Medical Device Authority

Malaysia

22th November 2013

Malaysian Market

• Malaysia currently imports around 95% of the medical device for its consumption especially on active devices

• The medical devices industry :-

– highly diversified industry that produces a broad range of products and equipment ranging from medical gloves, implantable devices, orthopaedic devices and dialysers to diagnostic imaging equipment and minimal invasive surgical equipment and other devices which can be used for medical, surgical, dental, optical and general health purpose.

The Industry in Malaysia

• 190 small to large players in the country –

(manufacturing, distribution, sales )

• Export revenues of RM 11.7 Billion in 2011

• Export CAGR of 10 % per annum from 2000 – 2011

• Dominated by MNCs and local latex glove manufacturers

Source: AMMI

9.4 2.32.3

28%

12%

13%

12%

12%

11%5%7%

Reusable instruments

Radiation devices

Opthalmic

Catheters, syringes, needles &

sutures

Contraceptives

Electro mechanical MDOrthopedic implants

Others

Malaysia

Exports of Medical Devices

RM

Billion

RM

Billion

GlovesMedical

Devices

(Excluding

Gloves)

Source: Malaysia Statistics Department, MITI, MIDA, PEMANDU

Total Exports in 2011: RM11.7 Billion

ConsumablesSurgical Instruments,

Implants & Clinical Devices

Healthcare

Equipment

TechnologyLatex

PlasticMetal Machining Implants IVDs, others

Products

Companies

Supporting Infrastructure

Sterilization CertificationPackagingBiocompatibility

And Clinical Trial

Materials: Rubber, Plastics, Steel, Electronics, etc.

Industry

Group

Education

TrainingRegulatory

Glove, Contraceptives,

Catheters, woundcare,

Orthalmology,

Pacemaker, Orthopedics,

Surgical instrument

Radiation equipment, IVDs,

Life Science Instrument,

Electrodes, Hospital beds

UKM, UM, USM, UKM,

UniMap, PSDC,

Medsociate,

Neville Clarke

Medical

Device

Act 2012

Medical Device Industry Ecosystem in Malaysia

Info

Kinetics

World Health Organization guidance

“Governments need to put in place policies that will

address all elements related to medical devices,

ranging from access to high quality, affordable

products, through to their safe and appropriate use

and disposal. …

Policies will be unsuccessful unless they are

translated into national regulations that are enforced

by legislation and correlating sanctions, and that form

an integral part of the overall national health system.”

Source: Medical device regulations: Global overview and guiding principles; World Health Organization, Geneva; 2003

(At: http://www.who.int/medical_devices/publications/en/MD_Regulations.pdf )

Philippines

Mexico

Australia

CONCEPTUAL QUALITATIVE OVERVIEW OF CURRENT

NATIONAL MEDICAL DEVICE REGULATORY SYSTEMS - TRENDS

low

hig

h

highlow

Ha

rmo

niz

ati

on

(G

HT

F /

MD

PW

G)

Comprehensiveness

SingaporeEU, EFTA

CanadaArab Saudi

Chinese Taipei

Japan

USAKorea

Thailand

ChinaBrazil

ColumbiaArgentina

Pakistan

New Zealand

Bangladesh

India South AfricaNOTES:

• Position in clusters not necessarily

significant

• Subjective assessment of many variables

• Variables not weighted

• Not all countries that regulate medical

devices shown

• Some countries moving faster than others

and with different paths

Brunei

Cambodia

LaosVietnam

Indonesia

Myanmar

Malaysia

Reference: M. Gropp; Institute of Medicine, Washington, D.C; 2-3 March 2011

Background

�Policy direction: Cabinet decision 2005

�Policy: Regulatory framework for the control of medical devices in Malaysia– Based on & harmonized with global regulatory

model

– Using the WHO model, in-line with WTO agreement

– Adoption of ASEAN AMDD and

– Adoption of major trading partners eg USA, Japan, Canada, EU and Australia regulatory requirements

Aims of the Regulatory Framework

� Conducive environment

for medical devices

manufacturing

� Facilitate trade and export

� Promote health tourism

Ensure public health

and safety Facilitate trade and

industry� Assurance for safety and

performance

� Timely access for beneficial medical technologies

� Prevent dumping ground for unsafe and defective medical devices

� Third party service for maintenance

Harmonised Regulatory Framework

• Definition of Medical Device

• Classification of Medical Device

• Pre-Market Requirements such as Essential Principles of Safety and Performance (6 Principles and 11 Performance)

• Requirements for placement on market such as labelling & advertisement

• Post Market requirements such Vigilance and Surveillance

Medical Device

•Diagnostic

•Therapeutic

Implantable

Medical Device

Active Others

(Non-Active)

