MEDICAL DEVICE

COMPETENCY REGULATORY PROGRAMME

IN MALAYSIA

SASIKALA DEVI THANGAVELU MEDICAL DEVICE AUTHORITY

MINISTRY OF HEALTH MALAYSIA

MEDICAL DEVICE

COMPETENCY REGULATORY PROGRAMME

IN MALAYSIA 11TH MAY 2016

SASIKALA DEVI THANGAVELU

MEDICAL DEVICE AUTHORITY

MINISTRY OF HEALTH MALAYSIA

2

CONTENT

3

MEDICAL DEVICE INDUSTRY IN MALAYSIA

MEDICAL DEVICE REGULATORY REQUIREMENT IN

MALAYSIA

MEDICAL DEVICES REGULATORY PROGRAM IN

HEALTHCARE INSTITUTION

MEDICAL DEVICE COMPETENCY REGULATORY

PROGRAMME

COMPETENCY BASED ON MS2058

LISTING IN MDA REGISTRY

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

consumption.

There are 1915 establishment dealing with medical devices in

Malaysia.

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.

MEDICAL DEVICES INDUSTRY IN

MALAYSIA

MEDICAL DEVICE REGULATION :

OBJECTIVES

5

Regulatory Model is based on WHO Model.

Basis of regulation: EPSP

Definition for medical device based on GHTF/WHO

Risk based classification ABCD

International Standards -a similar level of quality

assurance QMS ISO13485/ISO14971

GHTF Guidance Documents

Harmonised with the AMMD

HARMONISED MEDICAL DEVICE REGULATION

ELEMENTS OF REGULATORY PROGRAM

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ACTIVITIES Pre-market, placement

In the market,

post-market

USE Usage, personnel,

Maintenance, T&C,

Disposal

DEVICE Safety, quality and

Performance according

to EPSP

MEDICAL DEVICE REGULATORY

FRAMEWORK:

WHO REGULATORY MODEL

ESTABLISHMENT: MANUFACTURER

CONCEPTION

AND

DEVELOPMENT

MANUFACTURE PACKAGING

AND

LABELING

ADVERTISEME

NT SALE USE DISPOSAL

/ USE

Use Maintenance, Installation, Testing &

Commission, Competency

Disposal

ESTABLISHMENT/USER/

TECHNICAL PERSONNEL

ESTABLISHMEN

T

• USER

• TECHNICAL

PERSONNEL

ESTABLISHMENT

:

• MANUFACTUR

ER

• AR

• DISTRIBUTOR

• IMPORTER

MANUFACTURER

MEDICAL DEVICES LIFE CYCLE IN

HEALTHCARE FACILITIES

Acquisition

Use

Disposal

Hosp. Devices

register Incident

reporting

Device

Assessment-HTA

Training

User

requirements

Field Safety

Corrective

Actions

Testing &

Commissioning

Devices

register

Maintenance

SECTION 5

& SECTION

15

SECTION

43

SECTION

43

SECTION

43

SECTION

43

Hospitals ensure

Devices are registered &

Establishments licensed

MEDICAL DEVICES REGULATORY

PROGRAM IN HEALTHCARE INSTITUTION

10

COMPETENCY

PROGRAM

INSPECTION

PROGRAM

BIOMEDICAL

ENGINEERING

MGT

PROGRAM

DISPOSAL

PROGRAM

MEDICAL DEVICE COMPETENCY

REGULATORY PROGRAMME

This regulatory programme outlines the development of

competency regulatory program for the user , technical

personnel ,trainer and biomedical engineering management

personnel based on MS2058 standard and the Medical Device

Act 2012 [Act 737].

The aim of this program is to ensure only competent

personnel with appropriate qualification and competency shall

use, test, commission, maintain and dispose medical device. The

implementation of this regulatory program shall ensure the

safety and performance of the medical device throughout the

life span of the device.

COMPETENT PERSON

The Certification of a person who has

demonstrated excellence in theoretical as well as practical knowledge in the principles of medical device technology

demonstrated knowledge to perform installation, maintenance, T&C, calibration of medical device

demonstrate Continuous professional, knowledge, skill and development in medical device technology.

COMPETENCY REGULATORY

FRAMEWORK

12

Tec

hn

ica

l P

ers

on

ne

l(T

P)

•Qualification •Training •Assessment •Practising Certificare

Me

dic

al D

evi

ce

Tra

inin

g B

od

y

• Registered with ROC

• Listed in MDA Registry

• Conduct Training Based on Approved Scope

Co

mp

ete

nc

y C

ert

ific

ati

on

Bo

dy(

CC

B)

• Registered with

ROC • ISO17024

Accredited • Assessment/

certification • Monitoring

Training Provider

• Develop Curriculum with the Working group.

Me

dic

al D

evi

ce

Au

tho

rity

•Policy and regulatory requirements •Develop guidance •Competency Registry •Develop curriculum •Audit CCB /TB • Approve CCB/TP/ Practising Certificate

BIOMEDICAL ENGINEERING

COMPETENCY LEVEL BASED ON

MS2058

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COMPETENCY

LEVEL Vs MD

BASIC MEDICAL

DEVICE

INTERMEDIATE MD

HIGH MD

COMPETENCY

LEVEL Vs SKILL

KNOWLEDGE ,

OPERATIONS,

SAFETY

SERVICING

,REPAIR

MANAGEMENT

MEDICAL DEVICE

CATEGORY

RADIOLOGY &

IMAGING

LABORATORY

DIAGNOSTIC

THERAPEUTIC

Implementation of the curriculum will be managed by the Certification

Body in line with ISO17024 standards

BIOMEDICAL ENG.

COMPETENCY LEVEL

LEVEL 1: CERT A

LEVEL 2: CERT B

LEVEL 3: CERT

C1,C2,C3,C4

EQUIPMENT

SPECIALIST; CERT D

MANAGEMENT

COMPETENCY REQUIREMENT

TECHNICAL PERSONNEL

• LEVEL1:

• MODULE1 BASIC MD

• MODULE 2 ANATOMY & PHYSIOLOGY

• MODULE 3 REGULATORY REQUIREMENT

• MODULE 4 MD SAFETY REQUIREMENT

• LEVE2 INTERMEDIATE MD

• LEVEL 3 HIGH MD

• TECHNICAL SPECIALIST

• MANUFACTURER TRAINING

• LEVEL 1

TRAINER

• T1

• TOT

• LEVEL2

• REGULATORY TRAINING

• T2

• TOT

• LEVEL3

• REGULATORY TRAINING

• T3

• TOT

• LEVEL 3

• CERT D

• REGULATORY TRAINING

USER

• CPD

• USER TRAINING

• REGULATORY TRAINING

MANAGEMENT

• MGT1

• MGT2

• MGT3

• LEVEL1

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TRAINING BODY[TB],COMPETENCY

CERTIFICATION BODY [CCB],TRAINER AND

TECHNICAL PERSONNEL [TP] LISTING IN MDA

REGISTRY

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Certification by CCB based

on ISO17024

Competency Certification

Body (CCB) Will Manage

the assessment and

certification process

CCB will issue certificate

to candidates

CCB will ensure quality in

all competency

assessment

Candidate to submit

–RPL ,RPA and

training certificates

to MDA

TB/CCB

Shall apply to

MDA

Apply

Approval by

MDA

and

shall be listed

in the Registry

Assessment

and audit by

MDA

MDA will assess ,

issue practising

certificate and shall

list in the Registry

Candidate

[Trainer/TP]

shall apply to MDA

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