Several Policy Measures of Sichuan Province to Support the High-Quality Development of the Medical and Healthcare Equipment Industry
2022-03-07 00:00

Original Title: Several Policy Measures to Support the High-Quality Development of the Medical and Health Equipment Industry

To thoroughly implement the series of major strategies of the CPC Central Committee and the State Council regarding building a manufacturing powerhouse and a Healthy China, and to carry out the arrangements and deployments of the Provincial Party Committee and Provincial Government on deepening innovation-driven development and accelerating the high-quality development of the manufacturing sector, we are committed to fostering new growth drivers, building new competitive advantages, and accelerating the high-quality development of the medical and health equipment industry. In light of the actual conditions of our province, the following policy measures are hereby formulated.

I. Strengthening Research and Development of Core Technologies. Focusing on the priorities and key areas of the medical and health industry’s development, we will “define priorities based on demand” to organize and implement major scientific and technological projects for medical and health equipment. We will dynamically publish a catalog of core technology R&D initiatives in fields such as high-end medical equipment, core components, and key materials. Projects involving nuclear medicine and medical radionuclide equipment, high-end medical imaging and therapeutic equipment, new in vitro diagnostic equipment, key dental diagnostic and treatment equipment, monitoring and life support equipment,traditional Chinese medicine (TCM) diagnostic and pharmaceutical equipment, as well as key components and materials, into the scope of support for major science and technology projects and major industrial key technology (product) R&D projects. Strengthen intellectual property protection for core technologies, conduct intellectual property early warning research for medical and health equipment, and enhance the intellectual property risk-resilience of enterprises and research institutions.(Responsible Departments: Department of Science and Technology, Department of Economy and Information Technology, Department of Finance, Provincial Market Regulation Bureau, Provincial Intellectual Property Center, Provincial Health Commission, Provincial Bureau of Traditional Chinese Medicine, Provincial Drug Administration. The department listed before the comma is the lead department; the same applies below)

II. Accelerate the Construction of Innovation Platforms. Support enterprises in taking the lead to establish high-level collaborative innovation platforms that integrate industry, academia, research, healthcare, elderly care, and end-users. Strengthen local matching support for innovation platforms successfully designated as national-level manufacturing innovation centers, industrial innovation centers, or engineering research centers. Provide a subsidy of 10 million yuan to innovation platforms successfully designated as branch centers of national-level manufacturing innovation centers or provincial-level manufacturing innovation centers.[Responsible Departments: Provincial Development and Reform Commission, Department of Economy and Information Technology, Department of Finance, Department of Science and Technology, Provincial Health Commission, Provincial Drug Administration, and People’s Governments of all cities (prefectures)]

III. Enhancing Clinical Research Capabilities. Support the development of clinical research-oriented hospitals and model research wards. For key medical institutions conducting clinical research and the commercialization of research outcomes, clinical research beds shall not be included in the institution’s total bed count management, nor shall they be subject to evaluations of bed efficiency, turnover rates, or utilization rates. When allocating senior-level positions in hospitals, the number of positions designated for clinical researchers shall be appropriately increased; for healthcare institutions with heavy research workloads, the proportion of senior-level positions for professional and technical personnel may be appropriately raised.Clinical trial projects shall be treated as scientific research projects and serve as an important basis for the professional title evaluation, promotion, and performance appraisal of medical personnel. For medical personnel who make major contributions to clinical research on medical and health equipment and the commercialization of innovative achievements, cash rewards received from the commercialization of scientific and technological achievements in their official capacity shall not be subject to the annual performance wage cap of their institution and shall not be included in the total wage base. Strengthen ethical review in key medical institutions and promote mutual recognition of ethical review results for multicenter clinical research.(Responsible Departments: Provincial Health Commission, Provincial Bureau of Traditional Chinese Medicine, Department of Science and Technology, Department of Human Resources and Social Security, Provincial Drug Administration)

IV. Support Increased R&D Investment. Medical and health equipment enterprises with annual R&D expenditures of 10 million yuan or more, accounting for no less than 3% of their operating revenue, shall be granted subsidies based on a certain percentage of the annual increase in R&D investment. Implement risk-sharing mechanisms for R&D investment to reduce enterprise research risks; for key R&D projects in medical and health equipment with investments of 500,000 yuan or more, provide risk-sharing funds of up to 30% of the actual investment loss, with a maximum of 1 million yuan.(Responsible Departments: Department of Economy and Information Technology, Department of Science and Technology, Department of Finance, Provincial Drug Administration)

