INTRODUCTION TO HALAL MEDICAL

DEVICE

9TH Halal Certification Bodies Convention 2018

April 2018
 INTRODUCTION

• Understanding medical devices and its regulatory requirements

• Understand WHY the need for a standard for halal medical devices
• -Understand the role of each of the stakeholders in developing the halal medical
devices
• -Understand how the requirements of the standard in the certification of halal
medical devices
• -Understand the certification and regulatory process governing halal medical
devices.
• Way forward
Definition
What is a medical device?
“Medical device” is any instrument, apparatus, implement, machine,
appliance, implant, in vitro reagent or calibrator, software, material or other
similar or related article:
a) intended by the manufacturer to be used, alone or in combination, for
human beings for one or more of the specific purposes of:
 diagnosis, prevention, monitoring, treatment or alleviation of disease;
 compensation for an injury;
 investigation, replacement, modification, or support of the anatomy or of a
physiological process;
 supporting or sustaining life;
 control of conception;
 disinfection of medical devices;
 providing information for medical or diagnostic purposes by means of in vitro
examination of specimens derived from the human body;
and
b) which does not achieve its primary intended action in or on the human
body by pharmacological, immunological or metabolic means, but
which may be assisted in its intended function by such means
Medical Devices Bureau
MINISTRY OF HEALTH MALAYSIA
 Malaysia
Exports of Medical Devices

7% Others
5% Orthopedic implants
11% Electro mechanical MD
Gloves Medical 12% Contraceptives
RM RM Devices 12% Catheters, syringes, needles &
sutures
9.4 2.3 (Excluding 13%2.3
Ophthalmic
Billion Billion
Gloves) 12% Radiation devices

28% Reusable instruments

Total Exports in 2011: RM11.7 Billion

Source: Malaysia Statistics Department, MITI, MIDA, PEMANDU

Medical Device Industry Ecosystem in Malaysia
Materials: Rubber, Plastics, Steel, Electronics, etc.

Surgical Instruments, Healthcare

Consumables
Implants & Clinical Devices Equipment

Latex
Technology Metal Machining Electronics Furniture
Plastic
Glove, Contraceptives, Pacemaker, Orthopedics, Radiation equipment,
Products Catheters, woundcare, Surgical instrument Life Science Instrument,
Orthalmology, IVD, SUD Electrodes, Hospital beds

Companies

Supporting Infrastructure
Biocompatibility Industry Education
Sterilization Packaging Certification Regulatory
And Clinical Trial Group Training

UKM, UM, USM, UKM, Medical

UniMap, PSDC, Device
Info
Medsociate, Act 2012
Kinetics
Neville Clarke
The regulation of Medical Devices in Malaysia
• Integral part of the health care delivery system
• Important in terms of safety and effectiveness of the medical device
• It is well regulated through its regulatory framework
• Under the current laws, (Act 737) Malaysia has in place a national regulatory
system designed to protect public health and ensure safety and
performance
• Thus the system ensures that the medical device its safety and performance is
maintained throughout its lifespan
• The regulatory framework is well harmonised with international forums
• Current national law in Malaysia requires each establishment to be licenced and
the medical device registered
Medical Device Lifecycle – What are
the Regulatory Activities?
 Overview of The Regulatory System
PRE-MARKET PLACEMENT ON-MARKET POST-MARKET

MEDICAL DEVICES MDA allows - SURVEILLANCE & VIGILANCE

PRE-MARKET REVIEW REGISTRATION • registered Establishments shall-
Manufacturers of medical • Manufacturers (or LARs) medical • monitor safety & performance of
devices shall - apply for register medical devices to be their products
• ensure their products devices & establishment placed into the • carry out post-market
conform to EPSP license to manufacture market obligations, eg user training,
• ensure their products are • licensed complaint handling, FSCA,
manufactured in accordance DISTRIBUTORS establishments recall
with GMP LICENSING to do their
• collect evidence of Distributors shall - business USAGE & MAINTENANCE
conformity • ensure compliance to • Users shall use, maintain &
GDP & advertising MEDICAL dispose off medical devices
requirements DEVICES WILL appropriately
CAB verifies evidence of • apply for establishment BE MADE • Users shall apply for permit to
conformity license to distribute AVAILABLE ON use/operate designated medical
medical devices THE MARKET devices

