MOH / P / PAK / 204.

10 (GU)

STANDARDS FOR ASSISTED

REPRODUCTIVE TECHNOLOGY
FACILITY - EMBRYOLOGY LABORATORY
AND OPERATION THEATRE

MEDICAL DEVELOPMENT DIVISION

MINISTRY OF HEALTH
MALAYSIA

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 The Standards For Assisted Reproductive Technology (ART) was prepared by
Standards For ART Laboratories Working Committee, Medical Development
Division, Ministry of Health and is based on Laboratory Accreditation Scheme of
Malaysia (SAMM), STR 2.7 Specific Technical Requirements For Accreditation Of
Assisted Reproductive Technology (ART) Laboratories, Issue 1, 30 August 2008
published by Department of Standard Malaysia, with their kind permission via
JSM/AD-700/01/09 dated 27 July 2010.

Published in October 2012

No part of this publication may be reproduced or distributed in any form or any

means, or stored in a database or retrieval system, without prior written permission
of the Ministry of Health.

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 CONTENTS

Foreword By Director General Of Health Malaysia 2

1. Introduction 4

2. Scope Of ART Services For Accreditation 4

3. Terms And Definitions 4

4. Technical Requirements 5

4.1 Personnel 5

4.2 Accommodation And Environmental Conditions 6

4.3 Embryology Laboratory Equipment 7

4.4 Requirement For ART Operation Theatre And Basic Equipment 8

4.5 Preparation Prior To Procedure 11

4.6 Procedure For Collection And Handling Of Gametes 11

4.7 Assuring Quality Of Examination Procedures 13

4.8 Procedure For Storage, Transfer And Disposal Of Gametes Or 14

Embryos

4.9 Reporting Of Results 15

5. Ethics 15

6. Layout Plan For ART Laboratory 16

7. Standards For ART Facility Working Committee 17 - 18

8. Acknowledgement 19

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 FOREWORD

Assisted Reproductive Technology (ART) is a fast growing field in the

medical world. In a short period of time since the 1980s, it has developed
from the basic in-vitro fertilization (IVF) using male and female gametes from
natural cycles to intracytoplasmic sperm injection (ICSI) following stimulated
cycles to achieve a pregnancy.

Malaysia is still lagging behind in this field, with the service available only in
the big cities. However, since 1995 the Ministry of Health has taken the
initiative to train more specialists in the field of Reproductive Medicine. This
will inevitably lead to the establishment of more fertility centres in both the
government and private sectors in future.

As such, there is a need for proper guidelines in the setting up of ART

centres so that minimum standards are met. These guidelines includes the
minimum standards required for clinical and laboratory practice. A
committee comprising of infertility specialists, embryologists and officials
from the government agencies, universities, Family Planning Board and the
private sector was established to draw up this guideline. It is envisaged that
this guideline would be useful for both clinicians and embryologists in the
establishment of fertility centres and provision of related services. It would
also serve as a useful guide for scientific personnel and clinicians in
maintaining a high standard of practice, thereby ensuring the safety of
couples undergoing treatment and their embryos.

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 The cost of fertility treatment in Malaysia is still low compared to that of our
neighbouring countries. This should make fertility treatment in Malaysia
very attractive, thus promoting Medical Tourism as proposed by our Prime
Minister. These standards will ensure that a high quality service in ART will
be readily available to infertile couples in this country. In view of this, ethical
and good clinical practices must always be upheld and maintained by all
clinicians and scientific personnel involved in providing these services.

DATO SRI DR HASAN BIN ABDUL RAHMAN

Director-General of Health, Malaysia

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 STANDARDS FOR ASSISTED REPRODUCTIVE TECHNOLOGY (ART)
FACILITY - EMBRYOLOGY LABORATORY AND OPERATION THEATRE

1. Introduction

1.1 This document describes the minimum standards required for

any ART facility operating in Malaysia.

1.2 This document shall be read in conjunction with MS ISO 15189

Medical Laboratories.

