PRESENTATION TO HEALTHCARE FACILITIES

11.2.2016

IR.SASIKALA

MEDICAL DEVICES AUTHORITY

MINISTRY OF HEALTH MALAYSIA

MEDICAL DEVICES AUTHORITY

ACT 738

THE MEDICAL DEVICE AUTHORITY

(MDA)

Presentation to Healthcare Facilities

11.2. 2016

Medical Devices Regulatory System

Medical Device Authority Act 2012 (Act 738)

Functions of MDA

Medical Device Act 2012 (Act 737)

Challenges to the Authority

The Industry in Malaysia

CONTENT

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

BOARD MEMBERS (MDA)

A Statutory Body with the

following members 1. DG of Health as the

Chairman

2. Chief Executive

3. Min of Health

4. Min of Finance

5. 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

Committees appointed by MDA

- to assist it in the performance of

the functions of the Authority

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

Market

Access

and

Control

Medical

Device

Product

Control

Facilitate

trade and

Industry

Ensure public

health and

safety

Establishment

Control

Export

Permit List of

Products

Int. Standards

List of

Licensed

Est

Harmonised

Regulations

Permit Of

DMD Usage

Maint.

Disposal

Product

Registration

C

D

B

A

CAB

Regist. Manuf.

Dist. Importer AR

Establish.

Licence

Advertis

ment QMS

Product

POST-MARKET VIGILANCE AND SURVEILLANCE SYSTEMS & ENFORCEMENT

Registry Registered products,

Est license issued

Harmonisation ACCSQ-MDPWG,

IMDRF, AHWP, APEC

GLP Project CMA, Competency for

auditors

Training and capacity

building Competency, knowledge

Organisational Structure, posts

Licensing and

Registration 1700 EST License

70,000 Medical device

registration

Post market and

Enforcement Legal capability, enforcement

capability

Human

Resource Mgt

Finance SAGA, Investments

ICT Upgrading and

The Medical

Device

Authority

CHALLENGES TO THE AUTHORITY

THE INDUSTRY IN MALAYSIA

Around 1942 establishment of medical device in the country-

(manufacturing, importer, exporter and distributor) extracted

from MeDC@St system

Export revenues of RM 13.49 Billion in 2014

Export CAGR of 8 % per annum from 2005 – 2015

Malaysia is majoring in surgical and examination gloves globally

Source: AMMI / PEMANDU/ MIDA /MATRADE

52.9 47.1 47.1

14.20%

10.10%

6.10%

16.80%

Ophthalmic

Catheters, syringes

Electro mechanical MD

Others

MALAYSIA

EXPORTS OF MEDICAL DEVICES

RM

Billion

RM

Billion

Gloves Medical

Devices

(Excluding

Gloves)

Source: Malaysia Statistics Department, MATRADE, AMMI

Total Exports in 2014: RM13.49 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

Philippines

Mexico

Australia

CONCEPTUAL QUALITATIVE OVERVIEW OF CURRENT

NATIONAL MEDICAL DEVICE REGULATORY SYSTEMS -

TRENDS lo

w

hig

h

high low

Harm

on

izati

on

(G

HT

F /

MD

PW

G)

Comprehensiveness

Singapore

EU, EFTA

Canada

Arab Saudi

Chinese Taipei

Japan

USA Korea

Thailandd

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

THANK YOU