Up to 5Million，Official Documents, Focusing on Supporting These Equipment Fields: High-end Imaging, IVD, Endoscopy

On July 26, the Shenzhen Development and Reform Commission issued a notice on three policy measures including the Several Measures for Shenzhen to Promote the High-Quality Development of Biomedical Industry Clusters.

Among them, the Several Measures for Shenzhen to Promote the High-quality Development of High-end Medical Device Industry Clusters (hereinafter referred to as Measures) shows that in order to increase the application demonstration of innovative products, medical device companies are supported to be included in volume procurement.

The Measures points out: “Enterprises are encouraged to actively participate in the national centralized procurement of medical devices to expand the market. The winning varieties are subsidized by 3% of the total procurement amount of the year. The maximum subsidy for a single variety is no more than 3million yuan, and the maximum subsidy for a single enterprise is no more than 5million yuan per year.”.

Below is the full text of the Measures:

I. Applicable institutions and key support areas

This Measure applies to registered enterprises with independent legal person status, engaged in the research and development, production, and service of medical devices, as well as other institutions, social groups, private non-enterprises，and other institutions.

This Measure focuses on supporting high-end medical imaging, in vitro diagnosis, life monitoring and life support, high-end implant intervention, emergency treatment, tumor radiotherapy, medical endoscopy, gene detection, optical equipment, DNA synthesizer, intelligent rehabilitation aids, health management and other instruments and equipment, various reagents and products required for disease screening and accurate drug use analysis, stent valves, ventricular assist devices, intraocular lenses, orthopedic devices and other high-end implant intervention products, biodegradable materials, tissue and organ induced regeneration and repair materials, new dental materials, high-value domestic alternative consumables and other biomedical materials, surgical robots, intelligent software and other AI information technologies in the application of medical equipment scenes.

II. Strengthening the innovation curation capacity of the medical device industry

i. Focusing on original innovation and convergence of medical devices. Relying on the existing national key platforms such as the National High-performance Medical device Innovation Center, actively undertake the tasks of national basic research, major scientific and technological transformation and industrialization, around the field of key components and new materials, strengthen cutting-edge high-level basic research and core technology to make up for the scientific and technological innovation and industrial integration of high-end medical devices in our city.

ii. Promoting the construction of key platforms for medical devices at the national, provincial，and municipal levels. Taking the initiative to undertake major national development strategic tasks such as the development of high-end medical devices and take the initiative to undertake major national core technology research and technology transformation tasks. Promoting the accelerated construction of the National High-Performance Medical Device Innovation Center; support the construction of National Key Laboratories, National Engineering Research Centers, and other national-level innovation carriers in Shenzhen, with a maximum support of thirty million yuan; support the construction of a National Enterprise Technology Center in Shenzhen, with the highest fifteen million yuan to support. Speeding up the construction of key platforms for municipal-level medical devices, and plan the layout of major industrial service platforms such as contract R & D organizations (CRO), contract customized R & D and manufacture organizations (CDMO), inspection and metrological testing platforms, medical device review and approval public service platforms and pilot test platforms, which shall be funded according to 40% of the total investment of the project, up to a maximum of 50 million yuan.

iii. Major scientific and technological industrial projects of municipal medical devices will be arranged. Supporting relevant units to integrate advantageous research forces and build a number of innovative research institutions with important influence. Continuing to lay out several batches of major municipal science and technology and industrial special projects and giving full funding of up to RMB 30 million to those conducting high-level basic research and technological research in frontier areas such as new materials, new mechanisms， and new principles. For the “neck” technology research and major industrialization projects focusing on the development of high-end imaging systems, surgical robots, new in vitro diagnostic equipment, high-end implant intervention products, high-performance medical chips, high-throughput gene sequencers and other major equipment, key parts and components, and key raw materials, and for the major equipment that took the lead in mass production in China, or the key parts and components or raw materials enterprises successfully applied to medical device products, the subsidy will be given by stages according to 40% of the total investment of the project, with a maximum of no more than 300million yuan.

iv．Building a full-chain industrial service system. Promoting the construction of key projects such as the Guangming Branch of Municipal Institute of Drug Inspection and Research (Municipal Medical Device Testing Center), and gradually build a full-chain public service system that integrates medical device registration and testing, biosafety assessment, product improvement, legal consultation, quality system establishment and follow-up verification.