2. Scope Of ART Facility For Accreditation

The areas for which the scope of services that will be offered for
accreditation purposes of the ART facility are as listed below:

2.1 Embriology laboratory

2.1.1 Semen Analysis (recognized standards e.g. WHO)

2.1.2 Sperm preparation (Fresh sample/frozen sample/
MESA/PESA/TESE/TESA/Open Biopsy)
2.1.3 Sperm cryopreservation
2.1.4 In Vitro Fertilization (IVF)
2.1.5 Gamete Intra Fallopian Transfer (GIFT)
2.1.6 Intra Cytoplasmic Sperm Injection (ICSI)
2.1.7 Assisted Hatching
2.1.8 Oocyte/Embryo/blastocyst cryopreservation
2.1.9 Preimplantation Genetic Diagnosis (PGD)
2.1.10 Other procedures involving manipulation of gamete,
embryo, and gonadal tissue

2.2 Operation theatre

2.2.1 Oocyte retriHval

2.2.2 Percutaneous Epididymal Sperm Aspiration (PESA)
2.2.3 Testicular Sperm Aspiration (TESA)
2.2.4 Testicular Sperm Extraction (TESE)
2.2.5 Micro Epididymal Sperm Aspiration (MESA)

3. Terms And Definitions

3.1 ART facility means any premise which is involved in treatments

or procedures that includes in vitro handling of human oocytes,
spermatozoa and embryos, for the purpose of establishing a
pregnancy, including but not limited to, in vitro fertilization and
embryo transfer, gamete intra - fallopian tube transfer, zygote
intra fallopian tube transfer, gamete and embryo donation,

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 cryopreservation and storage of gametes and embryo but does
not include intrauterine insemination.

The ART facility should include the consultation clinic,

andrology laboratory, embryology laboratory and operation
theatre.

3.2 Embryology laboratory is the area where the process of IVF and
ICSI are performed and this area should be separated from the
andrology laboratory.

3.3 Andrology laboratory is part of ART facility where semen is

analysed, processed and/or cryopreserved.

3.4 Clinical director is the person overall in-charge of the ART centre
responsible for all clinical and laboratory operational
management.

3.5 Laboratory director is the person-in-charge of the laboratory who

will be responsible for all operations, administration (including
the performance of technical procedures) and recording of test
results and for ensuring compliance with applicable regulations.
The post shall be a full time resident position.

3.6 Clinician in attendance is the authorized doctor (see Clause

4.1.3) who is the person overall in-charge of the patients fertility
treatment

3.7 Embryologist is the qualified technical person (see Clause 4.1.4)

who performs the relevant laboratory procedures for Assisted
Reproductive Technology (ART) as stated in Clause 2.

3.8 Medical Laboratory Technologist is the person assisting the

embriologist in performing semen analysis, semen preparation
and certain diagnostic tests in an ART facility.

4. Technical Requirements

4.1 Personnel (clause 5.1 of MS ISO 15189)

4.1.1 Clinical director shall be a registered medical practitioner

who is registered as such under the Medical Act 1971 [Act
50] and who holds a valid practising certificate with a
postgraduate qualification in O & G and registered as a
subspecialist in Reproductive Medicine by the National
Specialist Register.

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 4.1.2 The laboratory director shall have a minimum qualification of
Bachelor of Science Degree in a related Biomedical field with at
least two years of post qualification supervised training and a
minimum of 100 complete hands on cycles of IVF/ICSI (either as
part of the degree programme or as post-degree training).

4.1.3 The clinician in attendance shall be a registered medical

practitioner who is registered as such under the Medical Act
1971 [Act 50] and who holds a valid practising certificate with
a postgraduate qualification in O & G and registered as a
subspecialist in Reproductive Medicine by the National
Specialist Register.

4.1.4 The embryologist shall be registered under the law regulating

the allied health profession or in the absence of such law,
holds such qualification and experience as are recognised by
the Director General of Health. The embryologist shall have a
minimum qualification of Bachelor of Science Degree in a
related Biomedical field with at least one year of post
qualification supervised training and a minimum of 50
complete hands on cycles of IVF/ICSI (either as part of the
degree programme or as post-degree training).

4.1.5 A medical laboratory technologist shall be a person with at

least a Diploma in Medical Laboratory Technology or an
equivalent, recognised by the Director General of Health and at
least 6 months of supervised training in related area of the
laboratory services (either as part of the diploma programme or
as post-diploma training).

