The Central Government has paid unprecedented attention | 32 kinds of domestic medical equipment will accelerate into the hospital
On April 19th, April 19th, 2018, the National NDRC and other eight ministries and commissions jointly issued the “Opinions on Promoting the First Major Technical Equipment Demonstration Application” (Development and Reform Industry [2018] No. 558), which will greatly benefit Domestically innovative medical equipment went into the government bidding and procurement, and the important documents that entered the public hospital finally came out.
Supporting the first set of equipment, the national policy has been repeatedly upgraded
In order to promote innovation and development made in China, the party and the country have successively introduced many policies and have done many things. medical instruments In the field, there are typically various science and technology and research and development specialties, special approvals for medical devices, and priority approvals.
However, domestic research and development of innovative equipment, after listing, although it has advantages over imports, may not be well promoted.
Because it has not been put into use before, equipment application parties dare not rush to use the first domestically-produced equipment. Some existing policies and mechanisms restrict the promotion and application of the first domestic equipment.
The 'first set' problem has become one of the biggest problems for domestic equipment entering the market. This problem has been reflected in the medical device industry in recent years.
In order to solve the problem of the promotion and application of 'the first set' of products, the Ministry of Industry and Information Technology of the People's Republic of China has issued the “Catalogue of the First (set) Major Technical Equipment Promotion and Application Guide” for many years. The Ministry of Finance, the Ministry of Industry and Information Technology and the China Insurance Regulatory Commission jointly launched the first unit in March 2015 ( The piloting of major technical equipment insurance compensation mechanisms will play a role in insurance and reduce the risk of using the first domestic equipment. Many places have also promoted the establishment of the first set of equipment demonstration applications.
However, this is far from enough.
In July 2017, the State Council strengthened the implementation of innovation-driven development strategy to further promote the public Entrepreneurship The “Innovation of the People’s Innovation and Development” (Guo Fa [2017] No. 37) was released. This national document proposes that the NDRC should take the lead to research and formulate opinions on the promotion of the first (set) major technical equipment demonstration application and establish a sound first platform ( Sets) Major technical equipment R&D, testing and evaluation, demonstration application systems, improvement of fiscal, financial and insurance support policies, identification of relevant tendering and procurement requirements, establishment of demonstration application incentive and protection mechanisms, and creation of good policies and market environment.
This time, the “Opinions on Promoting the Application of the First (Set) of Major Technical Equipment Demonstration” jointly issued by the 8 ministries and commissions (hereinafter referred to as the "Opinions") is precisely the implementation of the requirements of the State Council.
According to the Opinions, 'China's major technological equipment development has made remarkable achievements, and it has effectively supported economic development and national defense construction. However, problems such as weak industrial foundation and weak innovation capacity have not yet been fundamentally solved. The first set of demonstration and application equipment has become a problem. The bottleneck of innovation in manufacturing industry development. To implement the implementation of the Party Central Committee and the State Council to advance supply-side structural reforms, implement innovation-driven development strategies, and build decision-making arrangements for manufacturing powerhouses. Use the first set of demonstration applications as a breakthrough to promote major technological equipment levels. As a whole, with the approval of the State Council, the following opinions are now proposed.
The "Opinions" were issued jointly by the central eight ministries, including: National Development and Reform Commission, Ministry of Science and Technology, Ministry of Industry and Information Technology, Ministry of Justice, Ministry of Finance, State-owned Assets Supervision and Administration Commission, State Market Supervision and Administration Bureau, and Intellectual Property Office.
Judging from the background of the “Opinions” and the issuing agencies and wording, the issue of difficulty in popularizing and applying the 'first set of equipment' has been noticed by the central government and has been raised to an unprecedented height. We must take heavy measures to solve it.
32 kinds of medical equipment, into the first set of catalogs
According to the official definition of the Ministry of Industry and Information Technology, the first (set) major technical equipment refers to domestic equipment products that achieve major technological breakthroughs, possess intellectual property rights, and have not yet achieved market performance, including the first three (sets) or batch (sub) complete sets of equipment. Machine equipment and core components, control systems, basic materials, software systems, etc.
A total of a dozen kinds of equipment were included in the “Guidance Catalog for the First(set) Major Technical Equipment Extension and Application” of the Ministry of Industry and Information Technology.