III. Strengthening technological transformation and industrialization capabilities

v. Supporting the research and development and production of Class II and III medical devices. Financial support will be given to the medical device products in the key support fields that have completed the research and development and conducted industrial transformation in this city. For the first time approved class II medical device registration certificate and produced in this city, 40% of the actual R & D investment will be subsidized, and the maximum amount of a single variety will not exceed 3million yuan; for the first time approved Class III of medical device registration certificate and produced in this city, 40% of the actual R & D investment will be subsidized, and the maximum amount of a single variety will not exceed 5million yuan. For those who have passed the special approval procedures of national and provincial innovative medical devices and obtained the registration certificate of class II and III medical devices for the first time and are produced in this city, the upper limit of subsidy for a single variety will be increased by another 1million yuan. The maximum amount of subsidy received by a single enterprise each year is no more than 10million yuan.

 vi. Paying attention to the improvement of characteristic service ability in the research and development and application of medical devices. Strengthening the development and utilization of patent information resources and improve the ability and level of enterprises to develop high-end medical devices. Giving full play to the role of the National Medical Device Technical Review and Inspection Center in the Greater Bay Area, establish a counseling and communication mechanism for the key links of medical device registration and application, and provide local medical device companies with consulting services for the entire process of medical device registration and application. Medical device enterprises are encouraged to actively entrust an accredited municipal CDMO service platform or a CRO service platform headquartered in Shenzhen (which has no investment relationship with the enterprise) to provide services.

vii. Encouraging the construction of medical device production sites. For enterprises that build or renovate GMP workshops in the direction of medical devices and have obtained a medical device production license, a subsidy of up to 10 million yuan will be given according to 40% of the actual new construction or renovation costs, up to 3,000 yuan/㎡, to meet the industrialization need of enterprises.

viii. Encouraging local industrialization of medical device products. For those who obtain the medical device product registration certificate and realize industrialization in this city, or the medical device manufacturing enterprises in this city undertake production according to the medical device registrant filer system (the entrusting parties have no investment relationship), 20% of the actual investment cost will be subsidized, with a maximum of 15million yuan for a single product and 30million yuan for a single enterprise every year.

ix.  Promoting the participation of third-party organizations in clinical trial management. Exploring third-party organizations to carry out capacity certification, annual self-inspection, evaluation inspection, etc. of clinical trial institutions, and carry out supervision of the clinical trial process of registration applicants.

x. Optimizing the medical device industry environment. Up to 500,000 yuan will be given to institutions in the medical device field approved by the national, provincial and municipal authorities, official journals with unified domestic issue numbers and think tanks, etc. Supporting the holding of municipal high-level medical device summits or exhibitions and give full subsidies to the summits or exhibitions approved by the municipal government according to the expenses confirmed after audit, with a maximum of no more than five million yuan. Establishing a high-end medical device industry alliance that unites the upstream and downstream of the industrial chain to promote the high-quality development of high-end medical device industry clusters and grant up to five million yuan in subsidies based on the best projects.

IV. Increasing the application demonstration of innovative products

xi. Optimizing the process of entering the hospital for innovative medical device products. For the registered products of medical devices that are included in the special review procedures of national or provincial innovative medical devices and can be charged separately, they can apply for online listing on the Sunshine Platform with the medical device registration certificate or filing certificate. At the same time, the Municipal Medical Security Bureau will actively guide the enterprises in need to apply for code assignment to the National Medical Insurance Bureau and purchase online on the Sunshine Platform. For innovative medical consumables other than medical service items that cannot be charged separately, establish a green channel for new medical service price items to accelerate the clinical use of innovative products. Organizing medical institutions to establish a medical device clinical use management committee, which is responsible for guiding and supervising the clinical use of medical devices.

xii. Strengthening the application demonstration of the first set of medical devices. Increasing the first purchase of innovative medical devices, increase the share of government procurement, encourage medical institutions in this city to purchase the first (set) of medical devices certified by relevant municipal departments, establish a contact mechanism between users (medical institutions) and local enterprises, and promote medical institutions understand and use products produced by local businesses.

