On May 15, 2019, more than 300 scientists as well as representatives of the medical device industry and governmental agencies convened at the Chinese International Medical Equipment Fair (CMEF Spring 2019) in Shanghai for the “2nd Sino-US Summit Forum of Medical Device Total Product Life Cycle (TPLC) Risk Assessment - Studies on Safety Assurance and Risk Assessment of Active Implanted Devices Medical". The summit – hosted by the Shanghai Society of Biomedical Engineering – was co-organized by the Shanghai Municipal Medical Product Administration, the Shanghai Testing & Inspection Institute for Medical Devices, the University of Houston, Texas, and the IT’IS Foundation.
At the summit, opinion leaders and high-ranking speakers from China, the US, and Europe reviewed and discussed how safety assurance and risk assessment of implantable medical devices are currently performed in China. They also presented and compared national regulations to international standards and procedures worldwide and provided an outlook on methodologies and solutions for future regulation. IT'IS director Niels Kuster and recent PhD graduate Aiping Yao presented recent results on the risk assessment of active medical implants in magnetic resonance imaging in fields of up to 14T, with overviews of state-of-the-art instrumentation and procedures for evaluation of medical devices.
An important outcome of the many presentations and discussions is that computational modeling and simulation and the ability to appropriately validate the corresponding results is increasingly being viewed by the U.S. Food and Drug Administration (FDA) as key contributions to the evaluation of the safety and effectiveness of medical devices. Computational science already plays an essential role in a large number of medical device approval requests submitted to the FDA and may play a similar role in the Chinese regulation process in the future.