Work Group 8 (WG8) - Standards

Submitted by admin on Fri, 06/02/2017 - 16:52
Chair:

Mrs. Salbiah BT Yaakop
Director of Policy, International Affairs & Industry Facilitation Division
Medical Device Authority
Ministry of Health
Malaysia

Email: salbiah@mda.gov.my

 Regulatory Authority
Co-Chair:

Mr. Tony LOW
Director of Human Performance and Medical QA/RA
Commissioning Agents International (CAI)

Email: tonylow.iso@gmail.com 

 Industry
Secretary:  Mr. Muhammad Marwan Bin Anoor
Assistant Director of Policy, International Affairs & Industry Facilitation Division 
Medical Devices Authority 
Ministry of Health
Malaysia
Regulatory Authority
Advisor: Dr. Gert W. BOS  
Member: Mr. Sung Wook CHOO
Assistant Director
MFDS
Republic of Korea
Regulatory Authority
Member:

Eng. Abdullah Mohammed Alghuraibi
Manager, Regulation and Registration
Support Department
Medical Device Sector
SFDA

Regulatory Authority
Member: Sameer A. Al- Hamdan
Head of products registration support
Medical Device Sector
SFDA
Regulatory Authority
Member: Eng. Osamah Mohammed Nasser Al Barikan
Senior Standards & Regulations Specialist
Saudi Food and Drug Authority
Kingdom of Saudi Arabia
Regulatory Authority
Member: Mr. Scott COLBURN
Director, CDRH Standards & Conformity Assessment Program / S-CAP
US Food & Drug Administration
USA
Regulatory Authority
Member: Ms. Jaleela ALjulandany
Biomedical Engineer
Ministry of Health
Sultanate of Oman
Regulatory Authority
Member: Mr. Rajaram BALASUBRAMANIAN
Director - QA & RA
Elekta Medical Systems (India) Limited
Tamilnadu, India
Industry
Member: Ms. Ade Herawati PURNAMASARI
Regulatory Affairs Leader – Indonesia
PT GE OPERATIONS
Indonesia
Industry
Member: Ms. Lesley TAN
Technical Consultant
UL International (S) Pte Ltd
Singapore
Industry
Member: Ms. Latika Vats
Director
Regulatory Affairs & Quality Assurance
Terumo India Private Limited
India
Industry
Member: Mr. Kim Euncheol
Researcher
Medical Device Information & Technology 
Assistance Center
Republic of Korea
Industry
Member: Dr. Young Huh
Program Director
Korea Evaluation Institute of Industrial Technology
Republic of Korea
Industry
Member: Mr. Fang Zhou FENG
International RA Supervisor
Shanghai Kinetic Medical Co., Ltd
People's Republic of China
Industry
Member: Dr. Christopher Chan
SEQPRO, Inc, Taiwan
Industry
Member: Mr. Ee Bin Liew
Owner
Access-2-Healthcare
Singapore
Industry
Member: Gonzalez Y. Esteban
L.A. Regulatory Affiars & Quality Compliance Manager
Health Care Division
3M
Chile
Industry
Member:

Ir Prof. K.F. Albert Poon
Hospital Engineering Consultant
Hong Kong SAR, China

Industry
Member: Ms Sara Mohamed
Regulatory Affair Manager
Dentsply Sirona Malaysia Sdn Bhd
Malaysia
Industry
Member:

Mr. Raghavan Nair Asok Kumar
Director
Abbott Healthcare Private Limited
India

Industry
Member: Dr. Sadanand Gite
Associate Director
Regulatory Affairs Strategic Programs
Abbott 
USA
Industry
Member: Ms. Yidong ZHANG
Regulatory Affairs Manager
Medtronic
People's Republic of China
Industry