Xiii. Exploring the establishment of pilot use of medical devices already on the market in Hong Kong and Macao. In conjunction with the Dawan Area Sub-Center for Technical Evaluation and Inspection of Medical Devices of the NMPA, actively apply for the state to delegate the authority of examination and approval of Hong Kong and Macao listed medical devices to designated medical institutions in Shenzhen, encourage Hong Kong and Macao listed medical devices to conduct real-world research on the joint evaluation, medical, testing and industrial public service platform in Shenzhen. Explore the review and approval process for medical devices listed in Hong Kong and Macao but not listed in the mainland in Shenzhen and promote the pilot use of Hong Kong and Macao listed medical devices in Shenzhen.

xiv. Supporting medical device enterprises to develop overseas markets. For high-end medical devices that have completed R & D and industrialization locally and have been approved by the U.S. Food and Drug Administration (FDA), the Japanese Pharmaceutical and Medical Device Comprehensive Administration (PMDA), the European Community (CE) and other institutions, and have obtained overseas listing qualifications and achieved sales in relevant foreign markets, subsidies will be given according to the actual costs incurred after the audit, and the maximum annual cost of a single enterprise will not exceed 10million yuan.

xv. Supporting medical device companies to include in-volume procurement. Enterprises are encouraged to actively participate in the national centralized procurement of medical devices to expand the market. The winning varieties are subsidized by 3% of the total procurement amount of the year. The maximum subsidy for a single variety is no more than 3million yuan, and the maximum subsidy for a single enterprise is no more than 5million yuan per year.

V. Deepening the reform of clinical trials

xvi. Increasing incentives for clinical trials of medical devices. Accredited clinical trial beds are not included in the management of the number of beds in medical institutions, and no assessment of bed efficiency, turnover rate, and utilization rate is conducted. Great efforts should be made to introduce and cultivate clinical research talents, optimize the clinical research talent evaluation system, medical device clinical trial projects are regarded as scientific research projects of corresponding levels according to different sources and levels, and include the performance salary, professional title promotion, and position of the principal investigators and direct participating researchers.

xvii. To establish a mechanism for the review of ethical cooperation in medical institutions. Establishing the cooperative review mechanism of the ethics committee of medical institutions in this city and carry out the cooperative ethical review of clinical research in multi-medical institutions. The ethics committees of medical institutions that have signed the collaborative review agreement can explore the mutual recognition of the results of ethical review of clinical research in medical institutions under the principle of following the relevant national laws and regulations and guidelines, so as to effectively reduce the repeated approval of clinical trials and shorten the cycle of innovative product development. Exploring the establishment of a clinical research alliance for medical devices.

xviii. Promoting medical device enterprises to strengthen the ability of clinical self-examination. Qualified enterprises are encouraged to invest in the establishment of clinical trial testing institutions, and the product self-test report of the enterprise can be used as the examination report when applying for registration and certification. Clinical trial and testing institutions shall, in accordance with the requirements of clinical trial quality management standards, regularly conduct self-examination and accept supervision and inspection by the competent department.

xix. Encouraging the development of clinical trial services for medical devices. Supporting medical institutions to conduct clinical research on medical devices and incorporate clinical research on medical devices into the performance evaluation index system of top three public hospitals. For medical institutions that have obtained the qualification of clinical trials of medical devices according to GCP and provide more than 10, 20, or 40 clinical trial service projects for medical device enterprises every year, the leading unit shall be subsidized with a maximum of RMB 1, 2, or 3 million yuan，and the maximum subsidy given to participating units is not more than 500,000 yuan, 1 million yuan and 1.5 million yuan.

xx．Improving the efficiency of customs clearance of key medical equipment items. Setting up a municipal information exchange and supervision service platform covering the whole process of customs clearance, establish a multi department joint evaluation and supervision mechanism for the import of goods for research and development, simplify the pre-approval procedures for relevant goods, facilitate the customs clearance of enterprises, gradually pilot and promote the joint supervision mechanism for entry-exit special goods in the city, and strengthen safety supervision.

