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2011/SOM1/SCSC/CON1/012 Session 7 Malaysia’s Experience in Regulating the Medical Device Sector Submitted by: Malaysia 6 Conference

2011/SOM1/SCSC/CON1/012

Session 7

Malaysia’s Experience in Regulating the Medical Device Sector

Submitted by: Malaysia

2011/SOM1/SCSC/CON1/012 Session 7 Malaysia’s Experience in Regulating the Medical Device Sector Submitted by: Malaysia 6 Conference

6 th Conference on Good Regulatory Practice Washington, D.C., United States 1-2 March 2011

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Regulating the the Medical

Mala yy sia’s ex pp erience

sia’s ex erience inin

Device Sector

Device Sector

Regulating

Medical

Mala

The Medical Device Control Division , Ministry o f Health Malaysia

Present status: Present status: Except: Except: •• •• Radiation emitting devices e.g. Radiation emitting devices e.g.

Present status:

Present status:

Except:

Except:

Except: Except: •• •• Radiation emitting devices e.g. Radiation emitting devices e.g. ray,, CT xx--ray CT,,

••

••

Radiation emitting devices e.g.

Radiation emitting devices

e.g.

ray,, CT

xx--ray

CT,, mammo

mammo

Act 304

Act

304 –– enforced

enforced since

since

1974

1974

Regulatory status in Malaysia

There is no statutory pre- market, placement on market,post market

requirements for the registration and control of medical devices before they can be placed and

used in Malaysia

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Problems with with Medical

Problems

Medical Device

Device

Public health & safety issues

Unavailability of premarket control to assess safety, effectiveness and quality of medical devices Inadequate information for the public and health professionals to make informed choices on medical devices Lack of control over the usage of certain medical devices No postmarket reporting system to identify and monitor medical devices with problems in the market

Facilitating medical device trade & industry

No facilitation of local manufacturers to market their products globally

No favourable environment for the growth of the medical device industry

“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.”

World Health Organization guidance

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 )

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Background: Cabinet

Background:

Cabinet Decision

Decision

approved the proposal

16 Feb 2005: Cabinet

Program in Malaysia

to develop Medical

Device Regulatory

Establishment of

  • M e ca ev ces

August 2005:

Bureau

l D

di

i

  • Development of MD Bill & subsidiary legislations

  • Establishment of an organization to implement MD Regulatory Program Registration & Surveillance/ Vigilance System

  • Development of MD

Policy Objectives

Policy Objectives

To ensure safety, quality and performance of medical device over device life cycle

To protect patients and consumers

To facilitate trade

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Aims of

Aims

of the the Regulation

Regulation

Ensure public health and safety

  • Assurance for safety and performance

  • Timely access for beneficial medical technologies

  • Prevent dumping ground for unsafe and defective medical devices

Facilitate trade and industry

  • Conducive environment for medical devices manufacturing

  • Facilitate trade and export

  • Promote health tourism

aa Medical Devices Medical Devices Medical Devices Medical Devices Gloobbbbaallll SSSScenar Reggulation Reggulation cenariiiioo iiiinn ulation
aa
Medical Devices
Medical Devices
Medical Devices
Medical Devices
Gloobbbbaallll SSSScenar
Reggulation
Reggulation
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Re
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ulation
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Countries that currently regulate, or are in the process of developing regulations for, medical devices

South Africa Indonesia Malaysia China Uruguay Brazil Venezuela GHTF Founding Member Chinese Taipei Argentina Hongg Kong
South Africa
Indonesia
Malaysia
China
Uruguay
Brazil
Venezuela
GHTF Founding Member
Chinese Taipei
Argentina
Hongg Kong
Turkey
Philippines
Japan
United States
Chile
South Korea
Canada
Slovakia
Slovenia
Colombia
Cuba
*29 Members
EU
Australia
New Zealand
Thailand
India
Israel
Peru

Regulations inin Other

Regulations

Other Countries

Countries -- Laws

Laws &&

authorities for medical devices

authorities for medical devices

 
 