According to the latest release of the 2017 edition of the “First (set) Major Technical Equipment Promotion and Application Guidance Catalog” of the Ministry of Industry and Information Technology, a total of 32 kinds of medical equipment products can enjoy the support of the 'first set' of popularization and application policies.
These products include:
1, superconducting magnetic resonance medical imaging system
2, open superconducting magnetic resonance medical imaging system
38 strong support measures to encourage procurement of the first set of products
In order to promote the demonstration application of the first set of products, the "Opinions" proposed up to 38 specific support measures.
These measures cover a wide range of aspects, among which are clearly stated that priority is given to government procurement and procurement of the first set of innovative products is encouraged. It is also stipulated that, when tendering products included in the first set of catalogs, bidders must not submit market share to them and use them. The requirements for performance, etc., shall not set appraisal standards, technical parameters, etc. for the application of specific products, and may not restrict or exclude the first set of products from participating in bidding under unreasonable conditions.
The following is the specific content of 38 measures:
Second, improve the major technological equipment research and innovation system
(IV) Identify key areas for major technological equipment innovation.
According to the national strategic needs and application requirements, compile major technical equipment innovation catalogs to determine the priorities and timing of research and development. Strengthen the follow-up assessment of catalog implementation, and implement dynamic adjustments. According to the priorities identified in the catalog, it is important to focus on national science and technology major projects and major R&D plans. The implementation of existing technical equipment special projects, in the technological innovation 2030 - major projects and key R & D plans to be launched in the special project, to further strengthen the major technological equipment research and development.
(5) To build a major technological equipment R&D and innovation platform.
Rely on large-scale technology enterprise Group, a key R&D institution, set up a research institute for major technological equipment innovation, oriented towards the development direction of intelligentization, greenization and service, strengthening the top-level design of major technological equipment innovations, and building a major technological equipment innovation system. The State Key Laboratory, Engineering Research Center , Technology Innovation Center, Clinical Medicine Research Center and other national science and technology innovation bases, form a key technology and equipment common key technology research and development platform, gather related resources in the relevant fields, and enhance research and innovation capabilities.
(6) Strengthen cooperation in R&D and innovation of major technical equipment.
Establish a major technological equipment R&D and innovation alliance participated by scientific research institutes, manufacturing companies, industry associations, etc., to strengthen the strength of the main body of innovation, and to promote the cooperation among various types of innovative entities. Establish cooperative mechanisms for cooperation in production, research, and cooperation with shared advantages and shared risks. , Closely focus on application needs, strengthen the convergence of R&D and application, accelerate the demonstration of innovative results. Support R&D, manufacturing, and use of units to establish major technical equipment pilot bases and build bridges between product development and demonstration applications.
(vii) Sound and supportive mechanisms for major technological equipment creation.
Prepare guidelines for the development of major technical equipment for creativity and research, publish research and development needs for the community, and use various innovation models such as crowdfunding, crowdfunding, crowdsourcing and virtual innovation and entrepreneurship communities to gather all kinds of innovative elements and guide the participation of innovative entities such as small and medium-sized enterprises Significant technical equipment R&D. Strengthen the evaluation of creative achievements and the connection between supply and demand, and promote the transformation of results.
(The Ministry of Science and Technology takes the lead, the National Development and Reform Commission, the Ministry of Industry and Information Technology, the National Energy Administration, the National Defense Industry and Technology Bureau, etc.)
Third, improve the first set of test assessment system
(8) Regulate the first set of assessment management.
Formulate the first set of assessment methods, define the first set of definitions, standards, scope, formulate applications, accept, evaluate, publicize, release and other assessment procedures to ensure that the assessment process is open, fair and just. According to the actual development of the industry, determine the first set of assessments Validity period, regularly publish and dynamically adjust the first set of product catalogs passed as a basis for demonstration applications.
(ix) Establish the first set of assessment agencies.
Relying on major technological equipment innovation research institutes, trade associations, and inspection and inspection institutions, etc., we will make full use of existing facilities and platforms to establish the first set of assessment agencies. Assessment agencies will work according to the first set of assessment methods. Formulate the first set of assessment agency management methods. , Clearly assess the scope of the agency's responsibilities, testing and assessment capabilities and other aspects of the requirements. In accordance with the principle of "double random, one open", strengthen post-event supervision, strengthen the credibility of the assessment agency.
