Action Plan of Shanghai Municipality on Promoting the Full-Chain Development of High-End Medical Device Industry

This Action Plan is formulated to promote the high-quality development of Shanghai's high-end medical device industry and build a high-end medical device industry hub with greater global influence.

I. Main Objectives

By 2027, over 500 Class III medical device registration certificates will be newly approved for the Chinese mainland market, and over 100 new medical device products will be approved for overseas markets. Two leading enterprises, each with an annual output value exceeding 10 billion yuan and robust international competitiveness, will be cultivated. Additionally, three high-end medical device industry clusters will be established.

II. Key Products for Development

1. Advanced medical imaging products. Accelerate the iterative development and upgrade of high-performance medical imaging products, such as positron emission tomography (PET) and X-ray computed tomography (CT) scanners, as well as high-definition angiography equipment. Promote the research and development of compact home-use ultrasound devices.

2. Advanced implantable products and interventional products. Accelerate the iterative development and upgrade of innovative products, including absorbable vascular stents and new orthopedic implants, and facilitate the development of products such as intravascular piezoelectric guidewire systems and cardiac function improvement counterpulsation systems.

3. Advanced surgical system. Accelerate the iterative development and upgrade of high-performance surgical systems such as endoscopic surgery robots, and promote the research and development of next-generation surgical systems such as flexible surgery robots.

4. Advanced in-vitro diagnostic products. Accelerate the iterative development and upgrade of new high-throughput sequencers, new chemiluminescent diagnostic equipment and reagents, and other automated medical diagnostic equipment and reagents, and promote the research and development of molecular diagnostic equipment and reagents based on new disease diagnostic markers, and in-vitro diagnostic products such as home-use non-invasive blood glucose monitoring systems.

5. Advanced radiation therapy products. Accelerate the iterative development and upgrade of products such as proton therapy systems and boron neutron capture therapy equipment, and advance the research and development of innovative solutions such as flash radiotherapy equipment.

6. Advanced rehabilitation therapy products. Accelerate the iterative development and upgrade of rehabilitation products, such as rehabilitation robots and exoskeleton robots capable of real-time monitoring of patients' motor and cognitive states, and promote the research and development of products such as invasive/semi-invasive brain-computer interfaces for high-resolution neural signal analysis.

7. Advanced artificial intelligence medical devices. Accelerate the iterative development and upgrade of products such as intelligent medical imaging diagnostic software and surgical navigation systems, and promote the research and development of medical intelligent agents and embodied medical intelligent robots.

8. Future innovative devices. Accelerate the research and development of future therapeutic products such as micro-nano robots for precise diagnosis and treatment, future diagnostic and therapeutic products based on technologies such as quantum and nucleic acid mass spectrometry, and brain-like intelligence products.

III. Key Tasks

1. Enhancing the Capacity for Innovation Origination

(1) Strengthening basic research and address key problems in cutting-edge technologies. Strengthen research on precision diagnosis and interventional therapy for tumors, neural function regulation, and related fields. Accelerate the development of imaging technologies such as multiplex Raman spectroscopy imaging and spinal cord/brain ultrasound functional imaging, brain-computer interface technologies including high-precision EEG signal decoding and high-density microelectrode arrays, and integrated diagnosis and treatment technologies such as image-guided accelerator systems. (Responsible unit: the Municipal Commission of Science and Technology)

(2) Accelerating the research and development of key material devices and the development of core production processes. Advance the development of key materials such as crystal materials for high-performance imaging equipment and nickel-titanium materials for pan-vascular implants. Accelerate the development of high-end tubes for medical imaging equipment and ultra-flexible electrodes for brain-computer interfaces. Promote the optimization and improvement of core processes such as packaging of high-performance endoscope core components and high-end balloon forming for cardiovascular interventions. (Responsible units: the Municipal Commission of Science and Technology, and the the Municipal Commission of Economy and Informatization)

(3) Accelerating the development and application of artificial intelligence technology. Accelerate the development of a high-quality life and health corpus to promote the research and application of large language models (LLMs) in medical device-related vertical fields. Facilitate the research, development, and application of intelligent decision-support knowledge models and algorithms, and promote the intelligent upgrading of key products. (Responsible units: the Municipal Commission of Science and Technology, the Municipal Commission of Economy and Informatization, the Municipal Data Bureau, the Municipal Commission of Health, and Shanghai Hospital Development Center)

2. Strengthening Clinical Research for Industry Advancement

(4) Improving the efficiency of clinical research. Medical institutions shall be encouraged to undertake clinical trials for high-end medical device products. Improve the efficiency of medical ethics review, with the goal of shortening the overall review process to within three weeks. Reduce the clinical trial start-up time, aiming to compress the overall internal time within medical institutions prior to trial initiation to less than 25 weeks. (Responsible units: the Municipal Commission of Health, and Shanghai Hospital Development Center)

