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BIOMEDICAL
Technical Seminar on Micro-fabrication Technology to Support the Development of the Miniaturisation of Medical Devices and Rehabilitation Engineering and the Application of Diffusion Bonding and 3D-Keltool Technologies in Medical Device Components Manufac
By Mr Bryan M K SO

A seminar on Micro-fabrication Technology to Support the Development of the Miniaturisation of Medical Devices and Rehabilitation Engineering and the Application of Diffusion Bonding and 3D-Keltool Technologies in Medical Device Components Manufacturing was organised by the BM Division in late October 2004, at Hong Kong Productivity Council (HKPC). The seminar with two sections was conducted by Ir Derek C H Louie and Mr Kenneth D H Yuen of HKPC. During the seminar, Ir Louie explained the vast demand for the development of biomedical and medical micro electrical and mechanical system (MEMS), and miniaturised instruments, and their related targeted applications and great commercial potential for solving existing problems encountered in the medical and biomedical field. He also introduced several micro-fabrication technologies, including multi-axis single point diamond machining, micro-EDM, micro-injection moulding, ultra-precision hot embossing and micro laser application, which facilitate the fabrication of non-silicon-based MEMS. The technology on fabricating micro-channels on the non-silicon miniature substrate of the micro pump by using ultra-precision hot embossing technology was also illustrated and explained in particular. The second section was conducted by Mr Yuen, who shared with the participants in details on two manufacturing technologies, namely the 3D-Keltool and diffusion bonding. Mr Yuen explained their theories behind as well as applications in practice, he also shared with the participants on how these two technologies might suit for medical device manufacturing.



Ir Derek Louie, Principle Consultant of HKPC, was presenting the topic on micro-fabrication technology


Participants were listening to the presentation

Technical Seminar on International Regulatory Overview on Medical Device Approval
By Mr Bryan M K SO

A seminar on International Regulatory Overview on Medical Device Approval was jointly organised by the BM Division and the Hong Kong Medical and Healthcare Device Manufacturers Association on 12 November 2004, Friday, at Hong Kong Productivity Council (HKPC). The seminar was conducted by Dr Theobald S K Chan, Consultant of HKPC. During the seminar, Dr Chan introduced various regulatory issues including the product classification, types of pre-marketing regulatory assessment: product listing, US 510(k) and PMA clearance, EU CE-marking, PRC product registration, clinical evaluation, use of international and national standards and product testing, role of quality systems (medical device GMP) in medical device regulation and the roadmap of product approval process. Dr Chan explained that one of the characteristics for medical device manufacturing distinguished from other consumer product manufacturing, was the stringent regulatory control that covers from the initial technology design all the way through end-product distribution to the target market. Despite Global Harmonization Task Force, composing regulatory bodies and industry representatives from five major medical device markets, has been actively working on international harmonisation of regulation for more than a decade, only aspects of regulatory harmonisation have been achieved so far. To successfully walk through the regulatory mazes was still a prerequisite for medical device manufacturers and R&D personnel to introduce new products or technologies in different markets. With more than 40 participants taken part, the seminar also provided an overview on the regulatory systems of three major medical device markets, namely the USA, Europe and the PRC, with particular emphasis on the roadmap and required resources, that R&D personnel and manufacturers have to consider when planning a new project.


Dr Theobald Chan, Consultant of HKPC was presenting to the participants of the seminar


Dr Theobald Chan, Consultant of HKPC was presenting to the participants of the seminar

CPD Seminar on the Medical Device Administrative Control System of Hong Kong
By Mr Bryan M K SO

A seminar on the Medical Device Administrative Control System of Hong Kong was jointly organised by the BM Division and the Hong Kong Medical and Healthcare Device Manufacturers Association on 10 December 2004. After the public consultation on the regulation of medical devices conducted in 2003, the Government proposed to implement a Medical Device Administrative Control System (MDACS) as a transitional measure to pave the way for smooth transition to the succeeding statutory regulation. The MDACS was developed based on the recommendations of the Global Harmonization Task Force (GHTF). Two draft documents, namely Overview of the Medical Device Administrative Control System (Guidance Notes: GN-01) and Guidance Notes for Listing Class IV Medical Devices (Guidance Notes: GN-02), setting out the framework of the proposed system respectively and the detailed requirements for listing high risk devices were issued in June 2004 for the public to comment. According to the plan of the Government, the system will be implemented by phases. The first phase, that was voluntary listing of Class IV Medical Devices, was scheduled to be launched by the Department of Health before the end of 2004.

The seminar was conducted by Mr Mark W K Lau, Senior Electronics Engineer of the Electrical and Mechanical Services Department, the HKSAR. Mr Lau explained the MDACS, its objectives, principles, scope of control, classification method of medical devices, etc during the seminar which attracted more than 30 participants. The two-hour seminar adjourned at 4:00pm. Presentation material of the seminar can be found at the website of the Department of Health, the HKSAR at http://www.info.gov.hk/dh/useful/meddev/seminar.htm for reference.


Mr Bryan So, Honorary Secretary of the BM Division, presented a souvenir to the seminar speaker Mr Mark Lau, Senior Electronics Engineer of the Electrical and Mechanical Services Department, the HKSAR


Participants were listening to the presentation by Mr Mark Lau at the HKIE

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