VI. Making every effort to create a medical device characteristic park

xxi. Optimizing the space supply policy of the medical device industry. The municipal competent industrial department is responsible for the overall planning, and the key areas of high-end medical device industry clusters are specifically responsible for establishing industrial land, industrial housing and other industrial development strategic space reserves to ensure that the late development needs of high-quality enterprises are met in a timely manner. For the identified characteristic parks, innovate the way of supplying industrial space, make good use of the high-quality industrial supply policy, explore and adopt the mode of joint construction of cities and districts, and vigorously promote the high-end development of medical device characteristic industrial parks. Adopting the method of renting before selling, explore the sales model of property rights division, and explore “customized” services for different space needs of enterprises at different stages. The proportion of other industrial purposes and living facilities that can be built in single-use industrial land is increased to 30% of the total construction area, of which the proportion of living facilities such as retail, catering, and dormitory does not exceed 15% of the total construction area.

xxii. Paying attention to the transformation and construction support of medical device characteristic parks. For the identified new or existing industrial space reconstruction characteristic parks, green channels shall be opened in the process of project approval, registration and approval, gas supply, steam supply, heat supply, power supply and water supply shall be stable and up to standard, the application of 5g and optical fiber and other infrastructure should be promoted, various industrial service platforms shall be encouraged in the park, and the park should be equipped with waste water, waste gas, solid waste and other collection and disposal monitoring facilities, as well as necessary supporting facilities such as ethylene oxide sterilization room. For the area where the industrial parks are concentrated, the public supporting facilities such as hazardous chemical transfer stations shall be constructed as a whole to promote resource sharing and full utilization. The Construction Party of the park will be subsidized according to 10% of the total construction investment, with a maximum of no more than 100million yuan; enterprises that meet the standards and settle in the park will be subsidized at the proportion of 50% of the government rent benchmark price for three consecutive years, and the maximum amount of subsidy per enterprise per year will not exceed 5million yuan; for the cost of water / electricity / gas in the previous year, 50% of the subsidy will be given to the settled enterprises according to the scheme of “paying first and then making up”, with a maximum of no more than 2million yuan per year, for a total of 3 years from the signing of the contract; the operating enterprises in the park will be subsidized according to the proportion of 20% of the operating cost, with a maximum of no more than 5million yuan per year, for a total of 3 years from the date of official production.

xxiii. Strengthening the support for talents in medical device characteristic parks. For the identified parks, all districts are encouraged to provide high-end talent apartments, and key talents who meet the city’s talent introduction standards are settled in batches and solve the problem of children’s schooling in territorial school districts in economic coordination within the scope of the policy. Support to increase the training of talents in the park, including industrial workers, and support the park to build a skill training base with vocational colleges and training institutions. For the approved training projects, 50% of the training costs within three years will be given, with a maximum of no more than 5million yuan.

VII. Organizational guarantee

xxiv. Improving the talent guarantee mechanism. Establishing and improve a multi-level talent training system for the medical device industry and strengthen the construction of related disciplines in the medical device industry. Encouraging schools and enterprises to jointly carry out professional training and improve the professional title evaluation and promotion channels of medical device talents. Support enterprises to introduce high-level management, R&D, and service talents in the medical device field, and provide security services in housing security, children’s schooling, and medical care.

xxv. Strengthening the land security mechanism. Priority shall be given to ensuring the land use indicators of major industrial projects. For key projects that are implemented in key areas of municipal medical device industry clusters, priority shall be given to being included in the list of national and provincial major projects and advanced manufacturing projects in Guangdong Province. If it is really impossible to be included, the municipal-level new construction land indicators will be used as a whole to solve the problem. Supporting the rational use of stock land and industrial buildings for the development of characteristic medical device parks and expand the development space of the medical device industry. Under the overall planning of the municipal competent industrial department, the key areas of the medical device industry cluster are responsible for quantifying the annual indicators of industrial land and industrial housing.

xxvi. Improving the assessment and evaluation mechanism. Establishing a differentiated evaluation system, pay attention to the characteristics of different departments and tasks, organically combine the outcome indicators with the process situation, fully reflect the incentive and restraint of the evaluation content, strengthen the evaluation operation, adhere to the combination of daily evaluation and year-end evaluation, qualitative evaluation，and quantitative scoring, and enhance the integrity and systematisms of the evaluation method.

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