Chief Executive

Medical Device Authority

Global trend in Medical Devices

Global trend demand for Medical Devices

Estimated to about USD 290 billion 2009

Estimated increase:- USD 300 billion -2011

Estimated 10% increase annually

Malaysian Market

Malaysia currently imports around 95% of the medical device for its consumption

The medical devices industry in Malaysia is a 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 2.3 2.3

28%

12%

13%

12%

12%

11% 5% 7%

Reusable instruments

Radiation devices

Opthalmic

Catheters, syringes, needles & sutures

Contraceptives

Electro mechanical MD Orthopedic implants

Others

Malaysia Exports of Medical Devices

RM

Billion

RM

Billion

Gloves Medical Devices (Excluding Gloves)

Source: Malaysia Statistics Department, MITI, MIDA, PEMANDU

Total Exports in 2011: RM11.7 Billion

Consumables Surgical Instruments,

Implants & Clinical Devices Healthcare Equipment

Technology Latex

Plastic Metal Machining Electronics Furniture

Products

Companies

Supporting Infrastructure

Sterilization Certification Packaging Biocompatibility And Clinical Trial

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

Industry Group

Education Training

Regulatory

Glove, Contraceptives,

Catheters, woundcare,

Orthalmology, IVD, SUD

Pacemaker, Orthopedics,

Surgical instrument

Radiation equipment,

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 )

Background

Policy direction: Cabinet decision 2005

Policy: Regulatory framework for the control of medical devices in Malaysia Based on & harmonized with global regulatory model Endorsed by WHO, in-line with WTO agreement Adopted by ASEAN member countries and major trading

partners eg USA, Japan, Canada, EU and Australia

Objectives of regulatory framework: To ensure availability, accessibility, safety and

performance of medical devices for patient care and public health

To facilitate trade and reduce technical barrier to trade To encourage innovations for economic growth

United States

Peru

Canada

Chile

Argentina Uruguay

Brazil

Colombia

Venezuela

South Africa

China

Thailand

Malaysia

Australia

New Zealand

Taiwan

South Korea

Japan

Israel

Slovenia

Slovakia

EU

*29 Members

Turkey

Hong Kong

Philippines

Indonesia

Countries that currently regulate, or are in the process of developing

regulations for, medical devices

Cuba

GHTF Founding Member

India

Laws/regulations Regulatory authority

New Zealand

Medicines Act 1981

Medicines (Database of Medical Devices) Regulations 2003

Medicines & Medical Devices Safety Authority

China The Regulation on Supervision & Administration of Medical Devices

State Drug Administration

State Admin for Technical & Quality Supervision

State Admin for Entry/Exit Inspection & Quaratine

Thailand Medical Device Act 1988

Ministerial Regulations 1 7

Medical Device Control Division, Thai FDA

Philippines Law governing medical devices is being drafted Bureau of Health Devices & Technology, Dept of Health

Singapore Health Products Act

Medical Devices Regulations

Center for Medical Device Regulation, HSA

Indonesia Health Law No 23 1992 Directorate of Medical Device Production & Distribution MoH

Regulations in Other Countries - Laws & authorities for medical devices

Regulatory status in various countries

Regulations in Other Countries - Laws & authorities for medical devices

Laws/regulations Regulatory authority

US Safety Medical Devices Act

Medical Devices User Fee & Modernization Act

Code of Federal Register Part 800 900

Center for Devices & Radiological Health, FDA

UK Medical Devices Regulation 2002 under Consumer Protection Act 1987

Medicines & Healthcare Products Regulatory Agency

Australia Therapeutic Goods Act 1989

Therapeutic Goods (Med Devices) Regulations 2002

Office of Devices, Blood & Tissue, TGA

Canada Food & Drug Act

Medical Devices Regulations (No 1101)

Medical Devices Regulations (No 1162) Amendment

Medical Devices Regulations (No 1293) Quality System

Medical Devices Bureau, Therapeutic Product Directorate

Japan Pharmaceutical Affair Law

Pharmaceutical Control Law

Cabinet Orders & Ministerial Ordinances

Ministry of Health, Labour & Welfare

Korea General regulations, has not had in place documents providing details for approvals specific to products

Medical Devices & Radiation Health Dept, Korean FDA

Regulatory status in various countries

Philippines

Mexico

Australia

CONCEPTUAL QUALITATIVE OVERVIEW OF CURRENT NATIONAL MEDICAL DEVICE REGULATORY SYSTEMS - TRENDS lo

w

hig

h

high low

Har

mo

niz

atio

n (

GH

TF /

MD

PW

G)

Comprehensiveness

Singapore EU, EFTA

Canada Arab Saudi

Chinese Taipei

Japan

USA Korea

Thailand

China Brazil

Columbia Argentina

Pakistan

New Zealand

Bangladesh

India South Africa NOTES: 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

Laos Vietnam

Indonesia

Myanmar

Malaysia

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

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

Design & development Manufacture, import/

export Packaging, labeling,

storage

POST-MARKET PRE-MARKET PLACEMENT ON MARKET

Distribution Supply Advertising

Surveillance & vigilance Installation, T&C,

maintenance, calibration, repairs

Operation, usage Decontamination,

decommission, disposal

Scope of regulation-WHO Model

Medical Device Lifecycle What are the Activities?

