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Regulatory Affairs

navigating the increasingly complex and fragmented regulatory landscape

APACMed’s Regulatory Affairs Committee is the Association’s largest committee, counting over 450 dynamic and engaged senior regulatory professionals.

Part of the impetus behind the creation of the APACMed in 2014, was the need to help MedTech industry navigate the increasingly complex and fragmented regulatory landscape. APACMed provides access to actionable regulatory intelligence for its members, advocates for harmonised regulatory requirements where possible across Asia Pacific countries through capacity building and best practice sharing, and promotes regional and global convergence by securing a seat at the table with key harmonisation platforms, building thought leadership in prioritized areas, as well as fostering long-term partnership with regulatory authorities, peer associations, academia and industry.

APACMed’s Regulatory Affairs Committee is the Association’s largest committee, counting over 450 dynamic and engaged senior regulatory professionals.

Much of the regulatory advocacy efforts across the region coalesce around in market based Centres of Excellence, covering: China, South Korea, South East Asia, and  India. Separate Regional Working Groups are dedicated to Regulatory Intelligence (RI), Digital Health (DH), Capacity Building Group (CBG), and In-Vitro Diagnostics (IVD). Through its Centres of Excellence and Working Groups, APACMed has successfully engaged members and fostered its networks at the local level across the region

APACMED RA VISION AND STRATEGIC PILLARS

Spearheading regulatory excellence for optimised patient access to medical technologies, in close collaboration with regulators, policy makers, peers in other regions and others.

HARMONISATION

Promote regulatory convergence and harmonisation to reduce market entry complexities​

CAPABILITY BUILDING

Elevate the industry regulatory capabilities, ensuring professionals possess comprehensive skills to promote standardised excellence in regulatory affairs.

AGILITY

Advocate for flexibility to accommodate emerging innovative technologies and advancements​

INTELLIGENCE

Provide timely insights, foster proactive industry engagement, and promote collaborative dialogue between regulators and manufacturers to enhance regulatory intelligence.

Regulatory Intelligence

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digital health regulations

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in vitro diagnostics regulations

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capability building group

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in-country advocacy work

India centre of excellence (CoE)

other countries

OUR LEADERSHIP TEAM

Paul_Tan

Paul Tan Minjie

Divisional Vice President, APAC
Abbott
Board Sponsor
miang2-01

Miang Tanakasemsub

Head of Regulatory Affairs (RA), Asia Pacific (AP)
Johnson & Johnson Vision
Regulatory Affairs Committee Chairperson
James Chan

James Chan

Regulatory Affairs Director, APAC
Varian Medical Systems (a Siemens Healthineers company)
Regulatory Affairs Committee Vice-Chairperson
Jason_Guo

Jason Guo

APAC Director, Regulatory Affairs, Quality and Compliance
Abbott
Regulatory Affairs Committee Vice-Chairperson
MarrianeYap

Marianne Yap

VICE PRESIDENT, QUALITY, REGULATORY AND GOVERNMENT AFFAIRS
ASIA PACIFIC, CHINA AND JAPAN
ALCON
Regulatory Affairs Committee Vice-Chairperson
yasha2

Yasha Huang

Head of Regulatory Policy Asia Pacific Global Regulatory Policy & Intelligence
Roche Diagnostics
Regulatory Affairs Committee Vice-Chairperson

CHINA CENTRE OF EXCELLENCE (COE) MEMBERS: REGULATORY AFFAIRS

annie

Annie (Qiman) Yin

Vice President Medical Regulatory Affairs
Roche Diagnostics (Shanghai) Limited
China Centre of Excellence Chairperson
Jacqui Cui

Jacqui Cui

Regulatory Affairs Director Global Strategic Regulatory Abbott Quality and Regulatory
Abbott Laboratories
China Centre of Excellence Vice-Chairperson
Wang Ping

Wang Ping

Senior Regulatory Affairs Manager
Resmed china
China Centre of Excellence Vice-Chairperson
kenmeng

Meng Qinghai (Ken)

Associate Director Regulatory Affairs
Baxter China
China Centre of Excellence Vice-Chairperson

SOUTHEAST ASIA CENTRE OF EXCELLENCE (COE) MEMBERS: REGULATORY AFFAIRS

Sharad-Shukla_revisedv2

Sharad Shukla

HEAD, REGULATORY AFFAIRS,
JOHNSON & JOHNSON MEDTECH
Southeast Asia Centre of Excellence Group Chairperson
Yenny_Angorro

