Shanghai unveils blueprint to fast-track medical devices by 2027

by YANGSHU Hongji

Shanghai has unveiled a blueprint to boost its high-end medical device industry, a 55.5-billion-yuan (about US$7.8 billion) sector that makes up more than a quarter of the city's biopharma economy. By 2027, the city aims to secure over 500 new Class III approvals - China's highest-risk devices such as implants and life-supporting equipment - obtain 100 overseas approvals and nurture at least two local firms each generating over 10 billion yuan (about US$1.4 billion) in output.

The "Action Plan for Promoting the Full-Chain Development of the High-End Medical Device Industry in Shanghai", released on Sept.15, highlights regulatory measures to ease market entry. Shanghai will encourage multinationals to produce imported Class II and III devices locally and pilot overseas-approved devices in Shanghai before national registration. Reviews will be faster and more products eligible for fast-track approval.

Payment reform is another focus. Innovative devices outside China's bulk procurement system can be listed directly and purchased by hospitals through negotiated prices. Insurance authorities will broaden reimbursement channels and test cost-sharing with public and private insurers, drugmakers and charities. Reimbursement is seen as the "last mile" for innovative devices to reach patients and become commercially viable.

The blueprint also prioritizes frontier technologies such as brain-computer interfaces, AI applications and integrated diagnostic-therapy systems. To support this, Shanghai plans to boost R&D in core components, expand clinical research and promote M&A to consolidate the sector, while universities and research institutes will be tasked with training cross-disciplinary MedTech talent.

Growth will center on three clusters: Pudong in the east, already hosting multinationals and MedTech hubs; Jiading in the northwest, building a base for precision equipment and diagnostics; and Minhang in the southwest, focusing on advanced devices and components. officials said the strategy is to integrate research, product development, clinical trials and manufacturing into a unified system, part of Shanghai's bid to become a global hub for advanced medical devices.