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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

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Joaquin Lasso

Senior VP & GM Sports Medicine Intl《b r》Smith and Nephew
Board Sponsor
Sharad Mi. Shukla, Johnson & Johnson MedTech​

Sharad Mi. Shukla

Director Regulatory Affairs, MedTech (Lead APAC Digital Regulatory Policy & SEA Regulatory Affairs)​
Johnson & Johnson MedTech​
Regulatory Affairs Committee
Chairperson
Jason_Guo

Jason Guo

Regional RA Director, APAC
Abbott
Regulatory Affairs Committee
Vice-Chairperson
Renee Cotta, Boston Scientific

Renee Cotta

Senior Director Regulatory Affairs APAC
Boston Scientific
Regulatory Affairs Committee
Vice-Chairperson
Yasha Huang, Roche Diagnostics

Yasha Huang

Head of Regulatory Policy APAC
Roche Diagnostics
Regulatory Affairs Committee
Vice-Chairperson
cindy_pelou

Cindy Pelou

Lead, Regulatory Affairs
Secretariat Lead
Summer_new

Summer Tung

Project Manager, Regulatory Affairs
Secretariat

CHINA CENTRE OF EXCELLENCE (COE) MEMBERS: REGULATORY AFFAIRS

annie

Annie Yin

Vice President, Medical Regulatory Affairs
Roche Diagnostics
China Centre of Excellence
Chairperson
JinCui-2025

Jin (Jacqui) Cui

Director of Regulatory Affairs​
Abbott
China Centre of Excellence
Vice-Chairperson
Wang Ping

Wang Ping

RA Director​
ResMed
China Centre of Excellence
Vice-Chairperson
xws

Xiaowei Sun

Head of Regulatory Affairs, Greater China
Philips
China Centre of Excellence
Vice-Chairperson

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

Yu Hosokai, Cook Medical

Yu Hosokai

Senior Regulatory Affairs Manager – SEA, India, and IMM​
Cook Medical
Southeast Asia Centre of Excellence
Chairperson
Profile Picture

Chloe Tan

QARA Director, SEA
Medtronic
Southeast Asia Centre of Excellence
Vice-Chairperson
Khoo Kai Chang​, Johnson & Johnson MedTech

Khoo Kai Chang

MedTech Regulatory Affairs Lead (Singapore), SEA Orthopaedic Portfolio Lead​
​Johnson & Johnson​ MedTech
Southeast Asia Centre of Excellence
Vice-Chairperson
Mandy Tam, Carl Zeiss Vision

Mandy Tam

VTS RA Manager, APAC
Carl Zeiss Vision
Southeast Asia Centre of Excellence
Vice-Chairperson

INDIA CENTRE OF EXCELLENCE (COE) MEMBERS: REGULATORY AFFAIRS

Aaditya_revised

Aaditya Vats

DIRECTOR, REGULATORY AFFAIRS AND QUALITY ASSURANCE
TERUMO INDIA PRIVATE LIMITED
Indian Subcontinent Centre of Excellence
Chairperson
lipi

Lipi Chakhaiyar

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

Kulveen Singh Bali

DIRECTOR, REGULATORY AFFAIRS - ISC
PHILIPS
Indian Subcontinent Centre of Excellence
Vice-Chairperson
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Prashanth Prabhakar

Head - Regulatory Affairs
Boston Scientific India
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
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