Guangdong province promotes medical devices

High industrial qualityDevelopment implementation plan

***,Earnestly implement the Party Central Committee Deployment requirements of the State Council,Accelerate the high-quality development of medical device industry in our province,Enhance core competitiveness,Better meet the growing health needs of the people,The scheme is specially formulated.

one General requirements

one guiding ideology.

***,Thoroughly implement the spirit of the 19th CPC National Congress and all previous plenary sessions of the 19th CPC National Congress,***,Earnestly practice the people-centered development thought,Based on the new development stage Implement the new development concept Building a new development pattern Promote high-quality development,Further implement the innovation driven development strategy,Give full play to the advantages of medical device industry in our province,Highlight the focus Make up the short board Improve innovation ecology,Strive to realize industrial chain integration Value chain promotion,Realize the innovation and development of medical devices.

two Development goals.

Closely follow the theme of promoting high-quality development,Strengthen planning guidance and policy support,Strengthen originality Leading scientific and technological breakthrough,Build an innovation ecology of medical devices with innovation leading industrial development,Strive to break through key core technologies,Enhance the independent and controllable ability of key parts and key raw materials,Promote the supervision ability of medical devices in our province to take the lead in reaching the international advanced level.

Strive to2023year,The average annual compound growth rate of operating income of medical device manufacturing industry reached20%above,The annual operating income of medical device manufacturing industry above Designated Size reached1700RMB100mn The approved national innovative medical device registration certificate has reached30individual Listed enterprises in the capital market have reached30home Formed in Guangzhou Shenzhen is a dual core high-end medical device industry cluster.

Strive to2025year,The average annual compound growth rate of operating income of medical device manufacturing industry reached20%above,The annual operating income of medical device manufacturing industry above Designated Size reached2500RMB100mn The approved national innovative medical device registration certificate has reached50individual Cultivate listed enterprises in the capital market to achieve35home,Demonstration enterprises with a market value of more than 100 billion yuan2 3home,Annual operating income exceeds100Billion yuan leading enterprise3 5home,exceed50Billion yuan of leading enterprises5 8home Build a number of backbone enterprises with independent brands with international influence,Form a world-class high-end medical device industry cluster.

two Key tasks

one Improve the overall efficiency of medical device innovation chain.

1.Improve the construction of innovation system.Building an enterprise oriented Market oriented Medical device technology innovation system with deep integration of industry, University and research.Vigorously improve the source innovation ability of high-end medical devices,Focus on cutting-edge technology,In high-end medical imaging and advanced treatment equipment High end in vitro diagnostic instruments and reagents Gao Duanzhi Introduce Enter the fields of devices and biomedical materials, and speed up the research on key core technologies and applications.Optimize and innovate the linkage working mechanism of research and examination of medical devices,Optimize communication methods and channels,Strengthen technical guidance and consulting services for applicants. Led by provincial science and Technology Department,The provincial food and drug administration shall be responsible according to the division of responsibilities

2.Promote the transformation of scientific and technological achievements.Support the establishment of medical achievement transformation platform,In discipline personnel project Transformation and other aspects with the help of the platform,Promote the industrialization of medical achievements.Support medical device R & D and transformation institutions to undertake colleges and universities Scientific research institutes Medical institutions have significant application prospects and innovative research results.Accelerating new technologies of medical devices Landing application of new products.Establish a reasonable distribution mechanism of responsibilities and rights of all participants in the transformation of achievements.Strengthen the intellectual property protection of medical devices,Establish rapid patent examination Rapid confirmation of rights Collaborative protection system for rapid rights protection Timely provide trademark registration Intellectual property analysis and evaluation Intellectual property fast financing loan service,Promoting intellectual property transactions. Led by provincial science and Technology Department,provincial department of public education Health Commission The market supervision bureau and the Municipal People's governments above the prefecture level shall be responsible according to the division of responsibilities

