17th ASEAN
Consultative Committee on
Standards & Quality
- Medical Device
Product Working Group
(ACCSQ-MDPWG)
UPDATES from MLIG-SMF
May Ng
Awareness Seminar for Medical Device
III (15 May 2013)
Organised by:
Supported by:
Copyright 2013, by May Ng
CONTENT
Background of ASEAN & ACCSQ-MDPWG
17th ACCSQ-MDPWG Meeting
- Pre-meeting training (for regulators by US-TATF)
- Medical Device Industry seminar (Malaysia)
- Country updates in Public-Private Forum
- 10th ACCSQ-MDPWG Technical Committee Meeting Report
- 17th ACCSQ-MDPWG Meeting Report
Copyright 2013, by May Ng
CONTENT
Background of ASEAN & ACCSQ-MDPWG
17th ACCSQ-MDPWG Meeting
- Pre-meeting training (for regulators by US-TATF)
- Medical Device Industry seminar (Malaysia)
- Country updates in Public-Private Forum
- 10th ACCSQ-MDPWG Technical Committee Meeting Report
- 17th ACCSQ-MDPWG Meeting Report
Copyright 2013, by May Ng
ASSOCIATION OF
SOUTHEAST ASIAN
NATIONS
 10 countries
(Singapore, Malaysia,
Thailand, Brunei, Indonesia,
Philippines,
Cambodia, Laos, Myanmar,
Vietnam)
 ASEAN Land Area: 4,464,322
sq km
 ASEAN Population: 564,986,000
Copyright 2013, by May Ng
ASEAN Economic Community (AEC)
& ACCSQ-MDPWG
ASEAN Summit
ASEAN Economic Ministers Meeting (AEM)
ASEAN Senior Economic Officials Meeting (SEOM)
Dec 97 ASEAN Vision 2020
Oct 03 AEC 2020
Jan 07 AEC 2015
(a)
(b)
(c)
(d)
Single Market & Production Base eg Free flow
Competitive Economic Region eg IP
Equitable Economic Development eg IAI
Integration into the Global Economy eg IBP
ASEAN Consultative Committee on Standards and
Quality (ACCSQ) since 1992
• Medical Device Product Working Group
(MDPWG) since 3 - 4 Aug 2004
• Pharmaceutical Product Working Group (PPWG)
• Traditional Medicines and Health Supplements
Product Working Group (PPWG)
• ASEAN Cosmetics Committee (ACC)







Healthcare & e-ASEAN sectors
Wood-based product & Automotives
Rubber-based products & Textiles & apparels
Agro-based products & Fisheries
Electronics
Air Travel & Tourism
Logistics
Copyright 2013, by May Ng 5
ASEAN Medical Device Directive
ACCSQ-MDPWG Aim:
• To standardize the regulatory framework for regulating medical device
among member states, with a set of principles in the AMDD.
• AMDD will help improve patient safety standards across the region and
ensuring citizens of each of the ASEAN Member States have timely access to
safe and effective medical devices, as well as providing a more
straightforward path to market in the region for manufacturers of medical
devices.
• AMDD targeted for implementation by Dec 2014.
Philosophies tools from the Global Harmonization Task Force
Copyright 2013, by May Ng 6
ASEAN Medical Device Directive
Article 1 General provisions
Article 2 Definition and scope of medical device
Article 3 Essential principles of safety and
performance of medical device
Article 4 Classification of medical devices
Article 5 Conformity assessment
Article 6 Registration and placement on the market
Article 7 Registration of persons responsible for
placing medical devices on the markets of member
states
Article 8 Technical documents for medical devices
Article 9 Reference to standards and relevant
documents
Article 10 Labelling
Article 11 Product claims
Article 12 Post-marketing alert system
Article 13 Clinical investigation
Article 14 Institutional arrangements
Article 15 Safe guard clauses
Article 16 Confidentiality
Article 17 Special cases
Article 18 Implementation
Article 19 Dispute Settlement
Article 20 Final provisions
Annex 1 Essential Principles of Safety and
Performance of Medical Devices
Annex 2 Risk Classification Rules for Medical
Devices other than in-vitro diagnostic products
Annex 3 Risk Classification Rules for In-Vitro
Diagnostic Products
Annex 4 ASEAN Common Submission Dossier
Template (CSDT)
Annex 5 Post Marketing Alerts System (PMAS)
Requirements
Annex 6 Harmonized set of elements for a Product
Owner’s or Physical Manufacturer’s Declaration of
Conformity (DoC)
Annex 7 Component Elements of a “Dear Healthcare
Professional” Letter
Annex 8 Sample Template of Letter of Authorisation
Annex 9 Labelling Requirements
Annex 10 Clinical Investigation – Pre-market Clinical
Investigation to Support Marketing Authorisation
Application
AMDD Version 11,
Draft for National consultation, 8 May 12.