V. Strengthening the Development of Intelligent Equipment. Support the use of new technologies such as big data, cloud computing, artificial intelligence, and 3D printing to develop medical and health software, data centers, application-specific integrated circuits (ASICs), and biochips, as well as new types of pharmaceutical and analytical testing equipment, intelligent diagnostic and testing equipment, intelligent mobile medical equipment, intelligent health and rehabilitation equipment, and intelligent wearable devices.For the first-of-its-kind medical and health equipment products, innovation breakthrough grants, insurance premium subsidies, or sales incentives will be provided in accordance with regulations. For the first version of medical and health equipment software successfully deployed, a grant of up to 20% of the software development costs, with a maximum of 5 million yuan, will be provided. (Responsible Departments: Department of Economy and Information Technology; Department of Finance; Department of Science and Technology; Department of Civil Affairs; Provincial Drug Administration)

VI. Strengthening the Commercialization of Innovation Outcomes. For industrialization projects involving major scientific and technological special projects for medical and health equipment, as well as high-end medical and health equipment and key integrated equipment designed for import substitution or domestic first-of-their-kind innovation, a subsidy of up to 10% of the investment amount, not exceeding 50 million yuan, will be provided. Projects that obtain a Class III Medical Device Registration Certificate (National Innovative Medical Device) and achieve industrialization will be awarded a 5 million yuan incentive.Projects that have obtained Class II or Class III medical device registration certificates (excluding diagnostic reagents, low-value consumables, and National Innovative Medical Devices) and have been industrialized, or projects involving domestic Class III medical devices registered and marketed in European and American countries, shall be granted a reward of up to 2 million yuan. (Responsible Departments: Department of Economy and Information Technology, Department of Finance, Department of Science and Technology, Provincial Drug Administration)

VII. Support for New Business Models and Formats.The Medical Device Registrant System will be thoroughly implemented. Enterprises engaged in contract manufacturing for the initial registration of medical devices will receive a subsidy of up to 2 million yuan, calculated at 2% of the actual annual contract value. For enterprises that lead the development of integrated innovation service platforms for medical and health equipment—such as telemedicine, intelligent diagnosis, and data centers—in collaboration with medical and health institutions, with an investment of 10 million yuan or more, a subsidy of up to 3 million yuan will be provided, calculated at 5% of the fixed-asset investment.Enterprises providing financial leasing services for key integrated medical and health equipment, with an annual contract value of 20 million yuan or more, will receive a subsidy of 2% of the actual contract value, up to a maximum of 1 million yuan. (Responsible Departments: Department of Economy and Information Technology, Department of Finance, Provincial Health Commission, Provincial Drug Administration)

VIII. Supporting Enterprises in Reaching New Heights. Benchmark and leading enterprises in the domestic and international medical and health equipment sectors that establish regional headquarters, R&D centers, or production bases in Sichuan shall be prioritized for investment attraction, with strengthened local supporting measures. “Gongga Excellence” enterprises, “Single-Champion” enterprises, and “Specialized, Refined, Unique, and Innovative” (SRUI) “Little Giant” enterprises in the medical and health equipment sector shall be granted awards and subsidies in accordance with relevant regulations.Support enterprises in integrating upstream and downstream industrial chain resources and carrying out mergers and acquisitions. Eligible enterprises will receive subsidies of up to 4 million yuan. [Responsible Departments: Department of Economy and Information Technology, Provincial Bureau of Economic Cooperation, Department of Finance, and People’s Governments of all cities (prefectures)]

IX. Cultivating Distinctive Industrial Clusters. Support eligible cities (prefectures) in planning and constructing specialized industrial parks (incubators, bases, or specialty towns) for medical and health equipment, and in building a specialized supporting system that integrates technology transfer, testing and inspection, and public services. Provide support in terms of spatial planning, park development, factor allocation, and supporting infrastructure.Support the construction of demonstration bases for entrepreneurship and innovation among small and micro enterprises, as well as specialty towns and industrial parks, and provide awards and subsidies in accordance with relevant regulations. [Responsible Departments: Department of Economy and Information Technology, Provincial Development and Reform Commission, Department of Finance, Department of Natural Resources, Department of Ecology and Environment, Department of Housing and Urban-Rural Development, and People’s Governments of all cities (prefectures)]