3.Strengthen the combination of medicine and industry and collaborative innovation.Support medical and health institutions Clinicians participate in medical device technology innovation,Actively carry out collaborative research and development of medical devices Bring the construction of clinical trial institutions into the important content of the construction and development of medical and health institutions,Establish a working mechanism for ethical collaborative review of clinical trials,Explore the incentive mechanism of clinical trial institutions and medical personnel,Promote the innovation of medical device industry. Led by Provincial Health Commission,The provincial food and Drug Administration and the Municipal People's governments above the prefecture level shall be responsible according to the division of responsibilities

4.Guide the innovation and development of high-end medical device industry.In biomedical materials plant Introduce Entry instrument Gene detection Surgical robot Artificial intelligence medical device Cultivate a number of major industrial projects in key fields such as medical endoscope.Support the leading enterprises in the subdivided fields of our province to build a national manufacturing innovation center.Give full play to the advantages of Dawan division center for technical evaluation and inspection of medical devices of the State Drug Administration,Promote the leading and radiating role of medical device innovation in Dawan District. Led by provincial development and Reform Commission,Provincial Department of industry and information technology The food and Drug Administration and the Municipal People's governments above the prefecture level shall be responsible according to the division of responsibilities

two Promote the optimization and upgrading of medical device industry chain.

5.Focus on solving the problems in the industrial chain Stuck neck problem.Layout and strengthen key materials Core components components and parts Capacity building of advanced technology.Support medical device enterprises and upstream enterprises to tackle cross industry collaborative technology problems,Upstream enterprises enjoy the same policy treatment.Supplement and strengthen the short board in the fields related to medical devices.Medical device registration matters involved,Included in the scope of priority review and approval services. Provincial Department of science and technology Led by the Department of industry and information technology,Provincial Development and Reform Commission The food and Drug Administration and the Municipal People's governments above the prefecture level shall be responsible according to the division of responsibilities

6.Support enterprise technological transformation.Increase support for technological transformation of medical device enterprises,Encourage enterprises to adopt applicable new technologies New process New equipment Technical transformation of new materials,Promote enterprises to expand investment in equipment renewal and technological transformation,Qualified technological transformation projects for manufacturing enterprises,According to its equipment purchase amount A certain proportion of investment in technological transformation will be given support.Strengthen the research and support for the intelligent manufacturing level of the medical device industry. Led by Provincial Department of industry and information technology,The Provincial Department of Finance and the Municipal People's governments at and above the prefecture level shall be responsible according to the division of responsibilities

7.Support industrial R & D.Support the leading enterprises in the subdivided fields of the medical device industry in our province to build a product R & D center.Accelerate the R & D and industrialization of relevant fields,Improve production process and product quality,Improve the development level of medical device industrialization.Strengthen the research and development of advanced traditional Chinese medicine medical devices,Promote the modernization of traditional Chinese medicine medical devices. Provincial Department of science and technology Led by the Department of industry and information technology,Provincial Health Commission The food and Drug Administration and the Municipal People's governments above the prefecture level shall be responsible according to the division of responsibilities

8.Build a national application demonstration base.Promote the construction of demonstration and Application Center for health care big data and domestic innovative medical device products.Ministry of industry and information technology Advanced medical equipment application demonstration project of the National Health Commission 5G+Based on the pilot project of medical and health application,Support relevant enterprises and medical institutions to establish demonstration bases with regional radiation influence,Form R & D-application-feedback-improvement-Benign mechanism of promotion,Help enterprise product iterative upgrade. Provincial Development and Reform Commission Led by the health and Health Commission,Provincial Department of industry and information technology The food and drug administration shall be responsible according to the division of responsibilities

three Implement echelon cultivation of medical device enterprises.