Copyright 2013, by May Ng 7
CONTENT
Background of ASEAN & ACCSQ-MDPWG
17th ACCSQ-MDPWG Meeting
- Pre-meeting training (for regulators by US-TATF)
- Medical Device Industry seminar (Malaysia)
- Country updates in Public-Private Forum
- 10th ACCSQ-MDPWG Technical Committee Meeting Report
- 17th ACCSQ-MDPWG Meeting Report
Copyright 2013, by May Ng 8
S/N
1
AGENDA ITEMS
ADOPTION OF AGENDA
DISCUSSED ITEMS
• Annex 1 List of delegates
• Annex 2 Provisional annotated agenda
2
3
BUSINESS ARRANGEMENT
UPDATES ON THE RECENT
DEVELOPMENTS IN ASEAN
ECONOMIC INTEGRATION
INITIATIVES
~
• ASEAN harmonization is on technical requirements in ASEAN
countries. It is not a single approval for ASEAN market.
MATTERS ARISING FROM THE
16th MDPWG MEETING
• Annex 5 MDPWG 16th Meeting on follow-up actions taken
4
• SEOM, AEC Deliverables for 2015 (ie 2013)
• AEM, AMDD 2015 implementation roadmap
• AEM, Non-Tariff measures in ASEAN Trade in Goods Agmt
(ATIGA), AMS feedback if impacted AMDD.
• Annex 3 AEC deliverables for 2015
• Annex 4 AEC deliverables for 2013
Copyright 2013, by May Ng
S/N
AGENDA ITEMS
DISCUSSED ITEMS
5
DEVELOPMENT OF THE ASEAN MEDICAL DEVICE DIRECTIVE
5.1
AMDD Finalization
5.2
Risk Classification of MD Guidelines
• Annex 10 Risk classification, feedback by 30 Jun 13
5.3
Agreement on a Framework for
Disseminating and Sharing of Information
Relating to Adverse Events Associated with
Medical Devices among ASEAN Member
States
• Annex 11 Agreement, AMS to comment after
AMDD legal scrubbed.
•AMDD legal scrubbing & endorsement (see table)
• AMDD public consultation - categorised as
AMDD legal scrub by AMS
31 May 13 recommendations (excl. LOA, Dear HCP letter)
AMDD legal scrub by Alegal
1 Jun 13 clarifications, general or personal and typos.
AMDD endorse by ACCSQ
4-5 Jul 13 • IMDRF changes will be revised to AMDD if impacted
AMDD endorse by SEOM
16 Sep 13 patient safety
th
• Annex 6 AMDD
AMDD endorse in ASEAN Summit
24
• Annex 7 AMDD public consultation presentation
• Annex 8 Country updates to AMDD and timeline
• Annex 9 AMDD roadmap's priority activities
• CLMV under Initiative for ASEAN Integration (IAI)
• AFMDI, entity associated with ASEAN ie ID, MY, PH,
SG, TH & soon VN
Copyright 2013, by May Ng
S/N
6
AGENDA ITEMS
8th MEDICAL DEVICE
TECHNICAL COMMITTEE
REPORT
DISCUSSED ITEMS
• ACSDT implementation in AMS (see table)
• Standards, final feedback from TH & VN by 3 May 2013
• Post market activities
Annex 12 AE form
Annex 13 FSCA form
Annex 14 8th MD Technical Committee report
ACSDT
Singapore Since 2010
Indonesia Since 2010 (partial English & local language)
Thailand Since 2012 (partial English & local language)
Cambodia Targeted 2013
Malaysia Targeted Jul 2013
PhilippinesTargeted end 2013
Brunei
Not yet
Laos
Not yet
7
7.1
NEW AREAS
Refurbished Medical Devices
7.2
In-vitro Diagnostic Medical
Devices (IVDs)
• ACSDT IVD differ from MD on the pre-clinical testing,
feedback by 30 June 2013
8
NOMENCLATURE OF MEDICAL
DEVICES
• Annex 17 Nomenclatures by MIMOS. Noted GMDN, UMDNS,
SNOMED, ICD-10, LOINC correlated. Continue to share
eg ID using HS code in INSW, TH not yet
• Malaysia's GRPMD based on COCIR, JIRA and MITA sharing
• PH guide in progress SG allowed and ID not regulated.