MDA monitors compliance to requirements & takes appropriate

actions in accordance with the provisions of the law
 MEDICAL DEVICES LIFE CYCLE IN
HEALTHCARE FACILITIES

Replacement Planning,
User
Establishments Devices Device
requirements
licenced registered Assessment-HTA
Disposal Procurement

MDA register
devices and license Maintenance Installation/Testing &
establisments Commissioning/Acceptance

Use Devices
Inventory of Hosp

Field Safety
Corrective
Actions
Training
Incident
reporting
Why the need for Halal Medical Devices Standard

• Demand in proposals for specific new products

• Changing of classification of medical products
• For certification purposes by the halal certification body

Hence there is a need for a standard on Halal to be

developed for medical devices
Use of Halal Standard on Medical Devices
• New Proposals for development of Malaysian Standard:- as an example
on Halal Synthetic Bone Graft and other Halal Medical Devices received
prior to 2017.
• Pharmaceutical products that were reclassified as Medical devices
could not continue to be certified halal under MS 2424 and this caused
confusion in consumers.
• Enables certification bodies to certify Halal for medical devices
 Objectives of the Standard

• Is to assist industry in obtaining halal certification, not to mandate

• Develop a standard that is implementable according to the Syariah
laws
• No testing of products but built into the entire system
 Main Benefits of the Standard
• Enables pharmaceutical products that were reclassified as medical devices
to be certified halal under the new scheme to be developed by JAKIM
• The Standard is voluntary
• Safety and performance is assured as the products
need to be registered and the establishments licensed
by MDA as the main requirement of all medical devices
is its safety and performance as such, all medical
device has to comply with the Medical Device Act 2012
(Act 737) before it can be certified halal.
FRAMEWORK OF HALAL MEDICAL DEVICE CERTIFICATION

Department
of
Standards •Owner of Malaysian
Malaysia Standards

Medical
•Regulates Medical
Device
Authority Devices

•Halal competent authority (together with

various State Islamic Religious Councils)
JAKIM •Determines scope of halal certification
through offering of schemes
•Certifies and monitors halal certifications
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 SCOPE OF CERTIFICATION

• To be determined by JAKIM following internal

procedures
• Priority to be given to medical devices that were
reclassified from pharmaceuticals
 MS ON HALAL MEDICAL DEVICE:
CONTENTS
• Committee representation Requirements
 Quality management
• Foreword  Management responsibility
 Halal Assurance Management System
• Introduction  Fundamentals for halal medical devices
• Scope  Halal quality control
 Personnel and responsibility
• Normative references  Training
 Personal hygiene
• Terms and definitions  Manufacturing premise and equipment
• Compliance  Manufacturing and storage areas
 Quality control areas
• Halal certificates  Ancillary areas
 Documentation
• Halal certification logo  Manufacturing
• Annex A Method of washing and  Materials
 Packaging, labelling and advertising
sertu according to Shariah law for  Outsourced activities
najs al-mughallazah  Self-inspection 16
 Legal requirements
 Introduction
• to meet the challenges of the growing demand for halal products and
services
• to complement the halal ecosystem
• based on the concept of halal built-in
• Not tested into products, but built-in into the entire system
• Obtaining halal certification is a business strategy and is seen
as a value added element.

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 SCOPE OF THE STANDARD

This Malaysian Standard specifies the requirements in the

manufacturing and handling of particular medical devices as
specified by the halal competent authority for the purpose of
halal certification.

