasive – short term use
• Rule -8 : Surgically invasive – long term use implants

14. • Rule -9: Active therapeutic devices intended to administer or
exchange energy
• Rule-10: Active diagnostic device
• Rule -11:Active device to administer or remove medicinal products &
other substance from the body
• Rule- 12:Active devices other than those were in Rules 9,10or11 apply
• Rule-13:Device incorporating medicinal product which has ancillary
action
• Rule-14: Device manufactured from or incorporating humans or
animal tissue
• Rule-15: Device intented specifically for sterilization of medicaldevices
• Rule-16:Device used for Contaception

15. no Rule Purpose
Rule-1 IVD medical devices intended for
following purpose are in class D
Device is used to detect presence of transmissible agent in
blood ,cells ,tissues &organs
Detect agents that causes life threatening ,disease with high risk
propagation
Rule-2 IVD medical devices intented used
for blood load and HIV Viral load
In screening of congenial disorders in the foetus .
Examples: spina bifida or down syndrome
Rule-3 IVD medical devices intented for
following purpose are in class C
Detecting the STD, detecting the infectious agents in blood and
cerebrospinal fluid &prenatal screening of women for their
immune status
Rule-4 IVD medical devices intented for
self testing are in class C
Blood Glucose Determination
Rule-5 IVD medical devices intented for
following purpose are in class D
Reagents used for specimen examination
Instruments intended by the manufacturer used for In- Vitro
diagnostic purpose
Other important additional Rules:
Rule-6 IVD medical devices not covered
in Rule 1
Physiological markers such as harmones, vitamins, enzymes and
metabolic markers.
Rule-7 IVD medical devices that are
controls without a quantitative
value assigned in class B
Qualitative and quanititative that are assigned by the users not
manufactures

16. Conclusion:
• By using an internationally recognized risk classification scheme for
IVDs to determine routine regulatory oversight, regulatory authorities
and conformity assessment bodies ensure that the level of
assessment is proportionate to the degree of risk, taking into account
the benefits offered by the IVD. Such an approach to IVD assessment
takes into account the number and diversity of IVDs .
• WHO recommends the adoption of this approach for WHO Member
State regulating IVDs and those considering doing so. Because of its
international acceptance , WHO undertakes PQ assessment activities
according to the risk class as determined by applying the GHTF
classification rules.

17. Reference
• GHTF/SGI/N044:2008 Role of standards in the assessment of Medical
Devices.
• GHTF/SGI/N029:2005 Information Document Concerning the
Definition of Term “Medical Devices”.
• GHTF/SGI/N041:2005 Essential Principles of Safety and Performance
of Medical Devices.
• GHTF/SGI/N043:2005 Labelling for Medical Devices.
• GHTF/SGI/N046:2008 Principles of conformity Assessment For In
Vitro Diagnostic (IVD) Medical Devices.

18. THANK YOU