WG8 Standards | ||
|---|---|---|
| Chair: |
Email: idamazura@mda.gov.my | Regulatory Authority |
| Co-Chair: | Mr. Tony LOW 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 | Regulatory Authority |
| Member: | Mr. Sung Wook CHOO Assistant Director MFDS Republic of Korea | Regulatory Authority |
| Member: | Sameer A. Al- Hamdan Head of products registration support Medical Device Sector Saudi Food and Drug Authority Kingdom of Saudi Arabia | Regulatory Authority |
| Member: | Ms. Jaleela ALjulandany Biomedical Engineer Ministry of Health Sultanate of Oman | Regulatory Authority |
| Member: | Dr. Madoka Murakami Principal Reviewer, Office of Software as a Medical Device Pharmaceuticals and Medical Devices Agency (PMDA) Japan | Regulatory Authority |
| Member: | Dr. Tetsuya Kusakabe International Coordination Office Pharmaceuticals and Medical Devices Agnecu (PMDA) Japan | Regulatory Authority |
| Member: | Dr. Guohui Jiao Reviewer Center for Medical Device Evaluation NMPA People's Republic of China | Regulatory Authority |
| Member: | Dr. Jia Zheng Deputy Director of Division National Institutes for Food and Drug Control NMPA People's Republic of China | Regulatory Authority |
| Member: | Dr. Lina Wei Assistant Research Fellow Institute for Medical Device Control National Institutes for Food and Drug Control NMPA People's Republic of China | Regulatory Authority |
| Member: | Mr. Edinanth Gareba Medical Devices Officer Tanzania Medicines and Medical Devices Authority (TMDA) Tanzania | Regulatory Authority |
| Member: | Ms. Yadira Alvarez Rodríguez Regulatory Policy Specialist CECMED Cuba | 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: | Ms. Yidong ZHANG Regulatory Affairs Manager Medtronic People's Republic of China | Industry |
| Member: | Mr. Hideki Asai Senior Fellow MED MIRAI Inc. Japan | Industry |
| Member: | Mr. Chuan Qin Senior regulatory affairs manager GE Healthcare People's Republic of China | Industry |
| Member: | Ms. Qian Dong Head of Regulatory Intelligence, APAC Align Technology People's Republic of China | Industry |
| Member: | Dr. Yi Tian Principal Key Expert and Head of CT Concepts Siemens Shanghai Medical Equipment Ltd People's Republic of China | Industry |