Laws/regulations

Regulatory authority

US

Safety Medical Devices Act

Center for Devices &

Medical Devices User Fee & Modernization Act

Radiological Health, FDA

Code of Federal Register Part 800 – 900

UK

Medical Devices Regulation 2002 under Consumer

Medicines & Healthcare

Protection Act 1987

Products Regulatory Agency

Australia

Therapeutic Goods Act 1989

Office of Devices, Blood &

Therapeutic Goods (Med Devices) Regulations 2002

Tissue, TGA

Canada

Food & Drug Act

Medical Devices Bureau,

Medical Devices Regulations (No 1101)

Therapeutic Product

Directorate

 

Medical Devices Regulations (No 1162) – Amendment

Medical Devices Regulations (No 1293) – Quality System

Japan

Pharmaceutical Affair Law

Ministry of Health, Labour &

Pharmaceutical Control Law

Welfare

Cabinet Orders & Ministerial Ordinances

Korea

General regulations, has not had in place documents

Medical Devices & Radiation

providing details for approvals specific to products

Health Dept, Korean FDA

Regulatory status in various countries

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Regulations inin Other

Regulations

Other Countries

Countries -- Laws

Laws &&

authorities for medical devices

authorities for medical devices

 
 

Laws/regulations

Regulatory authority

New

Medicines Act 1981

Medicines & Medical Devices

Zealand

Medicines (Database of Medical Devices) Regulations

Safety Authority

2003

China

The Regulation on Supervision & Administration of

State Drug Administration

Medical Devices

State Admin for Technical &

Quality Supervision

State Admin for Entry/Exit

Inspection & Quaratine

Thailand

Medical Device Act 1988

Medical Device Control

Ministerial Regulations 1 – 7

Division, Thai FDA

Philippines

Law governing medical devices is being drafted

Bureau of Health Devices &

Technology, Dept of Health

Singapore

Health Products Act

Center for Medical Device

Medical Devices Regulations

Regulation, HSA

Indonesia

Health Law No 23 1992

Directorate of Medical Device

Production & Distribution MoH

Regulatory status in various countries

Harmonization with the

Global Harmonization Task Force

Recommendations (GHTF)

“Medical devices should be designed and manufactured in such a way that, when used under the conditions and for the purposes intended and where applicable, by virtue of the technical knowledge, experience, education or training of intended users, they will not compromise the clinical condition or the safety of patients, or the safety of health of users or, where applicable, other persons, provided that any risks which maybe associated with their use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety”

(Essential principles of safety and performance of medical devices recommended by GHTF

(SG1NO20R5)

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Guiding Principles

Guiding Principles

The primary goal is to protect public health and safety

The level of regulatory control should be proportional to

the degree of risk Expedites timely availability and access to safe and beneficial medical devices and to prevent unsafe and ineffective medical devices from entering the market

Elements of control from design through disposal stages shall be put in place to ensure continued safety and quality

Inline with global harmonization effort to minimize regulatory barriers, facilitate international trade, improve access to new technologies and to reduce the cost of implementing regulation

Framework of the Malaysian

Framework of the Malaysian

MEDICAL DEVICE

MEDICAL

DEVICE

REG UU LATORY SYSTEM

REG LATORY SYSTEM

Medical Devices Bureau

MINISTRY OF HEALTH MALAYSIA

Framework of the Malaysian Framework of the Malaysian MEDICAL DEVICE MEDICAL DEVICE REG UU LATORY SYSTEM
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Act Resources Allocation Standards Regulations Survey the usage and inventory Registration and Vigilance system Guidance Notes/
Act
Resources
Allocation
Standards
Regulations
Survey the usage and inventory
Registration and
Vigilance system
Guidance Notes/
Code of good practices
Implement control and enforcement
Establish
Policy
Directions
Input from all
stakeholders

The Medical Device Regulatory Framework

Action Plan

Regulatory Framework

Regulatory

Framework

 Enforcement and investigation  Post‐market requirements  Pre‐market requirements  Requirements for placement on the
 Enforcement and investigation
 Post‐market requirements
 Pre‐market requirements
 Requirements for placement on the
market
 Definition of a medical device

Medical Devices Bureau

MINISTRY OF HEALTH MALAYSIA

Regulatory Framework Regulatory Framework  Enforcement and investigation  Post‐market requirements  Pre‐market requirements  Requirements
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Definition