4.2 Accommodation And Environmental Conditions

As in MS ISO 15189 Clause 5.2.1 in addition:

4.2.1 The laboratory should be in a low-traffic, secure area separated

from other general laboratory activities and operating theatre.

4.2.2 Minimum floor area requirement for this embryology

laboratory is 100 square feet (9.29 sq. m) with minimun
ceiling height between 9 to 11 feet (2.74-3.35 m) to
accomodate the minimal equipments required for an
embryology laboratory which are the incubator,

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 micromanipulator, laminar flow, stereo microscope and ICSI
manipulator.

4.2.3 All workbenches should be purposed-built and of non toxic

surface. The ICSI micromanipulator should be preferably
placed on anti vibration work top.

4.2.4 Design and materials used in construction should be

compatible with a high level of cleansing and disinfection.

4.2.5 Use of toxic chemicals, radioisotopes, aerosol and pest control

substances shall not be permitted in the laboratory.

4.2.6 Use of strong smelling personal hygiene products e.g. perfume,

deodorant, hair spray, after shave lotion etc shall not be
permitted in the confines of the laboratory.

4.2.7 The paint for the laboratory should be lead free and odourless.

4.2.8 Foodstuff shall not be permitted in the laboratory area.

4.2.9 Incoming air should be ducted via ceiling mounted air

conditioning system. The air should be filtered by HEPA filters
to remove particulate matter.

4.2.10 If the laboratory and ART operation theatre are not adjacent to
each other, portable incubators should be used for
maintenance of gamete/embryo temperature at 37 C and pH
between 7.2 7.4 during transportation as required.

4.2.11 A separate area should be provided for record keeping, data

entry, computer data storage and related administrative
functions.

4.3 Embryology Laboratory Equipment

4.3.1 The minimum requirement for equipments in the embryology

laboratory equipments are the incubators and microscopes
(stereoscopic microscope) for egg collection and inverted
microscope for ICSI.

4.3.2 The embryology laboratory should have incubator(s) with

emergency power back-up and preferably alarm systems. The
alarm system should monitor both power failure and high and
low deviations from set points for temperature and percentage

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 of CO2 where applicable. Provision shall be made to access a
back-up incubator should the main incubator malfunction.

4.3.3 Stereoscopic microscope should be of minimum range of 60

times magnification and inverted microscope should be of 40-
400 times magnification for the procedure to which they are
used.

4.3.4 Warming devices and mechanisms shall be in place to ensure

proper maintenance of temperature at 37C. The pH between
7.2 7.4 for media, gametes and embryos during the various
phases of all procedures must be ensured and documented.

4.3.5 Where in-house media preparation is practiced there shall be

access to a pH meter and osmometer for media adjustment to
defined standards using appropriate calibration. All laboratory
chemicals and reagents shall be labelled to indicate date
received, date opened and shelf life where applicable.

4.3.6 All containers in contact with body fluids shall be disposable

and compatible with tissue culture standards.

4.3.7 Gas cylinders should be placed outside or in a separate room

with a backup system. Gas supplies to incubators must be of
a suitable quality with mechanisms in place to ensure
continuity of supply. Certificate of purity shall be available at
all times. Appropriate filters to be placed to ensure quality of
gas supply to incubator maintained.

4.3.8 Gamete and embryo manipulation shall be done in laminar

flow work station.

4.3.9 Written protocols shall be in place such that treatment

outcome will be minimally compromised in the event of
malfunction of essential equipment or non-availability of key
personnel.

4.3.10 All laboratory environment parameters should be documented

daily and verified.

4.4 Requirement For ART Operation Theatre And Basic Equipment

4.4.1 Minimum floor area requirement for the operation theatre is

100 square feet (9.29 sq. m) to accomodate the basic

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 equipments required for ART Operation Theatre equipment as
in 4.4.12

4.4.2  The ART Operation Theatre is preferably attached to the

Embryology Lab with access via window or door as suggested
in appendix 1.

4.4.3 The Changing Room should be a separate area and located

within the operation theatre complex.

4.4.4 Surgical light source should be made either mobile or

attached for adequate exposure.

4.4.5 The scrubbing area should be attached to the Operation

Theatre.