Yenny Anggoro

Director – RA & QA
Stryker ASEAN
Southeast Asia Centre of Excellence Vice-Chairperson
Yu_Hosokai

Yu Hosokai

REGULATORY AFFAIRS MANAGER - SEA
COOK SOUTH EAST ASIA
Southeast Asia Centre of Excellence
Vice-Chairperson
Profile Picture

Chloe Tan

QA & RA Lead,
Indochina and Frontier Market Plus,
MEDTRONIC
Southeast Asia Centre of Excellence
Secretary

INDIA CENTRE OF EXCELLENCE (COE) MEMBERS: REGULATORY AFFAIRS

Parveen Jain

Parveen Jain

Head- Regulatory, Quality and Government Affairs, South Asia
Fresenius Medical Care
Indian Subcontinent Centre of Excellence
Chairperson
PP Image (1)

Prashanth Prabhakar

Head - Regulatory Affairs
Boston Scientific India
Indian Subcontinent Centre of Excellence
Vice-Chairperson
lipi

Lipi Chakhaiyar

Director Regulatory Affairs, India and South Asia
Abbott (Medical Device Division)
Indian Subcontinent Centre of Excellence
Vice-Chairperson
Aaditya_revised

Aaditya Vats

ASSOCIATE DIRECTOR, REGULATORY AFFAIRS,
JOHNSON & JOHNSON
Indian Subcontinent Centre of Excellence
Vice-Chairperson

KOREA CENTRE OF EXCELLENCE (COE) MEMBERS: REGULATORY AFFAIRS

Leslie_Kim

Leslie Kim

RAQA DIRECTOR
STRYKER EAST ASIA
Korea Centre of Excellence Chairperson
Justin_Yea2

Justin Yea

Senior QRA Program Manager
Medtronic
Korea Centre of Excellence Vice-Chairperson
JiyoungAhn_rev

Jiyoung Ahn

Head of Regulatory Affairs,
Boston Scientific Korea
Korea Centre of Excellence Vice-Chairperson
Lena_Kim2

Lena Kim

RA Director
Cook Medical
Korea Center of Excellence Secretary

REGULATORY INTELLIGENCE (WG)

Shivkumar_Hurdale

Shivkumar Hurdale

Senior Director – RA & QA, APAC
Stryker Asia Pacific
Regulatory Intelligence Working Group
Chairperson
crystalJingNie

Crystal (Nie Jing)

Director Regulatory Affairs & Regulatory Compliance (China),
Microvention-Terumo
Regulatory Intelligence Working Group
Vice-Chairperson
Muhammad_Sohail

Muhammad Sohail

Manager – RA & Pharmacovigilance QREM
Fresenius Medical Care, Pakistan
Regulatory Intelligence Working Group
Secretary

IN-VITRO DIAGNOSTICS (WG)

Bivash

Bivash Chakraborty

Head – Regulatory Affairs & Quality & Government Affairs – South Asia
Biomerieux India Ptd Ltd
In-Vitro Diagnostics Working Group Chairperson
Chrissy Huang

Chrissy Huang

Head of Regulatory Affairs, Emerging Market
Ascensia
In-Vitro Diagnostics Working Group Vice-Chairperson
Fadzlon

Fadzlon Yunos

Senior Executive, Regulatory Affairs
Beckton Dickinson
In-Vitro Diagnostics Working Group Secretary

CAPACITY AND CAPABILITY BUILDING (WG)

YitingCai_v2

Yiting Cai

REGIONAL REGULATORY AFFAIRS DIRECTOR,
ALCON ASIA PACIFIC
Capacity & Capability Building Working Group Chairperson
winggangseet-01

Wing Gang Seet

Director, Regulatory Affairs, APAC,
Cook Medical
Capacity & Capability Building Working Group Vice-Chairperson

REGULATORY DIGITAL

manancrop

Manan Hathi

Sr. Manager, Regulatory Affairs, Software
Stryker Corporation
Regulatory Digital Chairperson
estella

Soeun Park (Estella)

Regulatory Affairs Lead, Korea
Philips
Regulatory Digital Vice-Chairperson
Dacia Su

Dacia Su

Regulatory Affairs Director, Asia
embecta
Regulatory Digital Vice-Chairperson Secretary
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