Definition

benefit to patients devices system with myriad uses device products in some device products in some
benefit to patients
devices
system
with myriad uses
device products in some
device products in some
 Complexity from
400,000 different medical
400,000 different medical
 Wide array of products
10,000 product categories
10,000 product categories
• Range of medical
Global market p lace:
simple to sophisticated
of risk, whilst providing
 Cover a wide spectrum

Medical Devices

Medical Devices

Medical Device Medical Device Non-Invasive •Therapeutic •Diagnostic Invasive (Non-Active) Others Implantable Class D Class C Class
Medical Device
Medical Device
Non-Invasive
•Therapeutic
•Diagnostic
Invasive
(Non-Active)
Others
Implantable
Class D
Class C
Class B
Class A
Active

ENGINEERING SERVICES DIVISION MINISTRY OF HEALTH

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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

Medical Devices Bureau

MINISTRY OF HEALTH MALAYSIA

Definition

A Medical Device

regulatory program

applies to all medical

devices on the

Malaysian market

The term “medical device”

What is a medical device?

covers any products used

of illness or handicap but

monitoring or treatment

diagnosis, prevention,

in healthcare for the

excludes drugs

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Risk ‐‐ Based

Risk

Based Classification

Classification for

for

Regulatory Control

Regulatory

Control

Medical device is classified based on the risk associated with the vulnerability of the human body, the technical design and the manufacture of the medical device

Risk-based classification;

  • - Class A (low)

  • - Class B (low moderate)

  • - Class C (high moderate)

  • - Class D (high)

Regulatory control should be proportional to the level of risk associated with a medical device

Riskbased classification & regulatory control

B C D A Regulatory requirements
B
C
D
A
Regulatory requirements

Device risk

Risk ‐‐ Based Classification &&

Risk Based Classification

Regulatory Control

Regulatory

Control

Moderate Pacemakers and their leads, implantable defibrillators, implantable High D ventilator deep wound dressing, defibrillator, radiological
Moderate
Pacemakers and their leads, implantable defibrillators, implantable
High
D
ventilator
deep wound dressing, defibrillator, radiological therapy equipment,
oxygenator, blood bag, contact lens disinfecting/cleaning products,
Moderate
Lung ventilator, orthopaedic implants, baby incubator, blood
High-
C
ray films
hydrogel dressings, patient controlled pain relief, phototherapy unit, x-
circuits, aspirator, external bone growth simulators, hearing aids,
Class
Hypodermic needles, suction equipment, anaesthetic breathing
Low-
B
stethoscopes, walking aids
thermometer, examination light, simple wound dressing, oxygen mask,
Simple surgical instruments, tongue depressor, liquid-in-glass
Low
A
infusion pumps, heart valves, inter-uterine contraceptive devices,
neurological cathethers, vascular prostheses and stents
Device examples
Risk Level
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Scope of regulation

Scope

of regulation

PRE‐MARKET PLACEMENT POST‐MARKET ON MARKET
PRE‐MARKET
PLACEMENT
POST‐MARKET
ON MARKET

• Design & development

• Distribution

• Surveillance & vigilance

• Manufacture, import/

• Supply

• Installation, T&C,

export • Packaging, labeling, storage

• Advertising

maintenance, calibration, repairs • Operation, usage • Decontamination, decommission, disposal

PreMarket Requirements

•• What && perform as the for? device qualilityty intended processes perform as carried out iiss
•• What
&& perform as
the
for?
device
qualilityty
intended
processes
perform as
carried out
iiss sasaffe, e, qua
ensure that
that aa
intended for?
medical device
What are
processes
carried
ensure
medical
are the
out toto

Define the Medical Device

Define the Medical Device

Define the Medical Device Define the Medical Device Classify according toto risks Classify according risks Meets

Classify according toto risks

Classify according

risks

Define the Medical Device Define the Medical Device Classify according toto risks Classify according risks Meets

Meets the essential principles

Meets the essential principles

Define the Medical Device Define the Medical Device Classify according toto risks Classify according risks Meets

manu acturing principles

Manufactured according

Manufactured according

acturing principles

manu f f

l

l

Define the Medical Device Define the Medical Device Classify according toto risks Classify according risks Meets