(5) Promoting medical-engineering collaboration and research translation. Leveraging the National and Shanghai Clinical Medicine Research Centers, a cohort of clinical scientists shall be selected and cultivated to advance the clinical translation of innovative achievements. The role of institutions such as the Academy for Clinical Innovation and Translation of Shanghai shall be utilized to streamline the process from the incubation and translation of clinical achievements to industrialization, thereby introducing a batch of high-end medical device products. (Responsible units: the Municipal Commission of Science and Technology, the Municipal Commission of Education, the Municipal Commission of Health, the Municipal Talent Bureau, and Shanghai Hospital Development Center)

3. Optimizing Evaluation and Approval Services

(6) Strengthening capacity building. Support the Yangtze River Delta Center for Medical Device Evaluation and Inspection of the National Medical Products Administration (NMPA), in collaboration with the municipal medical products administrative department, universities, research institutes, clinical institutions, and relevant enterprises, to conduct regulatory scientific research on priority products. This initiative aims to formulate and revise product registration review guidelines and key evaluation points, and to support applications to establish NMPA's Innovative Research Bases. Proactive guidance services will be enhanced for the registration evaluation of Class II and Class III innovative medical devices. Compress the average evaluation time for Class II medical devices to within 40 working days. Establish municipal-level key laboratories in the fields of implantable medical devices and regulatory science. (Responsible units: the Municipal Medical Products Administration, and Yangtze River Delta Center for Medical Device Evaluation and Inspection of the NMPA)

(7) Deepening reform pilots. Support enterprises that have obtained registration certificates for imported or Chinese-mainland-produced medical devices to produce Class II and Class III medical devices in Shanghai. Optimize the regulatory framework for the filing of self-developed reagents in pilot medical institutions, and encourage them to continuously develop and file self-developed reagents based on urgent clinical needs. Make active efforts to gain approval for launching a pilot program on the transfer of medical device registration certificates. Explore the pilot use in Shanghai of medical devices that are marketed overseas but are not yet registered in China. (Responsible unit: the Municipal Medical Products Administration)

(8) Strengthening the standardization for innovative products. Encourage enterprises and institutions to participate in the development and revision of standards for innovative medical device products, such as neurostimulators, medical robots, and brain-computer interfaces. (Responsible unit: the Municipal Administration for Market Regulation)

4. Accelerating the Application and Promotion of Innovative Products

(9) Expanding application scenarios. Support the application and promotion of new diagnostic testing equipment in community screening. Explore and establish telemedicine application scenarios based on "6G+AI" technology, including remote high-precision operations and personal health management. (Responsible units: the Municipal Commission of Health, and Shanghai Hospital Development Center)

(10) Accelerating the promotion of innovative medical devices. Continuously update the "new and superior drugs and medical devices" catalog, promptly including medical device products approved through the national special review procedure for innovative medical devices. Public medical institutions shall organize evaluations and reviews for inclusion within 30 days after the catalog is updated, to facilitate the allocation and use of innovative medical devices. Vigorously cultivate household medical device brands and actively expand the out-of-hospital market. (Responsible units: the Municipal Commission of Science and Technology, the Municipal Commission of Health, the Municipal Medical Products Administration, and Shanghai Hospital Development Center)

(11) Optimizing the product payment mode. For "new and superior drugs and medical devices" that have been included in the catalog of single-use medical devices eligible for separate charges in medical institutions, expedite the processing of companies' online procurement applications. For medical devices selected for application demonstration projects but not yet included in the catalog of chargeable single-use medical devices, encourage medical institutions to submit proposals for pricing in accordance with national and local medical pricing provisions. Include relevant "new and superior drugs and medical devices" in the medical insurance payment scope; for diagnosis and treatment items involving innovative medical devices, implement separate medical insurance budget payments and separate payments under the DRG/DIP reform; in accordance with the provisions, assign relevant high-value innovative medical devices and innovative medical service items to independent groups under the DRG/DIP reform, raise their payment standards, and exempt them from limits on high-cost outlier cases. Encourage commercial insurance institutions to launch insurance products that cover liability for high-end medical devices. In accordance with the provisions, explore methods such as financial leasing and lease-to-own arrangements to encourage the adoption of innovative, large-scale medical equipment in medical institutions. (Responsible units: the Municipal Healthcare Security Administration, the Financial Office of the CPC Municipal Committee, the Municipal Financial Regulatory Bureau, and Shanghai Hospital Development Center)

5. Cultivating and Expanding High-caliber Enterprises

(12) Cultivating leading enterprises. Support enterprises in accelerating their international development and optimizing their business portfolios through mergers, acquisitions and other strategies. Support enterprises in collaborating with universities, research institutes, medical institutions, and third-party testing platforms to tackle technological challenges. Support small and medium-sized innovative enterprises in accelerating their growth into specialized and elite businesses, such as "Single Champions" and "Little Giants". (Responsible units: the Municipal Commission of Science and Technology, the Municipal Development and Reform Commission, and the Municipal Commission of Economy and Informatization)

