HKSTP organized a seminar named “Medical
Device Regulatory Affairs and Quality Assurance” on 25 April 2016. This seminar is set to tackle the
increasingly complicated International, Asian and European medical device
regulations and quality requirements. The
seminar aims to share knowledge on medical devices regulations in major
jurisdictions such as US, Europe, ASEAN and Hong Kong, as well as how to
maintain and apply them and avoid the pitfalls form both practical and academic
perspectives. I took a photo with Prof. Albert
Poon at the end of seminar for memory.
Prof. Albert Poon (Professor of
Practice (Biomedical Engineering), Interdisciplinary Division of Biomedical
Engineering, Faculty of Engineering, PolyU; Associate Specialist, Medical
Device Program of SGS Academy) was the first speaker and his topic entitled “Medical
Device Regulation and Life Cycle Management”.
Prof. Poon said the figures in the left hand side of the first slide
demonstrated today’s topics included Regulations (FDA, CE), Hong Kong Medical
Device Regulation Choice and Design Control which followed US or EU in R&D
area.