Non-Invasive Invasive

Class A Class B Class C Class D

Engineering Services Division Ministry of Health

Medical DevicesMedical Devices

Chief Executive, officers, servants

MEDICAL DEVICE AUTHORITY

MINISTER OF HEALTH

MEDICAL DEVICE AUTHORITY

http://www.mdb.gov.myucture of Medical Device

Regulatory System

MEDICAL DEVICE REGULATORY SYSTEM

MEDICAL DEVICE AUTHORITY ACT 2012

(ACT 738)

MEDICAL DEVICE ACT 2012 (ACT 737)

CABs

Establishments•Manufacturers•LARs•Distributors•Exporters

Users

.. gives powers to

…

.. gives powers to

…

USAGE & MAINTENANCE

• Users shall use, maintain &

dispose off medical devices

appropriately

• Users shall apply for permit to

use/operate designated medical

devices

USAGE & MAINTENANCE

• Users shall use, maintain &

dispose off medical devices

appropriately

• Users shall apply for permit to

use/operate designated medical

devices

SURVEILLANCE & VIGILANCE

Establishments shall-

• monitor safety & performance of

their products

• carry out post-market

obligations, eg user training,

complaint handling, FSCA,

recall

MDA will allow:-

• registered medical

devices to be

placed into the

market

• licensed establishments

to do their

business

ONLY THEN

MEDICAL

DEVICES WILL

BE MADE

AVAILABLE ON

THE MARKET

MDA will allow:-

• registered medical

devices to be

placed into the

market

• licensed establishments

to do their

business

ONLY THEN

MEDICAL

DEVICES WILL

BE MADE

AVAILABLE ON

THE MARKET

Overview of The Regulatory System

PRE-MARKET REVIEW

All Manufacturers of medical

devices shall -

• ensure their products

conform to EPSP

• ensure their products are

manufactured in accordance

with GMP

• collect evidence of

conformity

CAB verifies evidence of

conformity

PRE-MARKET PLACEMENT ON-MARKET POST-MARKET

MEDICAL DEVICES ARE

REGISTERED

• All Manufacturers (or LARs) apply for register

medical devices

MANUFACTURERS AND

DISTRIBUTORS APPLY

FOR LICENCE

• ensure compliance to GDP & advertising

requirements- Distributor

• apply for establishment license to distribute

medical devices

MDA monitors compliance to requirements & takes appropriate

actions in accordance with the provisions of the law

Premarket

Definition

Device

Manufacturer

Labelling

Brief Info

Instruction for

Use

Standards

Indigenous

International

Essential

Principles

Essential

Principles

6 General

Principles

11 Design and

Manufacturing

Conformity

Assessment

Declaration of

Conformity

QMS / GDPMD

CSDT

Technical Documentation

Classification

4 risk classes

Risk Criteria

Regulator

Documentation Review

Register Medical

Device

Post market Surveillance

Procedure

Establishment

Intended Use

Indication

Contra-IndicationEstablishment DetailsRegulation Info. Details

Premarket

Definition

Device

ManufacturerLabelling

Brief Info

Instruction

for Use

Standards

Indigenous

International

Essential Principles

6 General

11 Design and

Manufacturing

Conformity

Assessment

Declaration of

Conformity

QMS / GDPMD

CSDT

Technical

Documentation

Classification

4 risk

classes

Risk

Criteria

Regulator

Documentation

review

Register Medical Device

Post market

Surveillance

Procedure

Establishment

Intended Use

Indication

Contra-IndicationEstablishment Details

Regulation Info

Details

Clinical Safety of Medical

Device

Clinical

Investigation

Data/Result

Evaluation:

Data

AppraisalSuitability

Contribution

of Results to

Safety

Performance

Criteria for

Appraisal

Clinical Evidence

Ethical CommitteeClinical Investigation

Design

Quality

Records

Clinical

Experience

Report

Literature

search

Considering the need for a

clinical investigation

Testimonial from

users

Systematic

Review

Compliance of

Evidence

Risk Benefit

Qualitative

Data

Quantitative

Data

Pivotal Data

Premarket

Definition Labelling

Intended

Use

Instruction

for Use

Standards

Essential

Principles

Conformity

Assessment

Declaration of

Conformity

QMS / GDPMD

CSDT

Technical

Documentation

Classification Regulator

Documentation

Approve

Registration

Post market

Surveillance

Procedure

Clinical Safety of

Medical Device

Clinical Investigation

Data/Result

Evaluation:

Data

AppraisalSuitability

Contribution of

Results to

Safety

Performance

Criteria for

Appraisal

Systematic Review

Compliance of

Evidence

Risk Benefit

Clinical Evidence

Ethical CommitteeClinical Investigation Design

Device

Manufacturer

Indigenous

International

6 General

11 Design and

Manufacturing

4 risk

classes

Risk

Criteria

Quality

Management

System (QMS)

Supplier/

Product

Controls

Auditing Auditing in SG4

Risk

Management

Management

Responsibilities

Documentation and Communication

Process

ValidationInstallation Qualification (IQ)

Operational Qualification (OQ)

Performance Qualification (PQ)