4.4.6 The Operation Theatre shall have a jointless ceiling with

covered ceiling lights to prevent particles from above the
ceiling having direct access to the operation theatre area.

4.4.7 Ventilation

i. The operation theatre shall be mechanically ventilated to

provide 100 percent fresh air without recirculation.

ii. The operation theatre shall be provided with a minimum

ventilation rate of twenty room volumes of air change per
hour by mechanical supply and exhaust air system. The
outdoor air intakes shall be located as far as practicable
but not less than 23 feet (7.6 m) from the exhausts of any
ventilating system, combustion equipment, medical
surgical vacuum system or plumbing vent areas which
may collect noxious fumes.

iii. The bottom of the outdoor air intake shall be located as

high as practical but not less than 3 feet (0.9 m) above the
ground level or if installed through the roof, not less than
3 feet (0.9 m) above the roof level.

4.4.8 The operation theatre temperature should be maintained at

24 - 26 C.

4.4.9 Preferably there should not be any opening that allows

sunlight into the operation theatre. However, if there are such
openings with direct exposure to sunlight, they shall be
covered with ultra violet protector.

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 4.4.10 Interior finishes

i. Heavy duty vinyl shall be used for the floor with minimum
of 4 inches (10 cm) height at the edges.

ii. Interior finishes of the operation theatre shall be smooth,

jointless and non- interrupted. It shall be able to facilitate
and withstand frequent cleaning and disinfecting.

4.4.11 The recovery area shall be adequately equipped which

includes:

i. trolleys with the capability of tilting patients  head

downwards.

ii. oxygen supply and the appliance for delivering oxygen to

the patient.

iii. adequate suction apparatus.

iv. equipment and drugs for resuscitation.

v. accessibility to electrocardiogram and pulse oxymeter .

vi. accessibility to specialised equipment as necessary for the

continuing care of the patient.

4.4.12 Basic equipment requirement for ART operation theatre:

i. A 2-D ultrasound machine for transvaginal scan and

transabdominal scan with availability of a needle biopsy
guideline on TV monitor for the purpose of
transvaginal oocyte retrieval.

ii. Oocyte retrieval system with vacuum system and tube

warmer attached to it to maintain the tubes at 37C
throughout the procedure.

iii. Patient monitoring must be present pulse oxymeter for

PaO2 and continuous blood pressure (BP) and pulse rate
(PR) monitoring.

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 iv. Resuscitation trolley with adequate drugs and equipment
to treat any medical emergencies that may be faced in the
course of managing ART patients.

v. Adjustable operation theatre table with suitable surgical

stool for oocyte retrieval and embryo transfer.

4.5 Preparation Prior To Procedure

4.5.1 Preparation of patients

i. A consent form shall be signed by the patient and a copy

kept in the patients record for any ART procedures that
the patient and/or couple have to undergo.

ii. A separate consent form is to be signed by both partners

for cryopreservation procedures and subsequent use of the
surplus embryos and gametes.

4.5.2 Laboratory safety and infection control

i. Couples undergoing treatment shall be subjected to

appropriate infectious disease screening and quarantine to
ensure the gametes and embryos are free from infectious
diseases. The minimum diseases to be screened for are
HIV1, HIV 2, Hepatitis B and Syphilis. HIV positive
patients are referred to the appropriate medical specialist
for further treatment. Syphilis carriers are treated with the
relevant antibiotic prior to proceeding with ART.

ii. HIV and Hepatitis carriers shall be listed as the last case
and the operating theatre shall subsequently be closed
and cleansed using the standard hospital procedure for
such cases. The laboratory personnel should handle all
gametes from such patients using the standard double-
gloving technique in addition to the aseptic techniques.
The gametes shall be incubated separately from those of
other patients.

4.6. Procedure For Collection And Handling Of Gametes

4.6.1 Oocyte retrieval should be performed under standard sterile

technique as applicable in an operation theatre. Subsequent
handling of gametes shall be undertaken using aseptic
techniques (e.g. with proper gowning and wearing of mask,
gloves and theatre cap).

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 4.6.2 The quality assurance system should be such as to detect
clerical, transcriptional and analytical errors. Identity of
gametes and embryos must be double checked at critical
steps. Double checking should be indicated in the records by
signatures and identifications of the personnel involved. There
shall be adequate documentation to indicate this process.

