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Date, time & venue
2017-03-03;13:30 - 17:30;Theatre 1, HKPC Building, 78 Tat Chee Avenue, Kowloon, Hong Kong
Supported by HKIE-ITD
Programme Highlights
This training course offers golden opportunity for various stakeholders related to medical and healthcare device industries to keep abreast of the latest regulatory requirements, as well as to make better strategy and business planning. Details are as follows:
- Opening Speech by AHWP Chair - Dr Hee-Kyo Jeong
Director General, Medical Device Evaluation Department, MFDS, Republic of Korea
- HKPC One-stop Service in Biomedical Engineering - Ir Bryan So
Principal Consultant, Biomedical, Optical & Precision Engineering, HKPC, HKSAR
- Updates on Clinical Evaluation for IVD Devices - Dr Petra K aars-Wiele
Senior Director International Regulatory, Quality & Labeling, Abbott Laboratories, Germany
- Updates on Standards for Software as a Medical Device - Ir Dr Peter Linders
Director, Standards & Regulations Global Quality & Regulatory, Philips Healthcare, Netherlands
- Updates on ISO 13485:2016 - Mr Grant Ramaley
Convener, Medical Device Working Group for ISO 13485, International Accreditation Forum
- Updates by APACMed on Medical Device Regulatory Harmonization - Ms Tran Quan
Vice President, Regulatory Affairs, APACMed, Singapore
- Regulatory Updates on Medical Device in China - Ms Huang Jin
Vice Secretary-General, Shenzhen Association of Medical Devices (SAMD), the PRC
- Regulatory Updates on Medical Device in Hong Kong - Ir Jennifer Mak
Senior Electronics Engineer, Medical Device Control Office, Department of Health, HKSAR
- Regulatory Updates on Medical Device in Kingdom of Saudi Arabia - Mr Ali M.Al-Dalaan
Executive Director, Medical Device Sector, Saudi Food and Drug Authority, Kingdom of Saudi Arabia
- Regulatory Requirements on Clinical Investigation for Medical Device in Korea - Mr Se-il Park
Assistant Director, Division of Hightech Medical Devices, MFDS, Republic of Korea
- Updates on ASEAN Medical Device Directive - Mr Alfred Kwek
Regional Director, Government Affairs/HME, Samsung Electronics, Singapore
Medium
English
Registration and Enquiries
Registration Fee: HKD500. Supporting Organization’s member can enjoy 10% off of the training fee. Please complete the Enrollment Form in BLOCK LETTERS and submit together with programme fee before programme commencement. Enrolment Deadline : 24 February 2017.
For enquiries, please contact Mr. Bill YEUNG at Tel: (852) 2788 5869 Fax: (852) 2788 5405 E-mail: billyeung@hkpc.org.
Report
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