Delivery,

Measurement and

Monitoring

Feedback and Communication

Statistical Method and Tools

Processes that should be validated

Conduct of a validation

Use of Historical Data

Quality Records

Clinical Experience

Outsourcing

Planning

Design and Development

Traceability

Purchasing Controls and Acceptance Activities

Production and Process Controls

Servicing

Analysis of Data

Corrective and Preventive Action

(CAPA)

Maintaining a state of

validation

Planning

Selection of

potential supplier

Supplier Evaluation

and Acceptance

Finalization of controls

and responsibilities

Report

Literature search

Considering the need for a

clinical investigation

Testimonial from

users

Safety via

clinical

evidence

Safety via

QMS

Qualitative Data

Quantitative Data

Pivotal Data

MEDICAL DEVICE REGULATION APPLICATION

MANUFACTURER

Device

Requirements/Intended

Use

Design

Input/Specifications

Design

Design Verification

Pilot Production

Device Validation

Manufacturing

Placing On The Market

Market Performance

Obsolescence/disposal

Definitions

The Essential

Principles/Standards

QMS Design Control/ Risk

Analysis

QMS Design Control/ Risk

Assessment

QMS GMPQMS GMP

Product Lifecycle

Start

Product Lifecycle

End

QMS Design Control/ Risk

Assessment

Process ValidationProcess Validation

Clinical Evidence

QMS GMP

Labelling/Advertisement

QM

S a

nd

Ris

k M

an

ag

em

en

t a

re a

pp

lica

ble

th

rou

gh

ou

t th

e c

om

ple

te p

rod

uct

life

cycl

e

Te

chn

ica

l In

form

ati

on

Device Classification

CS

DT

Conformity Assessment

Registration of Medical Device

Approval Registration

Usage, Maintenance

and Servicing

Post Market Surveillance

and Vigilance

Au

dit

s –

Inte

rna

l a

nd

Ext

ern

al

Ce

rtif

ica

tio

n

Co

ve

rag

e o

f th

e c

om

ple

te q

ua

lity

ma

na

ge

me

nt

syst

em

• Design & development

• Manufacture, import/

export

• Packaging, labeling,

storage

POST-MARKETPRE-MARKET PLACEMENT

ON MARKET

• Distribution

• Supply

• Advertising

• Surveillance & vigilance

• Installation, T&C,

maintenance, calibration,

repairs

• Operation, usage

• Decontamination,

decommission, disposal

Why the WHO Model?

Medical Device Lifecycle – What are

the Activities?

Elements of Regulatory Program

USEUsage, personnel,

maintenance

DEVICESafety, quality and

Performance according to EPSP

ACTIVITIESPre-market, placement on the

market, post-market

AUTHORITY TO GOVERN THE ELEMENTS

MEDICAL DEVICES LIFE CYCLE IN MEDICAL DEVICES LIFE CYCLE IN MEDICAL DEVICES LIFE CYCLE IN MEDICAL DEVICES LIFE CYCLE IN

HEALTHCARE FACILITIES. Implications and HEALTHCARE FACILITIES. Implications and HEALTHCARE FACILITIES. Implications and HEALTHCARE FACILITIES. Implications and

roles of regulation roles of regulation roles of regulation roles of regulation

Procurement

Usage

Disposal

Hosp. DevicesHosp. Devices

register

Incident

reporting

Assessment HTA

Device

Assessment-HTA

Training

Replacement Planning,

User

requirements

Field Safety

Corrective

Actions

Installation/Testing &

Commissioning/Acceptance

MDA

Devices register

Establishment

License

Maintenance

MDA Devices

registry

Compentency of

Biomedical Engrs

Compentency of

Biomedical Engrs

Hosp. ensure

Devices are regtrd

Est. icenced

Hosp. ensure

Devices are regtrd

Est. licenced

Hosp. Hosp. ensure

T&C done

Technology

pressureFast changing (online)

HarmonisationStandards/regulations

Customer’s

expectationFast, quality ,cost

Training and

capacity buildingCompetency, knowledge

AwarenessDialog, Campaign

Regulatory70,000 device, impact

EnforcementLegal capability

StandardsMandatory, voluntary,

industry

Inter Agency

CooperationMDPWG, AHWP GHTF

GlobalisationWTO, Bilateral

The Medical

Device Authority

Challenges to the Authority

Medical Device

Regulatory Control

Program

Training for Regulators Premarket Requirements

Placement on Market

Post Market Requirements

Act 738

Fees and BudgetaryAct/Regulation/

Guidance

Notes/QMS

Harmonisation

National/International

Affairs and Policy

Computerization (ICT)

Resource Centre

Capacity

BuildingACT 737

Awareness program

for

Consumer/End

User/Manufacturer/

Trader/Distributor/

Policy

Marker/researcher/ etc

Infrastructure

Legal

Framework

Medical

Device

Authority

MRA/Agreements

Enforcement

International

Forums

Human Resource

Finance

Legal Support

Thank You