UPDATES ON THE

ASEAN MEMBER

STATES

Washington, September 2014

WHERE WILL BE THE ASEAN COMMUNITY MEDICAL DEVICE

SECTOR BY 2020?

HOW IS IT

GOING TO

GIVE A

BUSINESS

IMPACT IN

THE

MEDICAL

DEVICE

SECTOR?

Facts and Figures

Indicators Unit 2012 2013p/

Total land area km2 4,435,617 4,435,617

Total population thousand 617,165 625,096

Gross domestic

product at current

prices

US$

million 2,320,840 2,398,154

GDP growth percent 5.8 5.1

International

merchandise trade

US$

million 2,476,427 2,510,127

Export US$

million 1,254,581 1,270,467

Import US$

million 1,221,847 1,239,660

Foreign direct

investments inflow

US$

million 114,082 119,756

Visitor arrivals thousand 89,225 -

Sources ASEANstats,

ASEAN Secretariat

Cross culture...

•Language: Tagalog, Bahasa Indonesia, Bahasa Malaysia, Thai, Vietnamese, Lao, Mynmar, Cambodia, English (commonly used language)

•Diverse culture;

•Timing: 2020 convergence of regulations

•Interests: Local, British, French, American,

Dutch, Portugese

•Local Government

Principles of ASEAN ECONOMIC COMMUNITY

FIGURE 1: POTENTIAL IMPACT OF AEC MEASURES ON THE GDP OF ASEAN MEMBER COUNTRIES (Cumulative percentage increase over baseline 2011-2015 in 2015)

Notes: Brunei is proxied by “Rest of South-East Asia” in the simulation. There are no estimates for Myanmar because of serious data problems Source: Mid-Term Review of the Implementation of AEC Blueprint: Executive Summary, October 2012, Eria; Itakura (2012).

According to the Economic Research Institute for Asean and East Asia (Eria) (2012) [3], the AEC, when it happens, can bring in substantial benefits to member countries. Some of the more substantial benefits will come from services trade liberations and improved trade facilitation, and not from the complete elimination of tariffs. As Figure 1 shows, a marked percentage jump in GDP growth has certainly occurred for Laos, Cambodia and Vietnam.

Source: AEC Scorecard, Asean Secretariat, 2012.

TABLE 1: AEC SCORECARD, 2008-2011 (% OF TARGETS ACHIEVED)

ACCSQ- MDPWG AGENDA

HARMONISATION

H A R M O N I S E D P R E M A R K E T

S U B M I S S I O N F O R M AT : A D O P T I O N O F T H E

C O M M O N S U B M I S S I O N D O S S I E R T E M P L AT E

S H A R I N G O F : P O S T M A R K E T S A F E T Y

I N F O R M AT I O N A M O N G A S E A N M E M B E R S TAT E S

H A R M O N I S E D S E T O F V O L U N TA R Y S TA N D A R D S I N A S E A N : B A S E D O N I E C A N D

I S O S TA N D A R D S

ASEAN Medical Device Directive

Agreed measures:

• Definition of medical devices

• Essential principles of safety and performance

• Risk classification rules

• Post-market vigilance and surveillance

ACCSQ-MDPWG

10

• Our accomplishment i. Developing a common submission dossier template for product approval

in ASEAN

Completed

ii. Exploring the feasibility of an abridged approval process for medical

devices which regulators of benchmarked countries or recognized

regulators have approved

Ongoing

iii. Exploring the feasibility of adopting a harmonized system of placement

of medical devices into the ASEAN markets, based on a common

product approval process i.e., AMDD

Ongoing

iv. Formalizing of a post-marketing alert system for defective or unsafe

medical devices.

Completed

v. All ASEAN countries to consider joining the Asian Harmonization

Working Party (AHWP) and work in parallel with the Global

Harmonization Task Force (GHTF) on technical harmonization efforts

Ongoing

What are requirements of AMDD?

Definition

Device Classification

Conformity Assessment

Product registration and placement in the market

Licensing of persons responsible

Technical Standards

Post market Vigilance and surveillance

Common Technical documents oCSDT

oPost Market Requirements

oDeclaration of Conformity

Countries with Legal Framework

Countries with Legal Framework

With Legal

Framework

Without Legal

Framework

NA

No of Countries 8 1 1

Member States Premarket Control Post market Comments

Establishment Product

Brunei N N Voluntary

Cambodia Y Y N

Indonesia Y Y Y

Laos Y N N Product

Registration in

Process

Myanmar N Y Y Regulate high risk

products

Malaysia Y Y Y

Philippines Y Y Y Mandatory

Product Recall

Reporting

Thailand Y Y Y

Singapore Y Y Y

Vietnam NA NA NA

What are being controlled?

Are we ready?

Transposition of

AMDD Y N Comments

No of MS which has

started the process

of transposition

2 8

No of MS which

will start after 1st

Jan 2015

6 1 1 country will

carry out

partial

transposition

Expected date for Mandatory

Enforcement of AMDD Expected date of

mandatory

implementation

No of Member States

Immediate 2

By 2017 1

Once the National Laws

are rectified 6

Progress of AMDD NO. STEPS TOWARDS

ENDORSEMENT AND

FINALISATION OF AMDD

ACTIONS TO BE TAKEN TIMEFRAME

1. Public Consultation by ASEAN

Member States

Member states to conduct Public

Consultation

October 2013

2. Amendments to AMDD Version

14 to incorporate comments

Special HOD Meeting in

Singapore to finalise AMDD

Version 14

November 2013

3. AMDD Version 15 to be

endorsed by ACCSQ.