4.6.3 Biosecurity

i. To protect the security of gametes, only authorised

personnel are allowed to enter the laboratory or storage
area. Security measures shall be in place to prevent
unauthorised entry.

ii. All containers and storage for gametes shall be properly

labelled and recorded.

iii. All disposables for handling gametes shall be used only

once.

iv. All storage containers shall be locked and stored in secure

facilities.

4.6.4 The procedure should be performed at least under sedation as

a minimum to conform to the standard requirements in
Private Healthcare Facilities and Services (Private Hospitals
and Other Healthcare Facilities) Regulations 2006.

4.6.5 Person allowed to administer anaesthesia:

i. General or regional anaesthesia should be administered

only by an anaesthetist or a registered medical
practitioner, on condition that he has experience
in anaesthesiology and is under supervision of an
anaesthetist.

ii. A registered medical practitioner may administer local

anaesthesia/sedation in treatment and procedures
requiring such anaesthesia/sedation.

4.6.6 Administration of anaesthesia:

4.6.6.1 Before any anaesthesia is administered to a patient,

there shall be entered on the medical record of the
patient;

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 i. history of the present illness

ii. the results of appropriate laboratory

investigations essential to the proper
assessment of the patients physical condition

iii. the findings on physical examination

4.6.6.2 Before anaesthesia is administered to the patient,

the person administering the anaesthesia shall;

i. take a medical history and make a physical

examination of the patient, sufficient to enable
him/her to evaluate the physical condition of
the patient and to choose a suitable
anaesthesia for the patient;

and

ii. enter on the anaesthetic record, and sign, a

statement of data relevant to administering the
anaesthesia from the patient history,
laboratory findings and physical examination.

4.6.7 The procedure shall be performed by an O&G specialist

trained in ART.

4.6.8 The nursing services shall be under the supervision of a

registered nurse with training and experience in operation
theatre nursing.

4.7 Assuring Quality Of Examination Procedures

4.7.1 Incubator performance shall be monitored daily for

temperature and gas composition. Calibration shall be
performed at regular intervals.

4.7.2
2 Water purification systems where applicable shall be
maintained to the manufacturer's specifications for tissue-
culture quality and performance monitored and recorded on a
daily basis. Screening for pyrogens is essential.

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 4.7.3 In-house media, where applicable, shall be of an accepted
preparation method to ensure suitability for use with human
gametes or embryos.

4.7.4 Data from the laboratory shall be regularly analysed to

determine that the following minimum criteria are achieved:

i. fertilisation rate of at least 60% in couples without male

factor infertility.

ii. fertilisation rate of at least 60% following ICSI.

iii. A minimum pregnancy rate of 25% per embryo transfer

for IVF/ICSI treatment.

4.8 Procedure For Storage, Transfer And Disposal Of Gametes Or

Embryos

4.8.1 Facilities shall be made available for cryopreservation of

remaining viable embryos either in the same laboratory or
other associated laboratory.

4.8.2 The following protocol shall be adhered to, for transfer of

gametes or embryos from one ART facility to another:

i. Patients are required to complete the neccessary

documents to authorize the transfer.

ii. Once the above requirement have been completed, staff

will contact the receiving facility to arrange the transfer.

iii. The facility should label each package containing

gametes and embryos with the identity of the patient.

iv. The embryos and gametes must be held in a

temperature controlled container (minimum
temperature should be at least -130C) in order to
preserve them in frozen state.

4.8.3 Safe disposal of tissue samples no longer required shall be

carried out in accordance with existing regulations or
recommendations for biohazard material.

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 4.9 Reporting Of Results

4.9.1 All laboratory issues concerning patients treatment and the

source and fate of all gametes and embryos shall be
documented.

4.9.2 All results and reports pertaining to embryology shall be

validated by the embryologist.

4.9.3 A report shall be prepared and made available to the Ministry

of Health as requested. The report should include data
such as:

i. number of all the various ART cycles (In Vitro

Fertilization, Intra Cytoplasmic Sperm Injection and
Frozen Embryo Transfer).

ii. fertilization rates for IVF and ICSI using ejaculated

spermatozoa.

iii. fertilization rate for ICSI using aspirated sperm from

PESA, TESA, TESE, MESA.
iv. cleavage rate for 4.9.3.ii and 4.9.3.iii where applicable
in the centre.

v. frozen embryo thaw survival rate.

vi. pregnancy rates from fresh and frozen-thaw cycles.

vii. cancellation rate with reasons.