SCOPE OF CERTIFICATION SHALL BE DETERMINED BY JAKIM

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 3. TERMS AND DEFINITION
3.1 competent authority

 The competent authority for medical device is the Medical Device

Authority established under Medical Device Authority Act 2012 (Act
738)

3.4 halal competent authority

 In Malaysia, the halal competent authorities are JAKIM and the various
State Islamic Religious Councils
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 4. REQUIREMENTS

4.1 Quality management

The manufacturer shall ensure that the medical device

for halal certification are manufactured in accordance
with ISO 13485.

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 4.2 MANAGEMENT RESPONSIBILITY
The management shall:
 ensure that the halal assurance management system shall be comprehensively designed,
developed, implemented, monitored and maintained to incorporate application of halal and
ISO 13485.
 appoint muslim halal executive and establish an internal halal committee who is responsible
to ensure the effectiveness in implementation of internal halal control system.
 provide training regularly to relevant personnel on the halal principles and its application.
 ensure that sufficient resources (i.e. manpower, facility, financial and infrastructure) are
provided.
 ensure all related activities for manufacturing and handling of halal medical devices are
properly recorded. All documents and records shall be maintained and traceable.
 allow the workers to fulfill the obligation of their religious practice.
 ensure that the participation and commitment by staffs in various departments and at all
levels within the company, the company’s suppliers and distributors. 21
 3.8 INTERNAL HALAL COMMITTEE (IHC)

3.8 A committee established by the organisations to be

responsible for developing, monitoring and controlling the halal
assurance management system to ensure its effectiveness.

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 4.3 HALAL ASSURANCE MANAGEMENT SYSTEM
The halal assurance management system shall be appropriate for the
manufacturing of halal medical devices and shall be ensured that:

a) the medical devices are designed and developed to comply with the
requirements of halal and ISO 13485;

b) the production and control operations are clearly specified and in

compliance with ISO 13485;

c) the processing line shall be operated for halal medical devices only and in
the case of converting the processing line which contained or
contaminated with najs al-mughallazah to a halal production line then the
sertu method by Shariah law shall be required. 23
 4.4 FUNDAMENTALS FOR HALAL MEDICAL DEVICES
 The requirements described in the ISO 13485 are integral part of the
standard and shall be referred to for the recognition for halal medical
devices.

 The main control point is on the source of materials, equipment and

utilities that is in direct contact with the products

 All records shall be maintained. Any significant deviations shall be fully

investigated and documented.

 All records of manufacturing including distribution which enable the

complete history of a batch to be traced are retained and maintained in a
comprehensible, legible and accessible form. 24
 FUNDAMENTALS FOR HALAL MEDICAL DEVICES
All materials are clearly defined with evidence of complying with
Shariah law and fatwa.

All necessary facilities and resources for halal compliance are

provided including availability of:
i) qualified and competent personnel;
ii) adequate premises, spaces, utilities and services;
iii) dedicated equipment and production lines;
iv) materials, containers and labels approved by IHC;
v) procedures and instructions approved by IHC; and
vi) dedicated storage and transport
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 FUNDAMENTALS FOR HALAL MEDICAL DEVICES
 The distribution of the products minimises any risk to their halal
integrity.
 A post-market halal surveillance system is established and
maintained.
 Any complaint about marketed products are examined and the
causes of halal non-compliance investigated. The appropriate
measures in respect of the non-compliance are taken and shall
prevent re-occurrence.

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 4.5 HALAL QUALITY CONTROL
Halal quality control is to ensure all materials used in manufacturing
and laboratory are halal compliant.

The purchase, handling and sourcing of chemicals, reagents, apparatus,

equipment and other items required for sampling and testing shall not
be made from any source that is decreed as non-halal by Shariah law
and fatwa.

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 4.6 PERSONNEL AND RESPONSIBILITY
4.7 TRAINING
 The organisation shall ensure that there are sufficient qualified and competent personnel available to
establish and maintain a satisfactory halal assurance management system.