ASEAN Secretariat to send AMDD

Version 15 to ACCSQ.

Endorsement through e-

communication by 1st

December 2013

4. AMDD Version 15 to be

endorsed by SEOM.

ASEAN Secretariat to send the

AMDD Version 15 to SEOM.

Endorsement at SEOM 1/45

Meeting in January 2014 in

Myanmar

5. AMDD to be signed ASEAN Secretariat to facilitate the

signing of the AMDD by the AEM

AEM Meeting at 25th ASEAN

Summit in August 2014

Progress of AMDD NO. STEPS TOWARDS

ENDORSEMENT AND

FINALISATION OF AMDD

ACTIONS TO BE TAKEN TIMEFRAME

1. Transposition of AMDD to

National Regulatory Framework

by Member States

Member states to carry out

rectification of current laws

Jan 2015

2. Formation of ASEAN Medical

Device Committee (AMDC) to

monitor and review progress of

transposition

Member states to formalise the

setting up of AMDC and

subsequently MDPWG ceased to

function

Jan 2015

3. Full transposition of AMDD in all

ASEAN Member States

Full implementation of AMDD by

ASEAN Member States

Jan 2020

What about Malaysia?

• 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,

decommissioning

Scope of Regulatory Framework

SURVEILLANCE & VIGILANCE

Establishments shall-

• monitor safety & performance

of their products

• carry out post-market

obligations, e.g user training,

complaint handling, FSCA,

recall

Authority allows -

• registered

medical devices

to be placed into

the market

• licensed

establishments

to do their

business

MEDICAL

DEVICES WILL BE MADE

AVAILABLE ON THE MARKET

Overview of The AMDD Regulatory Process

PRE-MARKET REVIEW

Manufacturers of medical

devices shall -

• ensure their products

conform to EPSP (Art. 3)

• ensure their products are

manufactured in accordance

with GMP

• collect evidence of

conformity

PRE-MARKET PLACEMENT ON-MARKET POST-MARKET

MEDICAL DEVICES

REGISTRATION &

LICENSING

• Establishment apply

for register medical

devices (Art. 6)

• Establishment apply

for establishment

license (Art. 7)

Authority monitors compliance to requirements & takes

appropriate actions in accordance with the provisions of the

law

Authority / Notified Bodies

verifies evidence of

conformity

Elements of CA

QMS (ISO 13485 or equivalent)

Post-market surveillance system (GHTF recommendations)

Summary technical documentation (ASEAN CSDT)

Declaration of conformity (DoC) (GHTF recommendations)

Quality Mgmt System (QMS)

• For manufacturer, ISO 13845 or equivalent

Declaration of

Conformity (DoC)

(Annex 6)

• A DoC is a declaration made by the manufacturer of a device that the device is in conformity with the regulatory requirements

• DoC declares that the manufacturer guarantees that each piece of the device sold is in conformity with the regulatory requirements

Summary Technical Documentation

(Annex 4)

• format –ASEAN CSDT

• Compliance to EPSP (GHTF recommendations - Essential Principles of Safety & Performance of Medical Devices) (Art. 3)

• Acceptable standards or equivalence will be widely used (Art. 9)(GHTF recommendations-Role of Standards in the Assessment of Medical Devices)

• Authority / Notified Bodies determines the adequacy of the documented evidence to support attestation of conformity

Post-Market Surveillance System

(PMS) (Annex 5)

Distribution records

Complaint records

Adverse incident reporting (GHTF recommendations - Medical Devices Post Market Surveillance: Global Guidance for Adverse Event Reporting for Medical Devices)

FSCA reporting (GHTF recommendations - Medical Devices Post Market Surveillance: Content of Field Safety Notices)

CONFORMITY ASSESSMENT SYSTEM OF AMDD FOR PRODUCT REGISTRATION

Challenges

• Language of AMDD

• How many Member States have

implemented the AMDD?

• What if member states are not ready with

rectification after 2015?

• Capacity Building

• PMS alert system

CAPACITY BUILDING of the AMDD

• Committed to implement AMDD - Ongoing activities to realize technical harmonization of MD regulations among ASEAN Member States

i. Training workshops in AMS targeted to assist local industry, understanding basics of MD regulations

ii. Regulator training – capacity building for AMS in collaboration with USAID

iii. Studying implementation details - ASEAN Single Window

iv. Studying implementation details - Registration using CSDT

23

Philippines

Mexico

Australia

CONCEPTUAL QUALITATIVE OVERVIEW OF CURRENT NATIONAL MEDICAL DEVICE REGULATORY SYSTEMS – TRENDS BY

ASEAN MEMBER STATES 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

Future ?

• A Common Submission Dossier format to be used

• Same Definition

• Common Classification rules

• Agreed Standards

• Acceptable Conformity Assessment

• Participation in post market vigilance and surveillance among member states

Thank You