9.Strengthen leading enterprises.Leading enterprises are encouraged to target the key links and core technologies of the industrial chain,Carry out joint venture and cooperation Merger and reorganization,Integrate resources Complementary advantages,Strengthen brand cultivation,Continuously improve core competitiveness and industry driving force.Optimize service,The medical device products undertaking industrial transfer will be included in the scope of priority review and approval services,Simplify the application data requirements for transferred products. Led by Provincial Department of industry and information technology,Provincial Market Supervision Bureau The food and drug administration shall be responsible according to the division of responsibilities

10.Promoting the growth of small and medium-sized enterprises.Guided by the clinical value of small and medium-sized enterprises,Focus on key core technologies,Improve innovation capability and market share,go Specialized and new Development path.Cultivate a number of subdivided fields of medical devices Little giant Enterprises and manufacturing single champion enterprises,Included in the scope of priority review and approval services. Provincial Department of industry and information technology Led by China food and Drug Administration,The provincial market supervision bureau shall be responsible according to the division of responsibilities

11.Promote the construction of advanced manufacturing clusters.Enhance the leading role of leading and backbone enterprises,Strengthen professional cooperation and supporting capacity,Further promote the development of industrial clusters.Supporting cluster promotion institutions,Vigorously promote Shenzhen Guangzhou high-end medical devices National advanced manufacturing cluster construction,Promote the agglomeration of advantageous resource elements Cross industry collaboration.Support the construction of common technology R & D platform and public service platform.Strengthen the coordination and guidance of advanced manufacturing cluster projects. Provincial Department of science and technology Led by the Department of industry and information technology,The provincial food and Drug Administration and the Municipal People's governments above the prefecture level shall be responsible according to the division of responsibilities

four We will vigorously support enterprises to become better and stronger.

12.Promote the application of product specifications.Accelerate the clinical promotion and use of innovative medical devices.Improve medical service prices and medical insurance payment policies,Dynamically adjust the catalogue of medical consumables and medical service prices of medical insurance,Timely include new medical consumables and products into the payment scope of medical insurance according to regulations,Improve the coordination mechanism between medical insurance payment standard and centralized purchase price,We will actively promote the direct settlement between medical insurance funds and medical consumables enterprises.Strengthen the construction of intelligent supervision information system for medical devices,Improve the data information sharing mechanism,Improve the efficiency of bidding procurement. Led by Provincial Medical Insurance Bureau,Provincial Department of Finance Health Commission The food and drug administration shall be responsible according to the division of responsibilities

13.Support clinical use of products.Medical institutions are encouraged to increase their understanding of efficacy Controllable quality Purchase and use of domestic medical devices with stable supply.Support the first set of high-end medical equipment set Production in our province,Those settled and produced in our province are listed as the first one set Large medical equipment in the guidance catalogue for the promotion and application of major technical equipment,According to the first set of domestic equipment set Implementation of relevant document requirements. Led by Provincial Health Commission,Provincial Department of Finance Medical Insurance Bureau The food and drug administration shall be responsible according to the division of responsibilities

14.Broaden direct financing channels.We will continue to promote the listing and financing of high-quality enterprises in domestic and foreign securities markets,Support qualified enterprises to finance through equity Corporate credit bonds Asset Securitization,Expand direct financing channels.Guide all kinds of equity investment institutions Private equity investment funds and venture capital funds invest in the medical device industry.Enhance the role of government guidance fund in the seed stage of enterprises Angel investment,Encourage teams with medical industry background or industrial companies to establish venture capital funds Angel Fund and other early medical industry sub funds.Listed company Companies listed on the new third board and companies to be listed that have completed counseling and filing shall be included in the scope of priority review and approval services.(Led by Provincial Local Financial Supervision Bureau,Provincial Development and Reform Commission Department of industry and information technology Drug Administration,Guangdong Securities Regulatory Bureau Shenzhen Securities Regulatory Bureau shall be responsible according to the division of responsibilities)

five Promote international exchanges and cooperation.

15.Promote the steady development of exports.Implement and improve export tax rebate Export credit policy,Support the export of medical device products.Encourage the promotion of new marketing formats such as online exhibition and sales,Improve the supervision mechanism suitable for the healthy development of new business marketing.Enterprises are encouraged to participate in overseas medical device exhibitions and academic conferences,Support the holding of international medical device exhibitions and academic conferences. Provincial commerce,s%s s%s,s%s s%s

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