Copyright 2013, by May Ng
S/N
9
9.1
AGENDA ITEMS
DISCUSSED ITEMS
COOPERATION WITH INTERNATIONAL AND REGIONAL ORGANISATIONS
• Annex 18 IMDRF 3rd meeting (5 GHTF, Brazil, Canada, AHWP
Cooperation with the IMDRF
affiliated organization, Russia and Mexico observer) - NCAR,
UDI, SAP, Std, Pdt Submission. IMDRF 12-14 Nov 13 Brussels.
9.2
Cooperation with WHO
• Continue follow-up regional office of WHO SEARO-WPR,
WHO-US
10
Technical assistance and
cooperation with dialogue
partners
• Annex 19 Concept note on US-funded training
prioritized based on AMDD roadmap
- Indonesia (26-27 Aug regulators & 28-29 Industry)
- Thailand (21-23 Aug regulators & industry, ie CLM)
-Vietnam (late Jul regulators & industry)
11
OTHER MATTERS
• MDPWG Trust Fund closure, after funded Myanmar
delegates to 16th meeting.
12
WORK PROGRAMME
Annex 20 MDPWG Work programme
13
NEXT MEETING
Annex 21 MDPWG List of Meetings
14
ADOPTION OF REPORT
Adopted for next meeting in October, Brunei.
Copyright 2013, by May Ng
CONTENT
Background of ASEAN & ACCSQ-MDPWG
17th ACCSQ-MDPWG Meeting
- Pre-meeting training (for regulators by US-TATF)
- Medical Device Industry seminar (Malaysia)
- Country updates in Public-Private Forum
- 10th ACCSQ-MDPWG Technical Committee Meeting Report
- 17th ACCSQ-MDPWG Meeting Report
Excl.
Copyright 2013, by May Ng
Philippines
Regulatory Authority
Center for Device Regulation, Radiation Health, and Research (CDRRHR)
Food and Drug Administration, Department of Health
MD regulation
•
•
•
•
Republik Act 3720 in June 1963, 'Food, Drug and Cosmetic Act' - regulated
manufacture and distribution of food, drugs and cosmetics
Executive Order No. 175 amended RA3720, add regulation of MD to BFAD
Executive Order No. 102, created BHDT but not enacted to regulated MD
Republic Act No. 9711 in Aug 2009 created FDA, DOH strengthen
regulatory in food, drug, cosmetics, MD and other health devices (BFAD &
BHDT in FDA)
Copyright 2013, by May Ng
Philippines
Regulatory control
1) Establishment License
• Manufacturer, Distributor/importer, Distributor/wholesaler, Retailer
• Leadtime : 90 days ie inspection
2) Product registration
• Class 1, 2, 3,4; per product/brand/model excl. size and shape
• Leadtime: 180 days
• e-copy dossier and hardcopy returning for co. record since 2011
3) AE & Recall reporting
4) PMS
Copyright 2013, by May Ng
Philippines
Class 1
Class 2
Class 3
Class 4
Legal requirements
• Application form, notarized
• Medical device establishment license issued by the CDRRHR
• Agreement with licensed local manufacturer and distributor, notarized
• Registration of product issued by the health authority from the country of origin and foreign agency agreement, both
notarized and duly authenticated by the Philippine Consulate (for imported product)
Technical Requirements, based on the ACSDT
•Device description
•Description of the sterilization method and the packaging used, the sterility level and the validation of the sterilization process
(if applicable)
•Certificate of Conformity to the aspect of manufacture relating to metrology for devices with measuring functions
•Declaration of Conformity with product standards (if applicable)
•Sample of labels on the device and its packaging and other labeling materials to be used for the device that includes user’s
or instruction manuals
•Government certificate attesting to the status of the Manufacturer ‘s competency and reliability of the personnel and
facilities or QS Certificate of approval or compliance certificate with ISO 9000 series or ISO 13485. (for imported product,
Certificate to be duly authenticated by the territorial Philippine Consulate)
•Stability studies (if applicable)
•Picture of the product and representative sample or commercial presentation of the product (when needed)