(13) Supporting R&D and manufacturing by foreign-invested enterprises in Shanghai. Attract foreign-invested enterprises to establish regional headquarters, R&D centers, and production bases in Shanghai. Encourage them to synchronize their innovative product R&D and production cycles with global schedules or prioritize China as the first base for such activities. Support foreign-invested enterprises in partnering with medical institutions to conduct multi-center clinical trials, and accelerate product registration and market launch, thus promoting Shanghai as the preferred global hub for the registration and production of international innovative products. (Responsible units: the Municipal Commission of Commerce, the Municipal Commission of Science and Technology, the Municipal Commission of Health, and the Municipal Medical Products Administration)

(14) Innovating enterprise development models. Encourage enterprises to develop new business models such as "product + service" and "manufacturing + service" . Support them in formulating comprehensive solution packages that combine equipment, consumables, service, and training. Encourage the provision of value-added services such as maintenance for large medical equipment and comprehensive data solutions. (Responsible units: the Municipal Commission of Science and Technology, and the Municipal Commission of Economy and Informatization)

6. Building a First-class Industrial Innovation Ecosystem

(15) Optimizing the "Three-Zone Linkage" spatial layout. Facilitate municipal-district collaboration to develop three high-end medical device industry clusters in Pudong New Area, Minhang district, and Jiading district. This initiative will form an interconnected "Three-Zone Linkage" industrial spatial layout and cultivate distinctive, specialized industrial bases. (Responsible units: the Municipal Commission of Science and Technology, the Municipal Development and Reform Commission, the Municipal Commission of Economy and Informatization, the Municipal Bureau of Planning and Natural Resources, Pudong New Area People's Government, Minhang District People's Government, and Jiading District People's Government)

(16) Strengthening the public platform support system. Develop a number of high-quality incubators, proof-of-concept platforms, and other functional service platforms, with the goal of establishing national-level technology innovation platforms. Leverage Hongqiao International Central Business District to build an exhibition, training, and trading platform for medical devices, serving as a hub to aggregate and promote innovative medical device products. Expand the sales channels of medical devices by exploring new sales platforms targeting overseas markets to facilitate the direct sales of domestic products to overseas medical institutions. (Responsible units: the Municipal Commission of Science and Technology, the Municipal Development and Reform Commission, the Municipal Commission of Commerce, Shanghai Hospital Development Center, Hongqiao International Central Business District Administrative Committee, and Minhang District People's Government)

(17) Increasing financial support. Encourage leading industry parent funds and biopharmaceutical M&A funds to cooperate with industrial clusters. Effectively utilize the future industry fund to support relevant disruptive technologies and frontier innovations. Foster the development of market-oriented venture capital funds focused on medical devices and encourage the growth of market-oriented secondary (S) funds and acquisition (A) funds. Support the creation of high-end medical device insurance products for high-end medical services and establish a comprehensive mechanism that covers the entire innovation chain, including clinical trials, R&D, and production. (Responsible units: the Municipal State-owned Assets Supervision and Administration Commission, the Financial Office of the CPC Municipal Committee, and the Municipal Financial Regulatory Bureau)

(18) Accelerating the cultivation and aggregation of innovative talent. Encourage universities, research institutes and medical institutions to strengthen interdisciplinary programs and accelerate the training of high-quality, interdisciplinary talent for the medical device sector. Fully leverage various talent initiatives to attract and cultivate experts, improve talent evaluation mechanisms and incentive measures, and optimize the ecosystem for aggregating high-end medical device professionals. (Responsible units: the Municipal Talent Bureau, and the Municipal Commission of Education)

7. Promoting the International Development of the Industry

(19) Facilitating import and export customs clearance. Implement measures such as requiring imported medical devices to bear Chinese labels, and streamline customs clearance procedures for the R&D, production, market approval, and sales of medical device products. Seek to expand the range of equipment eligible for bonded maintenance and its business scope, supporting enterprises in providing bonded maintenance for high-tech, high-value-added products. (Responsible units: Shanghai Customs, the Municipal Medical Products Administration, the Municipal Commission of Science and Technology, and the Municipal Commission of Commerce)

(20) Deepening international exchange and cooperation. Leverage the comprehensive "Going-Global" service platform for enterprises to offer integrated support in finance, intellectual property, and legal affairs. Capitalize on the Oriental Hub International Business Cooperation Zone to establish an international medical device training and innovation platform, offering services for introducing overseas products to the domestic market and promoting domestic products abroad. Showcase innovative medical devices through various channels such as international conferences, and live broadcasts of cross-border surgical procedures. Actively participate in and bid to host internationally influential medical device exhibitions in Shanghai, enhancing the promotion of the city's business-friendly environment. (Responsible units: the Municipal Commission of Commerce, the Municipal Commission of Science and Technology, Oriental Hub International Business Cooperation Zone Administration, and Pudong New Area People's Government)

All tasks outlined in this Action Plan will be incorporated into the city's key list of priorities for the development of the biomedical industry. Comprehensive support and guarantees will be strengthened, with regular evaluations of policy measures and major projects conducted under a  dynamic management system to ensure efficient implementation.