SYNOPSIS

Medical Device Authority (MDA) Malaysia’s main objective is to protect the public health and safety. MDA strives to ensure that medical devices in Malaysia are of high quality, effective and safe. In this half a day seminar, the government officials will share with us our role in contributing to the quality of the healthcare system in the country. The session ends with a presentation on the latest updates of IEC 60364-7-710 Ed2:2018 Electrical installations of buildings - Part 7-710: Requirements for special installations or locations - Medical locations. Do take this opportunity to join this seminar to find out more on the topics being delivered customized personally for members of the Institution of Engineers Malaysia.    

SPEAKERS’ PROFILE

Ir. Sasikala Devi A/P Thangavelu holds a Bachelor of Engineering (Electrical) from University Technology Malaysia in 1983, Master of Science in Biomedical Engineering, Keele University, United Kingdom and she is currently pursuing her PhD (part time) in Biomedical Engineering in Plymouth University, United Kingdom.  She is a professional engineer with 33 years of experience in serving Malaysian public in various sectors.  She is currently the Director of Policy, Code and Standard, Medical Device Authority, Ministry of Health.
She is also an affiliate member of Board of Engineers Malaysia, Institute of Engineers, Malaysia, IEEE Engineering in Medicine and Biology Society, IMDRD AE WG, Malaysia Medical Device Professional Association (MMDPA, TC10 Committee Code of Practice of Active Medical Devices, Permanent Member representing Ministry of Health, Malaysia, TC2 Committee Disposal Medical Devices, SIRIM Permanent Member representing Ministry of Health, Malaysia, Single use devices(SUD) Committee, Medical Device Authority(Chair), Policy Development on Medical Devices Regulatory Control Committee, Medical Device Authority, Certification Advisory Committee (CAC) of SIRIM QAS International and Drug Advertisement Board, Ministry of Health Malaysia.

Puan Salbiah Binti Yaakop graduated with a BSc in Biomedical Engineering from Marquette University, USA in 1992.  In total, she has more than 27 years of working experience.  She is currently the Senior Principal Assistant Director in the Policy, Codes and Standards Division of Medical Device Authority.  Here, her main functions are development of policies, guidance documents, guidelines, regulatory documents; managing international affairs and inter-agency agenda, industry assistance, events and specific projects: performing registration and licensing evaluations and verifications; and giving trainings and consultancy.
She is currently the Chairperson of various Guidance Document Development Committees in Medical Device Authority, and AHWP WG & Chair on Standards for Medical Devices.  She is also a member of various Industry Standards Committees, Technical Committees and Working Groups related to medical devices in the national standards system.

Puan Norshafina Binti Sahinin graduated from Universiti Putra Malaysia, Serdang,  Bachelor of Science (Hons)-Physics.  She has 4 years’ experience in handling and monitoring establishment’s medical device complaint, especially complaint related to medical device safety and performance.  Also active as a speaker for awareness program at all healthcare facilities and related agencies.
She is currently Assistant Director at Medical Device Authority.  Active Malaysia representative for APEC Harmonization Center (AHC) medical Device Vigilance Workshop that held annually for Asia Pacific Regulator Bodies and medical device industries.

Ir. Lim Kim Ten (K.T. Lim) graduated with B.E (Hons) from University of Malaya (1979) and M.Sc. (Electrical) from National University of Singapore (1990). He has extensive experiences in low voltage electrical installations of buildings, industrial electrical and electronic engineering, healthcare facilities, oil and gas industries and technical lecturing.
He is actively involved in Malaysian electrical and electronic engineering such as member of MyENC (Malaysian National Electrotechnical Committee), committee members in electrical and electronic standard writing committees in the field of electrical installations, power quality, protection and insulation, medical gas and healthcare facilities, and industrial advisory panel to universities. Moreover, Ir. K.T. Lim is actively involved in electronics, control systems and PCB design engineering, as speaker in conferences, course instructor in specialized industrial electrical and electronic engineering and active member of engineering committees such as:

• Admission and Professional Training, IEM;
• Engineering Competency Development (Formerly Logbook Training Scheme), IEM;
• Examination and Qualification, IEM;
• Professional Interview Board, IEM;
• Membership Application Board, IEM;
• Professional Interview Board, IEM;
• Training Board, TEEAM.
• Competency Board, Medical Device Authority (MDA)


In cooperation with Medical Device Authority, Ministry Of Health Malaysia