SHANGHAI, July 29, 2019 /PRNewswire/ -- The MDiT Forum and Regulation Summit, which is widely regarded by registration, quality, compliance, medical, and R&D departments as well as project/enterprise heads, will be held as scheduled during Medtec China 2019, from September 25 to 27, 2019 in Shanghai. Many invitees of the following authoritative organizations have already confirmed their attendance at the conference as guest speakers: U.S. Food and Drug Administration (FDA), National Institutes for Food and Drug Control (NIFDC) Biomaterials and Tissue Engineering Office, Instrumentation Technology and Economy Institute, P.R. China (ITEI) Medical Device Reliability Lab, Institute of Die & Mould, Dalian University of Technology, Center of Biomedical Materials & Tissue Engineering, Academy for Advanced Interdisciplinary Studies, Peking University, and Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. Conference registration is ongoing, and early-bird rates are closing in 3 days. For more information about conference registration, please CLICK HERE.
FDA allies with NIFDC and other authorities to cover Chinese and foreign regulatory updates
"Chinese Regulatory Updates and Compliance" is designed to provide interpretations of the latest Chinese regulations and standards, and coping strategies and recommendations. This year Mr. Feng Xiaoming, deputy director of Biomaterials and Tissue Engineering Office, NIFDC, will give an exclusive interpretation on the registration of innovative medical devices. At the Quality Track B: Latest MDSAP Developments and FDA Factory Inspection, Medtec China is honored to have once again invited Mr. Bill Sutton, assistant director of the FDA China Office, and Mr. Yu Zeli from RAC Global to jointly present a lecture. Mr. Sutton will share the latest data on MDSAP, including MDSAP report exposability and FDA's upgrades to the MDSAP, as well as two parts applicable to ISO 13485. Mr. Yu then will analyze the impact of FDA policy changes on factory inspection in 2019, and to conclude the main points of FDA factory inspection and factory experience of MDSAP in 2018–2019.
Concerns to risk management of medical products, leading the development trend of implanted & interventional medical devices (IIMD)
The quality track A is "Risk Management of Medical Product Life Cycle", Mr. Jiang Hua, director of Tianjin Medical Device Quality Supervision and Inspection Center, China Food and Drug Administration (CFDA), will analyze biological evaluation and testing based on the risk management process; Mr. Shao Linyun, deputy director of the Central R&D Management Department of Shenzhen Mindray, will discuss on how to conduct reliability-oriented medical device quality management from the perspective of device makers.
IIMD China Summit will once again return to Medtec China 2019. Xi Tingfei, director of Center of Biomedical Materials & Tissue Engineering, Academy for Advanced Interdisciplinary Studies, Peking University, has been invited to present analysis on the new development trends of the IIMD industry, and share the latest regulations and technologies on the cardiovascular system. Last year, as the world's first drug balloon for coronary artery bifurcation lesions - "Qingzhou" drug balloon appeared on the market, and generated considerable interest. Dong Heyan, president and technical director of Yinyi (Liaoning) Biotech Co., Ltd. will share details of the design technology and the R&D process on the summit. For more details, please click HERE, early-bird rates closing in 3 days, saving you up to 2200 yuan.
Medtec China 2019 will take place from 25th to 27th September in Shanghai. A smorgasbord collecting education, business, information, and resources for the medical industry now awaits the joining of professionals. Click here to pre-register as visitor now.
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SOURCE Medtec China