自贸区医疗器械注册人制度助力产业化 - 2019年01月25日

A 3D-printed custom knee-joint orthosis, developed by a research team of Shanghai Ninth People’s Hospital affiliated to Shanghai Jiao Tong University School of Medicine, was approved by the FDA and put into use recently.
The Class II medical device, developed by the research team led by academician Dai Kerong and director Wang Jinwu, can offer more accurate and efficient medical treatment.
It is the first time that a scientific research institute has obtained the medical device registration certification since the Medical Device Registrant System was piloted within the Shanghai Free Trade Zone on December 1, 2017.