MEDICAL DEVICES LIFE CYCLE IN

HEALTHCARE FACILITIES- ROLES

Procurement

Use

Disposal

Hosp. Devices register

Incident reporting

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

Hosp. ensure Devices are regtrd

Est. licenced

Hosp. ensure T&C done

Elements of Regulatory Program

USE Usage, personnel,

maintenance

DEVICE Safety, quality and performance, ERSP

ACTIVITIES Pre-market, placement on the

market, post-market

AUTHORITY TO GOVERN THE ELEMENTS

Standards

Guidance Notes/

Code of good practices

Regulations

Act

Survey the usage and inventory

Establish

Policy

Directions

Input from all

stakeholders

Registration and

Vigilance system

Resources

Allocation

Implement control and enforcement

Action Plan The Medical Device Regulatory Framework

Current Status

Medical Device Act (Act 737) 2012 Appointed date for the Medical Device Act is 1st July 2013

Medical Device Regulations 2012 Appointed date for the Medical Device Regulations is 31st December

2012

Medical Device Authority Act (Act 738) 2012 Appointed date for the Medical Device Authority Act is 15 March 2012

Chief Executive, officers, servants

MEDICAL DEVICE AUTHORITY

MINISTER OF HEALTH

Institutional st 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 p

ow

ers to

.. gives p

ow

ers to

MEDICAL DEVICE AUTHORITY http://www.mdb.gov.my

Medical Device Authority (Act 738) 2012

To provide for the establishment of the Medical Device Authority with powers to control and regulate medical device, its industries and activities, and to enforce the medical device laws, and for related matters

The Act may be cited as the Medical Device Authority Act (Act 738) 2012

Come into operation on the appointed date by the Minister by notification in the Gazette on the 15th March 2012

MEDICAL DEVICE

AUTHORITY (MDA)

A Statutory Body with the

following members - DG of Health as the Chairman

- Chief Executive

- a representative of Min of Health

- a representative of Min of

Finance

- not more than five persons

appointed by the Minister, who

have expertise and experience in

medical device matters

Functions of MDA

To implement, enforce, consider and recommend reform to the medical device laws

To perform the following :- - to regulate all matters

- to encourage & promote the development

- to provide consultancy & advisory service and any

other services,

in relation to medical device, its industries and activities

To utilize property of the Authority in such manner as the Authority may think expedient

To impose fees or charges for services rendered

Committees appointed by MDA

- to assist it in the performance of

the functions of the Authority

MEDICAL DEVICE AUTHORITY http://www.mdb.gov.my

The Authority challenges

MEDICAL DEVICE AUTHORITY http://www.mdb.gov.my

Medical Device

Regulatory Control

Program

Training for Regulators Premarket Requirements

Placement on Market

Post Market Requirements

Act 738

Fees and Budgetary Act/Regulation/

Guidance Notes/QMS

Harmonisation

National/International Affairs and Policy

Computerization (ICT)

Resource Centre

Capacity Building

ACT 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

MEDICAL DEVICE AUTHORITY http://www.mdb.gov.my

MISSION : To provide regulatory control of medical device industry in Malaysia through compliance of the act by ensuring safety and performance of medical device product to protect public

VISION : To become excellent medical device

regulatory authority recognised globally

CUSTOMER VALUE PROPOSITION: 1. Attributes -(Reliability, Consistent, Efficient), 2. Relationship -(Consultative, Customer-centric, Impartial), 3. Image -(Rule of Law-Ensure all documents process

efficiently and effectively compliance to regulatory)

MEDICAL DEVICE AUTHORITY http://www.mdb.gov.my

STRATEGIC THEME

Excellence in delivery through; 1. Technologically driven 2. Customer / Stakeholder strategic alliance

STRATEGIC RESULTS 1. Facilitate, timely & accurate execution of approvals 2. A systematic, reliable and secured data management 3. Collaborative, consultative relationship that exceed

customer, employees & stakeholders expectation

MEDICAL DEVICE AUTHORITY http://www.mdb.gov.my

Keys to success Initial budget obtained

Completed first phase of recruiting staff based on the approved list obtained when the BKPP cease to operate since 31 June 2012 for 60 staffs

Endorsement from MDA for the additional posts required for the full running of the MDA as approved by KKM

On going registration of products, licensing of establishment and registration of Conformity Assessment Bodies through MedCast IT based systems

MEDICAL DEVICE AUTHORITY http://www.mdb.gov.my

START UP SUMMARY

On going efforts to fill up promotional posts Completed recruitment processes and setting up

various human resource committees MDA has finalised and endorsed additional manpower

requirements Established a financial system ( Salary, Procurement &

Accounts) including committees to exercise its commitments

Established infrastructure (IT & Others) requirements to enable online to fulfill the regulatory system

