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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
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