SHANGHAI, Aug. 27, 2013 /PRNewswire/ -- MEDTEC China 2013 would not be the same without its traditional co-located on-site conference and once again this year, it welcomes a top-class event: the MDiT Forum and Regulation Summit 2013. The organizers are happy to announce that the schedule is now very close to being finalized. The three-day multi-module event starts one day before the MEDTEC China 2013 show itself commences. Mark September 24, 2013 down in your diaries; the date when the summit kicks off!
MDiT Forum and Regulation Summit 2013 program highlights
Day 0 (September 24, 2013)
Heading up the summit on Day 1 are two parallel modules, commencing at 13:30: Module A: Chinese Regulatory Updates and Implementation and Module B: Design and Innovations.
Module A will kick off with a presentation from Yutao Hua, Division Chief, Chemical medicine and medical device division, National Center for Biotechnology Development, Ministry of Science and Technology of PRC entitled "Current situation analysis and future trend of medical device industry in China." With this keynote as a starting point, three focused presentations will follow addressing such issues as registration and regulations for medical devices (Shanghai Food and Drug Administration), GMP implementation of medical device (SFDA), and new regulations for medical devices and their impact on medical device manufacturers (Shanghai Food and Drug Administration).
The parallel session on Design and Innovations will feature a number of topics of interest headed by a sponsored presentation from Filtrona Porous Technologies covering "High Absorbent Super Soft Hydrophilic Polyurethane Foams for Advanced Wound Care and other Medical Foam Applications" by Dr. Chandrasiri Jayakody, Director of Research & Development-Foam Technologies. This will be followed by papers entitled "Innovating with quality: a new theme in medical device development" (Medical Implant Mechanics), "Design and Innovation of Spine Implant Devices" (Bonovo Orthopedics), and "Innovation of material: research, production and application of new biomedical coating material" (Shanghai Institute of Ceramics Chinese Academy of Science).
Day 1 (September 25, 2013)
Day 2 of the conference also features an afternoon start, with Module C focusing on Overseas Regulatory Updates and Market Access. This track will start with an "FDA update: application of Unique Device Identifier (UDI) in the whole medical device industry" by Lane Arbittier, Quality Assurance & Regulatory Affairs Expert from Zimmer. Following this are presentations on "Submission of pre-market approval (PMA) for Class III medical device," "EU regulatory: In Vitro Diagnostic Medical Devices (IVD) regulations and European market access" (ACIDIM Association/Synergus AB), and "The application of RAPS (Regulatory Affairs Professionals Society) in medical device industry" (Medtronic China).
Concurrently, Module D, Wireless/Mobile Medical, begins with a presentation entitled "Development of Wireless/Tele/Mobile Medical in US & EU and exploring the opportunity in Chinese market" (ZEVC). The session will then move on to papers on "Mobile Health, from Sensor to Cloud" (Shenzhen Institutes of Advanced Technology, Chinese Academy of Sciences), "Specific application of tele medical and its development trend" (General Hospital of Chinese People's Liberation Army), and "Technique requirement and standardization trend of wireless/mobile medical" (China National Institute of Standardization).
Day 2 (September 26, 2013)
The final day of the conference features a morning start (09:00), with two modules once again running in parallel. Heading up Module E: Clinical Trial of Medical Devices is the opening presentation from Dr. Liang Qian, Regional Lead & Orthopedics Expert, British Standard Association entitled "Clinical data requirement for EU high-risk medical products." Dr. Liang's presentation is augmented by three others by Chinese speakers, including "Challenges of clinical trial for medical device: application of statistic" (Wei Li, Director & Professor, Director for National Center for Fuwai Cardiovascular Diseases China), "Exploring solutions for clinical trial of medical devices according to Provisions for Medical Device Classification published by SFDA," and "Case Study: clinical trial of bioabsorbable vascular stent" (Dr. Guixin Shi, R&D Director, Beijing Advanced Medical Technologies).
In parallel once again is Module F: Risk Management & Quality Control. The first presentation in this session is "How local manufacturers establish concrete compliance evidence to satisfy FDA QSIT inspection" (Scott Yu, an independent regulatory consultant). Following on are presentations on "Safety evaluation of new type biomaterial and quality control of medical devices" (National Institutes for Food and Drug Control), "Risk analysis techniques and methodology for medical device and how to apply them to control product quality" (a sponsor presentation by Pacific Bridge Medical), and a second presentation from Lane Arbittier, QA & RA Expert in Zimmer entitled "Implementing ISO13485: Quality Management Systems effectively and understanding the new standards from US & EU regulatory bodies."
With such a strong program, the organizers anticipate intense interest from show visitors in all of these modules. For this reason, they suggest that show attendees planning on participating in the conference turn up early and secure their seats. The organizers look forward to welcoming all attendees to the MDiT Forum and Regulation Summit 2013. Please click here for detailed event agenda.
For more information about the MEDTEC China exhibition and conference, please visit www.medtecchina.com.
About the Organisers
A World Leader in Medical Device Communications
UBM Canon, the leading B-to-B media company dedicated exclusively to the global $3 trillion advanced manufacturing sector and part of the UBM Group, helps support the flow of information, commerce and innovation in sophisticated segments such as medical devices and pharmaceutical development. UBM Canon also addresses cutting-edge developments in broader areas of advanced engineering design and manufacturing including manufacturing processes and packaging.
UBM Canon's portfolio of events for the healthcare manufacturing sectors includes MD&M, MEDTEC, BIOMEDevice, and Pharmapack. UBM Canon also publishes a multitude of industry magazines, including Medical Device and Diagnostic Industry, Medical Product Manufacturing News, European Medical Device Technology, China Medical Device Manufacturer and Japan Medical Design & Manufacturing Technology. With this unique media portfolio, UBM Canon is able to connect over 3,500 medical device industry suppliers with more than 100,000 design and manufacturing professionals every year.
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SOURCE MEDTEC China