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(Supported Event) Asian Harmonization Working Party (AHWP) Workshop on Medical Device Regulation & Regulatory Harmonization

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 

Details please refer to the electronic flyer



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:





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