Pudong advances towards world-class medical device cluster

​Liu Lizheng (left), head of humanoid robot projects at Shanghai's Fudan University, and his colleagues pose with the Guanghua No 1 humanoid robot, which was developed by his team for elderly health care scenarios, on May 14. [Photo by Gao Erqiang/China Daily]

Pudong New Area has transitioned from following global trends to leading innovation in high-end medical devices, fueled by a robust ecosystem spanning basic research, incubation, clinical translation, and industrial application.

The district has approved over 1,200 Class III medical device registration certificates, accounting for 40 percent of Shanghai's total. Among these, 38 are innovative medical device licenses, representing 60 percent of the city's total and 10 percent of China's total.

Five new innovative devices were approved this year alone, underscoring an acceleration in cutting-edge product launches. Pudong now leads in six key sectors, including vitro diagnostics, brain-computer interfaces, and medical robots.

Wei Junjing, vice president of the Shanghai Association of Food & Drug Safety, said that domestic companies have progressed from catching up to leading in technology, aided by Pudong's pilot reforms in regulatory systems.

The district hosts over 500 medical device research and development enterprises, with top global device giants maintaining a presence alongside homegrown leaders such as Endovastec, Kinetic Medical, and iRay.

It aims to strengthen innovation sourcing, optimize spatial layouts, and foster international growth under the three-year plan released in October.

In terms of spatial layout level, the district will continue to leverage the advantages of the Zhangjiang biomedical industrial hub, coordinate the construction of smart manufacturing spaces and the renewal of existing facilities, and guarantee space for high-quality projects.

This aims to further reduce the comprehensive operational costs for enterprises, encouraging more marketing authorization holders for products under research to establish their production bases in Pudong New Area.