Labeling, packaging, marking

Labeling, packaging, marking

Define the Medical Device Define the Medical Device Classify according toto risks Classify according risks Meets

Carry out

Carry out

Conformity assessment

Conformity assessment

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PostMarket Requirements

• Define the
• Define the

requirements to b be

monitor safety and fulfilled to. How to, performance of  continuously medical devices on
monitor safety and
fulfilled to. How to,
performance of
 continuously
medical devices on
on any problems related  take corrective actions to medical devices on the market the market
on any problems related
 take corrective actions
to medical devices on
the market
the market
Recall Field Correction Surveillance and Mandatory Reporting Distribution Records Vigilance System Complaints Handling
Recall
Field Correction
Surveillance and
Mandatory Reporting
Distribution Records
Vigilance System
Complaints Handling
3/28/2011 Post ‐ Market Requirements • Define the requirements to b be monitor safety and fulfilled
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Overview oo ff The

Overview

The Regulatory

Regulatory System

System

PRE-MARKET

PLACEMENT ON-MARKET

POST-MARKET

PRE-MARKET REVIEW

Manufacturers of medical

devices shall -

ensure their products

conform to EPSP

ensure their products are

manufactured in

accordance with GMP

collect evidence of

conformity

MEDICAL DEVICES

REGISTRATION

Manufacturers (or LARs)

apply for register medical

devices & establishment

license to manufacture

DISTRIBUTORS

LICENSING

Distributors shall -

ensure compliance to

MDA allows -

MDA allows -

registered

registered

medical devices

medical devices

to be placed

to be placed

into the market

into the market

licensed

licensed

establishments

establishments

to do their

to do their

business

business

MEDICAL

MEDICAL

SURVEILLANCE & VIGILANCE

Establishments shall-

monitor safety & performance of

their products

carry out post-market

obligations, eg user training,

complaint handling, FSCA, recall

USAGE && MAINTENANCE

USAGE

MAINTENANCE

Users shall use, maintain &

Users shall use, maintain &

GDP & advertising requirements DEVICES WILL DEVICES WILL dispose off medical devices dispose off medical devices

GDP & advertising

requirements

DEVICES WILL

DEVICES WILL

dispose off medical devices

dispose off medical devices

appropriately

appropriately

CAB verifies evidence of

conformity

apply for establishment

license to distribute

medical devices

BE MADE

BE MADE

AVAILABLE ON

AVAILABLE ON

THE MARKET

THE MARKET

Users shall apply for permit to

Users shall apply for permit to

use/operate designated medical

use/operate designated medical

devices

devices

MDA monitors compliance to requirements & takes appropriate actions in accordance with the provisions of the
MDA monitors compliance to requirements & takes appropriate
actions in accordance with the provisions of the law

Essential Principles

Essential

Principles oo ff Safety

Safety &&

Performance

Performance

• A medical device shall
• A medical device shall
requirements of safety and performance conform to essential
requirements of safety
and performance
conform to essential
  • 11 design & manufacturing GHTF/SG1/N41R9:2005: Essential Principles of Safety & Performance of Medical Devices

Essential Requirements of

  • 6 general requirements

Safety & Performance of

Medical Devices

requirements

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Essential Principles o f Safety & Performance
Essential Principles o f Safety &
Performance

3) Medical device should achieve the intended/specified performance and be designed, manufactured and packed in such a way that it is suitable for the functions within the scope of the definition of medical device

2) In the design and construction of medical device, hazards, associated risks and foreseeable misuse from the intended use should be identified, eliminated/reduced; any residual risks that cannot be eliminated, protection measures should be taken and should be informed to users

1) No compromise on clinical condition and safety of patients, health and safety of users and other persons when use under the conditions and for the purposes intended

5) Characteristics and performances during the intended use should not be adversely affected under transport and storage conditions

4) Characteristics and performances should not be adversely affected by stresses during normal conditions of use and proper maintenance

6) The benefits outweigh any undesirable side effects

Back

Essential Principles

Essential

Principles oo ff Safety

Safety &&

Performance

Performance

10) Information supplied by the manufacturer 11) Performance evaluation including, where appropriate, clinical evaluation