 All personnel shall be aware of the principles of halal and receive initial and continual training relevant to
their needs.

 training programmes shall be developed which include halal related training to ensure personnel involved
in the operation are trained and/or instructed to a level appropriate to the operations to be performed.

 Continual training shall be given, and the practical effectiveness shall be periodically assessed. The training
programmes shall be available and approved by the internal halal committee. All training records shall be
maintained.
 4.8 PERSONAL HYGIENE
 Strict personal hygiene is an integral requirement for halal and
shall be adequately addressed, and in compliance with ISO 13485.

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 4.9 MANUFACTURING PREMISE AND EQUIPMENT
 manufacturing premise shall be situated in an environment which, when
considered together with measures to protect the manufacturing process,
presents no risk of causing contamination of non-halal materials or products.
The layout and design shall conform to the requirements of the ISO 13485.
 The manufacturing premise shall be effectively separated and well insulated
from pig, dog and other animal farm activities and others, in order to prevent
cross contamination through air, water, sewerage, personnel and equipment.
 The manufacturing premise shall not have any presence of non-conformance
items such as non halal food and beverages.
 The manufacturing facility shall not have any tool and elements of religious
worship. 30
 MANUFACTURING PREMISE AND EQUIPMENT
 Repetition in converting the production line to najs al-
mughallazah line and back to halal line, shall not be
permitted.
 Pets and other animals shall be prohibited from entering the
manufacturing premises.

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 4.10 MANUFACTURING AND STORAGE AREAS
4.12 QUALITY CONTROL AREAS
4.13 ANCILLARY AREAS
 There shall be dedicated and self-contained facilities available for the
manufacturing and storage of halal medical devices to avoid the risk of non-
halal contamination.
 When handling and conducting quality control activities in the manufacturing
area, the operations for control laboratories shall take precaution to prevent
contamination on production line which may cause product to be non-halal.
 Muslim praying area shall be provided and appropriately located.
 Animal houses shall be well isolated from other areas, with separate entrance
(animal access) and air handling facilities.
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 4.11 TRANSPORTATION
Transportation vehicles shall be dedicated and
appropriate to the type of the halal medical device and
satisfy hygiene and sanitation condition.

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 4.14 Documentation
The halal assurance management system shall be documented
including evidence of materials origin and shall be approved, signed
and dated by the internal halal committee. The documents required
for the materials shall include but are not limited to:

a) halal certificates from recognised certification bodies;

b) product data sheet which contains complete description on the
source or origin of materials and method of processing; and
c) manufacturing formula and processing instructions.
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 4.15 MANUFACTURING
4.16 MATERIALS
 The manufacturing operations shall follow clearly defined
documented procedures and comply with halal principles.
 All materials used in manufacturing of medical devices shall comply
with halal requirements. Materials may be from synthetically or
naturally derived sources or genetically modified organisms (GMO).
 All najs are prohibited.

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 4.16.1 SYNTHETIC MATERIALS
4.16.2 NATURAL MATERIALS
4.16 3 PLANTS
Synthetic materials
• The sources and processing of synthesized materials shall comply with halal requirements. The
usage of synthetic ethanol is permissible.