•Executive Summary
•Relevant essential principles and method/s used to demonstrate conformity (if applicable
•Device description*
•Design Verification and Validation Documents*
•Risk assessment consisting of risk analysis, evaluation and reduction measures, (if applicable)*
•Manufacturer information including the process, quality assurance*
•Clinical evidence (if applicable)*
•Software validation studies (if applicable)
•Biological evaluation (if applicable)*
* varies depend on device class
•List of countries where the
device has been soldCopyright 2013, by May Ng
Thailand
Regulatory Authority
Medical Devices Control Division, Food and Drug Administration
MD regulation
•
•
•
•
Drug Act, bfr 1988
Medical Device Act 1988 & MDCD, FDA since June 1990
Ministerial Notification: Requiements on recording & reporting of
manufacturing/importing/selling of MD, 7 June 2011
Ministerial Regulations & FDA notifications: Application & Issuing of
Manufacturing/Importing MD Licenses & Notifications (CSDT), 28 May
2012
Copyright 2013, by May Ng
Thailand
Regulatory control
1) Establishment License
• Manufacturing, Importing
• Leadtime : 90 days ie inspection
2) Selling Licence (some device)
• Licensed (condoms, surgical gloves, HIV IVD, contact lens ie cosmetic use, blood
bag ie with anti-coagulant); Notified (physical therapy, alcohol detector, breast
implants, breast enhancer external use, etc); General
• Class 1, 2, 3,4
Leadtime: 180 days, per product/brand/model excl. size and shape
3) Post-Marketing - check premises, sampling, vigilance, AE,
One Stop Service Center – Pre-market, pre-advertisement, cert issuance;
One Stop Complaint Center – Post- market, post-advertisement, enforcement
Network of control - provincial, port, police, lab/standard, healthcare
professional/expertise
Copyright 2013, by May Ng
Thailand
Regulatory control - updates
• MD definition ie animal use, IVD, software, accessories, components or parts,
any announced by minister
• MD reclassification
• National single window/licence per invoice (targeted Sep/Dec 2013)
• Database: Importer Co. Reg. No. ID code, Product License/Notification/Import
permit letter No., HS code, Product code, City & Country of Origin
• Outsource program
• AMDD & AEC 2015
Copyright 2013, by May Ng
Indonesia
Regulatory Authority
Medical Device Production and Distribution Service, Pharmaceutical &
Medical Device Service, MOH
MD regulation and policy
•
•
•
•
•
•
•
Act on health
Gov regulation
Production, Distribution, registration of medical devices & household
National Medical Device Policy
Product under regulation - Premarket control & Postmarket control
Use under Health Technology Management - Assessment, Procurement,
User, Maintenance
Risk based, ASEAN harmonization, International std, transparency &
excellent service reformation
Copyright 2013, by May Ng
Indonesia
Regulatory control
Pre-market control
•CSDT, QMS ISO 13485 , National & International Std
•Registration no., product name, product generic name, type/size (all accessories
in attached licence), Manufacturer name & Address, Distributor name & address,
HS code, release date, expired date, country of origin,
•Validity 5 years
Post-market control
•Sampling, monitoring production and distribution facilities to QS standard,
vigilance eg AE report, PMS (MOH with civil police investigator working with
healthcare facilities, police, customs, health province officer
Copyright 2013, by May Ng
e-Monitoring
Indonesia
e-Registration
(http://regalkes.depkes.go.id)
- Registration no.
- Production License
- Distributor License (GDP)
Indonesia National Single Window
(http://eservice.insw.go.id)
National system that integrates all entities which
related to customs clearance to accelerate the
process of import-export services and traffic.