8) Protection against the risks posed to the patient by supplied energy or substances

6) Requirements for medical devices connected to or equipped with an energy source

9) Protection against the risks posed to the patient for devices for selftesting or self administration

1) Chemical, physical and biological properties 2) Infection and microbial contamination 3) Manufacturing and environmental properties 4) Devices with a diagnostic or measuring function 5) Protection against radiation

7) Protection against mechanical risks

Medical Devices Bureau

MINISTRY OF HEALTH MALAYSIA

Essential Principles Essential Principles oo ff Safety Safety && Performance Performance 10) Information supplied by the
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Who & What will be Regulated? Responsible parties Regulated activities/responsibilities L oca manu acturers l f
Who & What will be Regulated?
Responsible parties
Regulated activities/responsibilities
L
oca manu acturers
l
f
T
o ensure pro
d
ucts meet essent a
i
l
pr nc p es o
i
i
l
f
sa ety
f
&
performance (EPSP) and are manufactured in accordance with
good manufacturing practice (GMP)
To apply for product registration
Exporters
To monitor safety & performance and to take corrective actions
on problems related to products in the market
Local authorized
To act on behalf of foreign manufacturers with regard to the
representatives (LARs) of
manufacturer’s responsibilities under the Malaysian laws
foreign manufacturers
Importers
To ensure compliance with requirements of good distribution
practice (GDP), eg cleanliness & suitability of premises, storage &
Distributors
stock handling, traceability, product complaints, etc
Conformity assessment
To verify evidence of conformity to EPSP, GMP, GDP
bodies (CABs)
Users of medical devices
To ensure competencies of users & persons involve in
on patients
maintenance of medical devices
To apply for permit to use designated medical devices

Coordination with with

Coordination

Stakeholders

Stakeholders

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Essential Essential Principles Principles of of Safety Safety && Performance Performance 1) 2) 3) 4) 5)
Essential
Essential Principles
Principles of
of Safety
Safety &&
Performance
Performance
1)
2)
3)
4)
5)
Chemical, physical and biological properties
Infection and microbial contamination
Manufacturing and environmental properties
Devices with a diagnostic or measuring function
Protection against radiation
6)
Requirements for medical devices connected to or equipped with
an energy source
7)
Protection against mechanical risks
8)
Protection against the risks posed to the patient by supplied
energy or substances
9)
Protection against the risks posed to the patient for devices for
self‐testing or self administration
10)
Information supplied by the manufacturer
11)
Performance evaluation including, where appropriate, clinical
evaluation
Back

Empowerment

Empowerment

Empower the industry to self declare for Class A devices

Manufacturer themselves choose the regulatory control route of medical devices they manufacture based on the risk classification

Abridge system, whereby products can be registered easily if they have been approved by the 5 founding members of the GHTF.

Conformity Assessments are carried out by a third party

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Risk

Risk

Based Regulatory

‐‐ Based

Regulatory Control

Control

Regulatory control is proportional to the level of risk associated with a medical device

 

Technical

Prepare tech

Prepare tech

Prepare tech

Prepare tech

documentation

document

document

document

document

 

Submit for review

Submit for review

Submit for review

Regulato ry requirements

Post-market

Establish PMS

Establish PMS

Establish,

Establish,

surveillance

Maintain PMS

Maintain PMS

maintain PMS

maintain PMS

system (PMS)

Make available

Make available

for audit

for audit

 

Quality mgmt

Establish &

Establish &

Establish,

Establish,

system (QMS)

maintain QMS

maintain QMS

maintain full QMS

maintain full QMS

excl design

excl design

Make available

Make available

requirement

requirement

for audit

for audit

 

Declaration of

Prepare, sign &

Prepare, sign &

Prepare, sign &

Prepare, sign &

conformity

submit

submit

submit

submit

 

Class A

Class B

Class C

Class D

Medical device class/risk

The Use o f Harmonized Standards

– To demonstrate conformance to essential principles of safety and performance

– To demonstrate conformance to management and manufacturing standards

– Promoting harmonization by adopting international standards

– The use of standards helps in

• improving productivity • improving market competitiveness • improving export capability • reducing cost

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Thank You You

Thank