MEDICAL DEVICE AUTHORITY http://www.mdb.gov.my

START UP SUMMARY

Established new Location and place of doing business

Established statutory identity and logo

Completed start up procurement of assets

On going Awareness program to industry, users and organisations

CARTA ORGANISASI PIHAK BERKUASA PERANTI PERUBATAN KKM (DILULUSKAN DALAM MESYUARAT JAWATANKUASA KHAS BAGI MENGKAJI JAWATANJAWATAN TINGKATAN TERTINGGI

BIL. 1/2012 PADA 16 APRIL 2012)

BAHAGIAN

DASAR, KOD & STANDARD

J 54

Petunjuk:-

KETUA EKSEKUTIF

Jusa Utama C

Jawatan Diisi

Jawatan Belum Diisi

CAWANGAN

PENILAIAN & PENDAFTARAN

PRODUK IVD

C48

C48

CAWANGAN

KAWALAN ESTABLISMEN &

BADAN PENILAIAN PEMATUHAN

(CAB)

CAWANGAN

DASAR & HUBUNGAN

ANTARABANGSA

J52

C48

CAWANGAN

SURVELAN & VIGILAN

CAWANGAN

AUDIT PEMATUHAN

C48

PEJABAT

PENASIHAT UNDANG-UNDANG

L 41

BAHAGIAN

PENDAFTARAN, PERLESENAN & PRA PASARAN

C54

-

CAWANGAN

PENGUATKUASAAN

J44

N36

SUMBER MANUSIA

/LATIHAN

CAWANGAN

ICT &

PENGURUSAN MAKLUMAT

F44

SETIAUSAHA PEJABAT

N 27/28/N32

ANGGOTA PIHAK BERKUASA PERANTI PERUBATAN\

CAWANGAN

PENILAIAN & PENDAFTARAN

PRODUK UMUM

C52

BAHAGIAN

PENILAIAN KLINIKAL

C 52

CAWANGAN

BANTUAN INDUSTRI

J44

CAWANGAN

PERHUBUNGAN AWAM

S44

-

CAWANGAN

KAWALAN PENGGUNAAN

J44

N17/22

PENTADBIRAN

W36

KEWANGAN/HASIL

N17/22

PENGURUSAN ASET

& PEROLEHAN

UNIT

KHIDMAT PENGURUSAN

N41

CAWANGAN

PENILAIAN KLINIKAL

UD 41/44/48/52/54

CAWANGAN

RUJUKAN SAINTIFIK

C48

CAWANGAN

PENYELIDIKAN

UD 41/44/48/52/54

MEDICAL DEVICE AUTHORITY http://www.mdb.gov.my

Information Technology Systems

Medical Device Computerised Application System (MeDCASt) will developed to support the scope of regulatory control in terms of product registration

It will also provide the basis for :

Licencing of establisments (manufacturer, Local Authorised Representative and importer) to enable them to register medical device

Register Conformity Assessment Body (CAB)

Pu

blic

U

ser/

Custo

me

r In

tra

ne

t S

ecure

lin

k

Authority web

page

Lists of licensed

establishment

Lists of

registered

Medical

Devices

Lists of

Safety Notice,

Alert

Lists of

recall medical

device

Pre-market

Medical

Device

Registration

Establishment

Licensing

Medical

Devices

Classification

Conformity

Assessment

Body (CAB)

Registration

On-market

Inspectorate

Advertisement

Watch Auditing

Complaint

Enforcement

Industrial Support

Bilateral/

Multilateral

Agreement

ISC R/

Standards

development

Export

Permit

International

Forum

Stakeholders enggagement,

consultation and training

Post-market

Incident

Reporting

Surveillance

and vigilance

Service

Provider

Registration

Designated

Device Premit

Competency

Registration

Management

System

Finance

Knowledge

Centre

Talent

Management

Policy and

Authority

secretariet

Quality

Management

System

electronic banking Custom

Code

RADIA, radiation

equipment (Act 304)

EPF, Sosco,

Income tax

MaHTAS

Establishment

License

Application

CAB

Registration

Application

Service

Provider

Registration

Application

Medical

Device

Classification

Competency

Registration

Application

Incident

Reporting

File &

Document

Management

Standards

Malaysia CMIS Bahagian Amalan

Perubatan (Private

Healthcare Facilities

Act) - Licensed premis

Current Government

ICT Initiative

THIS, HIS, PHIS, Aset

management, e-

mesyaurat

MITI, MIDA,

SEMITEC,

Biotech

Corp

Mohd Amin 2011

Lists of

registered

CAB

Export

Permit

Application

Trending

Lists of

competent

personnel

Lists of

registered

service

provider

SSA,

Local

Authority

Medical Device

Registration

Application

Architecture of 1MiDAS & Development Phase

2

3

4

5

6

1

1

1

1

1

Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4

2013 2014 2015

Medical Device: Implementation of the Act 737

Re

gist

rati

on

of

Pro

du

cts

and

CA

Bs

IVD

Phase 1: Registration of CAB

Phase 2: Registration of all Classes and IVD

Lice

nsi

ng

of

Esta

blis

hm

en

ts

Phase 3: Imposition of other obligations

Phase 2: Imposition of GDP for other establishments

Phase 1: Imposition of ISO13485 for

manufacturers

Voluntary Transition Mandatory

Thank You