- National Trade Repository
- Single sign on
e-Planning
e-Catalogue
(http://inaproc.lkpp.go.id/v3/public/ekatalog/ek
atalog.htm)
- Government procurement for goods and
services, President decree No. 70/2012
- transparent, accountable, effective, efficient,
decrease MD less 40%, decrease healthcare
expenditure f0or Social Security program &
MDGs
- Name, type, specification, price , service
guarantee
Copyright 2013, by M
Regulatory Authority
Lao PDR
Drug Control Division, Food and Drug Department, MOH
MD regulation and policy
•
•
•
•
•
•
The National Drug Policy was endorsed in 1993, and revised in 2003
Drug and Medical Product Law enacted since April 2000, 2nd and ie risk
class A,B,C,D, endorsed by National Assembly last year (2012)
Regulation regarding drug and medical product company
establishment No. 1442 dated 13 August 2003 (Importer or
Distributor authorization)
Supervision and monitoring tools based on the Good Wholesaling Practice
(GWP)
Regulatory control
•
MD control committee, AMDD, guideline in progress, MD list and it use in
health care facility has been established by Medical Product Supply Centre
with FDD; Medical equipments in central and provincial hospitals in ID
Copyright 2013, by May Ng
system
Cambodia
Regulatory Authority
Medical Device Section, Registration Bureau, Department of Drugs, Food, Cosmetics
and Medical Devices, MOH
MD regulation and policy
•
•
•
•
•
•
•
•
Constitution of the Kingdom of Cambodia
Reach Kret No ns/rkt 0908/1055 dated 25 September 2008 establishing the Royal
Government of Cambodia.
Reach Kram No ns/rkm/ 0196/06 dated 24 January 1996 establishing the MOH
Reach Kram No Cs/rkm/ 0696/02 approval of the Drug law dated 17 June 1996
Sub‐Decree No 67 GnRk/kt dated 22 October 1997 empowering the Ministry of
Health to undertake activities related to Health Service.
Sub‐Decree No 44 GnRk/kt dated 10 August 1994 Pharmaceutical Registration
Prakas No 145 Gbs dated 14 / 03 / 2001 consumable device registration
Prakas No Gbs dated 2000 reagent registration
Copyright 2013, by May Ng
Regulatory control
•
•
•
Cambodia
Flow: Licensing of Manufacturer, importer; Product registration no.; Imported license of
registered products
Process: submit dossier, evaluation and computerised system, complete document, payment,
passed committe meeting, licensing.
new regulation Nov 2012: definition, 4 classes, CSDT (excl. Class A)
Class A
‐ Application form
‐ GMP or ISO Certificate (ISO 13485)
‐ FSC issued by Health Authority
‐ Letter of Authorization
Class B, C and D
‐ Application form
‐ GMP or ISO Certificate (ISO 13485)
‐ FSC issued by Health Authority
‐ Letter of Authorization
- Registration Certificates in other countries (if available)
‐ Testing Report
‐ Technical documents: CSDT (requirement increase with risk)
Leadtime: 90 days,
Validity: 3 years
renewal 6mths bfr expired.
Copyright 2013, by May Ng
Regulatory Authority
Brunei
Healthcare Technology Department , MOH
MD regulation and legal framework
Legal
Framework
•
•
•
Drafting MD regulations & policies
Voluntary implementation to be carry out
No mandatory control
Regulatory control – Premarket & Postmarket
Technical
capacity
Building
Medical
device
Regulation
Pre-market
control
Post-market
control
Pre-market control
• Business Establishment Licensing
• Development of QMS certification procedures, specifications and guidance
• Product registration
• AMDD technical requirements, ACSDT
Post-market control
• MDPWG forms and develop procedures and forms, strengthen surveillance
Copyright 2013, by May Ng
Regulatory Authority
Malaysia
Medical Device Authority, MOH
MD regulation and policy
•
•
•
•
•
•
•
Medical device regulatory program proposal approval by Cabinet, 16 Feb 2005
Medical Devices Control Division established in Aug 2005, for MD bill and legislation,
program, registration & surveillance/vigilance system
MEDICAL DEVICE AUTHORITY ACT 2012 (ACT 738), Gazetted 9 Feb 2012 & Effective 15
Mar 2012
MEDICAL DEVICE ACT 2012 (ACT 737), Gazetted 9 Feb 2012 & Effective 30 Jun 2013
MEDICAL DEVICE REGULATIONS 2012, Gazetted Dec 2012 & Effective 1 Jul 2013
Orders, other legislative tool
- Permit for designated medical device
- Others to be determined, post market requirements, advertising and usage (ie
maintenance, installation, T&C and disposal)
Guidance Documents, Standards
Device definition..i(b) any instrument, apparatus, implement, machine, appliance, implant,
in-vitro reagent or calibrator, software, material or other similar or related article, to be used
on the human body, which the Minister may, after taking into consideration issues of public
safety, public health or public risk, declare to be a MEDICAL DEVICE by order published in the
Copyright 2013, by May Ng
Gazette.