X. Optimize Review and Approval Services. Implement the Five-Year Action Plan for Improving the Quality of Medical Device Review and Approval Services; establish and improve a tracking system for key projects and a resident representative system for key parks; formulate and publish the Sichuan Medical Device R&D Process Reference Guide; expand Sichuan’s medical device testing qualifications and capabilities; and further expand related services for medical device R&D testing.Implement and refine the mechanism for coordinating medical device R&D and review. Expedite the approval process for medical device varieties included in the national (provincial) special review procedure for innovative medical devices, the key project tracking system, or those developed in accordance with the Sichuan Medical Device R&D Process Reference Guide. Reduce the review and approval timeline for Class II medical devices by 50% and increase the first-time approval rate. (Responsible Department: Provincial Drug Administration)

XI. Strengthen Product Promotion and Adoption. Support medical and health equipment enterprises in participating in centralized volume-based procurement of medical devices. Dynamically publish the list of “Renowned, Excellent, Unique, and Innovative” medical and health equipment products. For new medical devices that meet the requirements of the provincial emergency reserve catalog and are domestically controlled, prioritize their inclusion in reserve management in accordance with relevant regulations.For products approved for market release under the national (provincial) special review procedure for innovative medical devices, promptly list them for procurement on the provincial medical device procurement platform; where eligible, include them in the scope of basic medical insurance coverage in accordance with relevant regulations. Include the purchase of protective supplies and devices managed as medical devices at designated medical insurance institutions within the scope of payments from the individual accounts of the Urban Employee Basic Medical Insurance. (Responsible Departments: Provincial Medical Insurance Bureau, Department of Economy and Information Technology, Provincial Health Commission, Department of Finance, Provincial Drug Administration)

XII. Strengthen Quality and Brand Development. Conduct quality supervision of medical and health equipment and build a credit system, establishing a system of “white lists” and “black lists” for quality and credit. Support medical and health equipment enterprises and industry associations in taking the lead or participating in the formulation of a set of high-level standards with independent intellectual property rights. For enterprises or industry associations that lead the formulation and obtain approval for the release of national or international standards in the medical and health equipment sector, a reward of 200,000 yuan and 300,000 yuan, respectively, will be granted for each standard.Support applications for registration and certification with international bodies such as the U.S. Food and Drug Administration (FDA) and the European Union (CE) to facilitate the entry of products and services into international markets. Medical and health equipment enterprises or products that win the “China Industrial Grand Prize” or the “China Quality Award” will be granted a reward of up to 5 million yuan, depending on the award category.Organizations or individuals in the medical and health equipment sector that win the “Tianfu Quality Award” or its nomination award will receive financial subsidies in accordance with relevant regulations. Enterprises whose products win nationally or internationally renowned industrial design awards and are subsequently commercialized will be awarded 500,000 yuan and 1,000,000 yuan, respectively. (Responsible Departments: Department of Economy and Information Technology, Provincial Market Regulation Bureau, Department of Finance, Provincial Drug Administration)

XIII. Strengthen Financial Support. Support financial institutions in enhancing financing services for medical and health equipment enterprises. Launch the “Zhi Hui Dai” financing pilot program for manufacturing enterprises, encouraging financial institutions to provide medium- and long-term financing services to eligible medical and health equipment manufacturers. Encourage innovation in financing services and promote new financing models such as supply chain financing and intellectual property securitization. Implement a tiered cultivation program for enterprise listings, supporting eligible enterprises in listing and raising capital on domestic and international capital markets. Support the establishment of medical and health equipment industry investment funds through market-oriented mechanisms.(Responsible Departments: Provincial Local Financial Regulatory Bureau, People’s Bank of China Chengdu Branch, Department of Economy and Information Technology, Department of Finance, Provincial State-owned Assets Supervision and Administration Commission, Sichuan Banking and Insurance Regulatory Bureau, Sichuan Securities Regulatory Bureau)

These measures shall take effect from the date of issuance and remain valid for five years. The mechanism for provincial leaders to provide guidance to the medical and health industry shall be utilized to coordinate and advance the development of the medical and health equipment industry. Different projects within the same enterprise may apply for corresponding support programs. In cases where there is overlap with other similar policies in our province, support shall be provided in accordance with the principle of “selecting the most favorable, applying the highest standard, and avoiding duplication.”

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