5. Ethics

Confidentiality relating to patient information shall be maintained at

all times.

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 Appendix 1

6. Layout Plan For ART Laboratory 

Scrub 
Freezing room

Embryology Lab  OT


Andrology Lab
Hatch



Hatch


Gas Room hanging Masturbatorium
Room 
(Sound Proof)


Store Room
Administrative
Office 
Recovery Room


Doctors Room



Main Entrance

Doors

16

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 7. Standards For Assisted Reproductive Technology (ART)
Facility Working Committee

1. Prof. Dr. Zainul Rashid Mohamad Razi (Chairman)

MD(UKM), MOG(UKM), MRCOG(London), AM (Malaysia)
DM(Nottingham), FICS(USA), FRCOG(London)
Dean of Postgraduate
Faculty of Medicine
UKM Medical Centre

2. Y. Bhg Dato Dr Mukudan Krishnan

MBBS(UM), FRCOG(London)
Senior Consultant and Head of O&G Services
Hospital Raja Permaisuri Bainun, Ipoh

3. Dr. Ahmad Razid Bin Salleh

MBBS(UM),MPH(UKM)
Director
Medical Practise Division
Ministry of Health, Malaysia

4. Dr. Haji Mohamad Farouk Bin Abdullah

MBBS (Mal), FRCOG (London), CRM (Malaysia)
Senior Consultant & Head of O&G Department
Hospital Tengku Ampuan Rahimah, Klang

5. Dato' Dr Prashant Nadkarni

MBBS(Mal) FRCOG(London)
Consultant Gynaecologist & Fertility Specialist
KL Fertility Center

6. Dr. Noor Haliza binti Yussoff

M.D (UKM), M.Med (O&G), Fellow Reprodutive Medicine
Senior O&G Consultant
Hospital Kuala Lumpur

7. Dr J. Ravichandran Jeganathan

MD. M.MED (O&G), Fellow Maternal Fetal Medicine (UK)
Senior Consultant and Head of O&G Department
Hospital Sultanah Aminah, Johor Bahru
And Advisor for O&G Services(MOH)

8. Dr. Rosliah Harun

BSc (Hons) Microbiology (Wales, UK); MSc in Medical Sciences (ART)
(Nottingham, UK); PhD Stem Cells (Sheffield, UK)
Embryologist
National Population and Family Development Board

9. Dr. Ruhaima Ramli

BSc. (Zoology), M.PHIL (Biotechnology Of Animal ReproductioQ
Embryologist
Prince Court Medical Centre
17

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 10. Dr Komathy Thiagarajan
M.D. (UKM)
Medical Officer
Human Reproduction Division
National Population and Family Development Board

11. Dr Noor Aziah Zainal Abidin

MD (UKM), MPH (Hospital Management) (Mal)
Senior Principal Assistant Director
Medical Development Division
Ministry of Health

12. Dr Arpah Binti Ali

MD (UKM)
Senior Principal Assistant Director
Medical Development Division
Ministry of Health

18

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 8. Acknowledgement

The Working Committee on Standards For Assisted Reproductive Technology

(ART) Laboratories, would like to express their gratitute and appreciation to
the following for their support and invaluable input and feedback, without
which the publication for this document would not have been possible.

1. Department Of Standard Malaysia

Ministry of Science, Technology and Innovation

2. Datuk Dr. Noor Hisham Bin Abdullah

Deputy Director General of Health (Medical)
Ministry of Health

3. Dato Dr. Azmi Bin Shapie

Director
Medical Development Division
Ministry of Health, Malaysia

19

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 Kementerian Kesihatan Malaysia
Bahagian Perkembangan Perubatan
Kementerian Kesihatan Malaysia
Blok E1, Parcel E
Pusat Pentadbiran Kerajaan Malaysia
62590 Putrajaya
MALAYSIA
ISBN 978-983-44999-8-3

9 789834 499983

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