Act & Regulations
(ACT 737 - 6 Parts, 80 Sections)
Part I : Preliminary
Part II: Registration of Medical Device and
Conformity Assessment Body
Chapter 1: Registration of medical device
Chapter 2: Registration of conformity
assessment body
Part III: Licence and Permit
Chapter 1: Establishment licence
Chapter 2: Designated medical device
permit
Chapter 3: Duties and obligations of
licensees or permit holders
Chapter 4: General duty
Chapter 5: Export permit
Part IV: Appeal
Part V: Enforcement
Malaysia
(MDR 2012 - 14 Parts, 61 Sections)
Part I : Preliminary
Part II: Conformity Assessment Procedures
Part III: Registration of Medical Device
Part IV: Registration of Conformity Assessment
Body
Part V: Establishment Licence
Part VI: Export Permit
Part VII: Labelling Requirements
Part VII: Duties and Obligation of Licensees
Part IX: Exemption of any person or medical
device from any provision of this Act
Part X: Usage, Operation, Maintenance
Part XI: Requirements for provision of auditing,
consulting or Training related to medical device
regulatory matters
Part XII: Appeal
Part XIII: Register
Part XIV: Prescribed fees
Copyright 2013, by May Ng
Act & Regulations timeline
Cabinet
approve
d
proposal
to
develop
MD
regulator
y system
16 Feb05
Medical
Device
Control
Division
establishe
d
09 Feb12
Act 737.
Act 738
gazetted
Act 738
comes into
operation
09 Feb12
15
Mar12
Medical Device Control
Division (MDCD)
Appointment
of members of
the Authority
Malaysia
Medical
Device
Authority
(MDA)
establishe
d
Medical
Device
Regulations
(MDR) 2012
gazetted
14 Jun12
31 Dec12
Act 737
comes into
operation
30 Jun13
Effective
date of
MDR 2012
Enforcem
ent of
establish
ment
license
Enforce
ment of
medical
device
registrati
on
30
Jun14
30
Jun15
01
Jul13
Medical Device Authority
(MDA)
Cessation
of MDCD
Transition –
establishment license
Transition –
MD registration
Act 737 Part VI: General, Section 80: Savings and transitional
– 80(1): A person who has imported, exported or place in the market any medical device prior to appointed date of the Act
shall apply for registration of medical device within 24 months from the appointed date
– 80(2): A person who has imported, exported or place in the market any medical device and intend to continue shall apply for
establishment licence within 12 months from the appointed date
– 80(3): A person in 80(1) or 80(2) may continue to import, export or place in the market the medical device pending
determination of application
Copyright 2013, by May Ng
CAB verifies evidence of conformity
PRE-MARKET ASSESSMENT
Manufacturers of medical devices shall • ensure their products conform to Essential Principles for Safety
& Performance (EPSP) of Medical Device
• establish appropriate quality system for manufacturing
• collect evidence of conformity
MEDICAL DEVICE
REGISTRATION
• Manufacturer (or authorized
representative) apply to
register medical devices &
establishment license
ESTABLISHMENT
LICENSING
• Importers/distributors shall
ensure compliance to GDP &
advertising requirements
• apply for establishment
license to import/distribute
medical devices
MDA issues licenses, registers medical devices
and monitors compliance to requirements & takes
appropriate actions in accordance with the law
SURVEILLANCE &
VIGILANCE
• Establishments
shall monitor
safety &
performance of
products
• carry out postmarket obligations,
eg complaint
handling, FSCA,
recall
USAGE &
MAINTENANCE
• Users shall use,
maintain & dispose
off medical devices
appropriately
• Users shall apply
for permit to
use/operate
designated
medical devices
Copyright 2013, by May Ng
THANK YOU
Acknowledgement to:
BIOSENSORS INTERNATIONAL GROUP
SINGAPORE HQ
•
Health Products Act - www.agc.gov.sg
•
Global Harmonization Task Force (GHTF) - www.ghtf.org
•
Asian Harmonization Working Party (AHWP) - www.asiahwp.org
•
ACCSQ Medical Device Product Working Group - www.accsq-mdpwg.org
Copyright 2013, by May Ng