09 Oct 2010
A Seminar on "Medical Devices Regulatory"

The Biomedical Engineering Laboratory of the University of Macau (UM), Macau Society of BioMedical Engineering (MSBME) jointly organize, with supports of IEEE University of Macau Student Branch, UMSU and IEEE Macau, a seminar "Medical Devices Regulatory" was held on 8th October 2010 at Auditorium II, Library of University of Macau.

The seminar was delivered by Mr. Jack Wong. Mr. Wong is the Vice President of Regulatory Affairs, Asia, and General Manager, Hong Kong of British Standards Institution Product Services. He has over 14 years of regulatory, clinical trial and pharmacovigilence experience in Asia with good knowledge in the field of cancer products, pharmaceuticals, nutritional products, medical devices, consumer healthcare and biological. He managed 400 medical devices and 215 pharmaceutical registration projects with 32 regulatory related staff and consultants in 18 countries of Asia with budget of US$1million. Direct reports including 12 Regulatory staff range from senior assistant to managerial level. He externally plays a leading role among all the regional regulatory professionals in AHWP (Asian Harmonization Working Party), and was invited to provide regulatory training in local universities and industry organizations.

This workshop is to share among the new knowledge area of medical devices regulatory which is positively forecasted for a very big demand in the future. The definition of medical device was firstly given followed by the method of classification. Two main organizations of the regulatory for Global and Asia, GHTF and AHWP were then introduced, and the regulatory and regulatory trend of Global and Asia devices were also covered. Finally the seminar ends after the introduction of Basic 9000 and 13485. The participants of this seminar are over 40 Macau engineers and FST students.


The audiences at the seminar at the University of Macau
 
 

Speaker Mr. Jack Wong, the Vice President of Regulatory Affairs, Asia, and General Manager, Hong Kong of British Standards Institution Product Services.