Natural materials
• The usage of all natural materials such as plants, animals, minerals, microorganisms, natural-
occuring chemicals and genetically modified organisms (GMO) may be used in medical devices
as approved by the competent authority.
• Natural materials that are poisonous, intoxicating or hazardous for health may also be used for
medical purposes as approved by the competent authority.
Plants
• All types of plants and plant products and their derivatives are halal except those prohibited
by the competent authority.
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 4.16.4 ANIMALS – LAND ANIMALS
All land animals are halal except for the following:
• animals that are not slaughtered according to Shariah law;
• najs al-mughallazah animal, i.e. pigs, dogs and their derivatives;
• animals with long pointed teeth or tusks which are used to kill prey such as tigers,
bears, elephants, cats, monkeys, etc.;
• predator birds such as eagles, owls and etc.;
• pests and/or poisonous animals such as rats, cockroaches, centipedes, scorpions,
snakes, wasps and other similar animals;
• animals that are forbidden to be killed in Islam such as bees (al-nahlah), woodpeckers
(hud-hud), etc.;
• creatures that are considered repulsive such as lice, flies, etc.;
• farmed halal animals which are intentionally and continually fed with najs;
• other animals forbidden to be eaten in accordance with Shariah law and fatwa; and
• other animals that are prohibited by the competent authority.
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 4.16.4 ANIMALS – AQUATIC ANIMALS
• All aquatic animals are halal except
– those that are poisonous, intoxicating or hazardous to health;
– animals that live both on land and water such as crocodiles,
turtles and frogs;
– animals which live in najs or intentionally and/or continually fed
with najs; and
– Other aquatics animals forbidden to be eaten in accordance with
Shariah law and fatwa.

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 4.16.5 MICRO-ORGANISMS
4.16.6 NATURAL-OCCURING CHEMICALS
4.16.7 GMO
Micro-organisms
• Microscopic organism ranging from 10-6µ to 10-9µ of medical interest include
bacteria, rickettsiae, viruses, fungi and protozoa. All micro-organisms are halal
except those prohibited by the competent authority.

Natural-occurring chemicals
• All natural-occuring chemicals are halal except those prohibited by the competent
authority.

Genetically modified organisms (GMO)

• Products and/or by-products of genetically modified organisms (GMOs) or
ingredients made by the use of genetic material of animals that are decreed as halal
by Shariah law.
 4.17 PACKAGING, LABELLING
Halal medical devices shall be suitably packed. Packaging materials shall be halal and fulfill the following
requirements:
a) the packaging materials shall not be made from any raw materials that are decreed as najs by Shariah law
and fatwa;
b) it is not prepared, processed or manufactured using equipment that is contaminated with najs as decreed by
Shariah law and fatwa;
c) during its preparation, processing, storage or transportation, it shall be segregated from any other materials
that does not meet the requirements stated in item a) or b);
d) the packaging material does not have any toxic effect on the halal medical devices;
e) packaging design, sign, symbol, logo, name and picture shall not be misleading and/or contravening the
principles of Shariah law and fatwa;
f) packing process shall be carried out in a clean and hygienic manner and in sound sanitary conditions; and
g) labelling material used in contact with primary packaging of halal medical devices shall be non-hazardous and
halal.
Packaging shall not display indecent elements and contravene with the principles of Shariah law and fatwa as well
as Medical Devices 2012 (Act 737) and its subsidiary regulations.
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 4.18 OUTSOURCED ACTIVITIES
4.19 INTERNAL AUDIT
4.20 LEGAL REQUIREMENTS
• Outsourced activities shall be correctly defined, agreed and controlled in order to avoid
misunderstandings. Outsource activities shall result in a product or work of satisfactory
quality and that is decreed as halal by Shariah law and fatwa. There shall be a written
contract between the contract giver and the contract acceptor which clearly establishes
the duties of each party which include complying with the halal requirements.

• Internal audit shall be conducted annually in order to monitor the implementation and
compliance with halal and ISO 13485 and to propose necessary corrective measures.

• Halal medical devices shall comply with legislation including other relevant requirements
currently in force in Malaysia and/or producing country.
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 5 COMPLIANCE

• This standard shall be used to demonstrate compliance

towards certification of halal medical devices by the halal
competent authority.

• The procedure and requirements for certification will be as

specified by the halal competent authority.

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 6 HALAL CERTIFICATES
7 HALAL CERTIFICATION LOGO
• The halal certificates shall be issued by the halal competent
authority in Malaysia.

• Each halal medical device, upon approval by the competent

authorities in Malaysia, shall be marked with the halal certification
logo of that authority provided the product conforms to the
requirements of this standard.

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Thank
You