(10) To enhance the first set of testing capabilities.
According to the needs of the first set of testing and assessment, the State will strengthen the construction of key laboratories, engineering research centers, technological innovation centers, manufacturing innovation centers, quality inspection centers, and industrial measurement test centers, and improve relevant standards, measurement, inspection and inspection methods and certification systems. Etc., To enhance inspection and inspection capabilities. In industries where process industries and other online testing requirements are prominent, speed up the construction of production test lines and conduct comprehensive system testing on the first set of product quality, safety, environmental protection, and reliability.
(Participated by the State Market Supervision Administration, the National Development and Reform Commission, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the National Energy Administration, the National Defense Industry Bureau, etc.)
Fourth, build the first set of demonstration application system
(11) Establish the first set of demonstration application bases.
Relying on major engineering construction and qualified industry leading enterprises, the first set of demonstration and application bases will be established as the platform for the long-term commitment of the relevant industry's first set of demonstration and application tasks. Overall demonstration and application base construction and related field development planning and implementation, optimization of demonstration applications Base layout. Strengthen the demonstration and application base management and assessment, and adjust the layout of the base in a timely manner.
(12) To set up the first set of demonstration application alliances.
Relying on industry associations and leading enterprises, the first set of demonstration and application alliances participated by users, engineering design, equipment sets, R&D, manufacturing, testing, etc. will be established to build a supply and demand docking platform. The establishment of demonstration application alliances will be encouraged through joint ventures and cooperation. Build a demonstration application production line. Give full play to the integration role of the engineering company and the equipment supplier. Develop and implement the first set of demonstration application program based on the research and development requirements.
(13) Do the first set of demonstration effect evaluation.
Organize the first set of assessment agencies and other units to evaluate the first set of demonstration effects according to the principles of objective reality, transparency, and scientific quantification, sum up experiences, analyze problems, and propose improvement measures. The evaluation opinions can be used as standard revisions, insurance claims , Evaluation, appraisal, awards, etc.
(National Development and Reform Commission takes the lead, the Ministry of Science and Technology, the Ministry of Industry and Information Technology, the National Health and Sanitation Committee, the State-owned Assets Supervision and Administration Commission of the State Council, the State Administration of Market Supervision, the National Energy Administration, the National Defense Industry and Technology Bureau, etc.)
V. Promoting the Fusion of Dual-use Military Technology and Equipment Development
(xiv) Accelerating the advancement of advanced military technologies for civilian use.
Strengthen the transition from the "Catalogue of Transfer of Military Technology to Civil Use" and "The Catalogue of Intellectual Property Transfer of National Defense Science and Technology Industry" to the Innovation Catalog of Major Technical Equipment, and coordinate the promotion of the work of 'Military transfer to civilians'. Gradually expand the National Defense Science and Technology Key Laboratory, the National Defense Science and Technology Industry Innovation Center The degree of openness of military scientific research facilities to the people's mouth units has been accelerated through joint incubation, patent transfer, technology incorporation, and intellectual property trusteeship.
(15) To broaden the participation of Minkou enterprises in the development of military products.
Starting from the actual demand for military product development, we will actively and steadily push forward the 'people's participation in the military' work, through the military equipment procurement system, pricing mechanism and other reforms, promote the development of Minkou enterprises in military product development and support, and encourage military-industrial companies to develop the first set of demonstration applications.
(16) Build the first set of cooperation platform for R&D and demonstration applications.
Establish the first military-civilian dual-use R&D and demonstration application consultation mechanism and cooperation platform to study and promote major issues such as R&D, innovation, transformation of achievements, exchanges and cooperation, and demonstration applications of military-civilian dual-use technologies and equipment. Organize and implement the first set of demonstration application projects. Engineering and so on.
(Ministry of Industry and Information Technology, State Bureau of National Defense Science and Technology, National Development and Reform Commission, Ministry of Science and Technology, Ministry of Finance, State Intellectual Property Office etc.)
Sixth, to strengthen the first set of intellectual property applications and protection
(17) Optimize the layout of intellectual property rights.
For the core key patent applications for the first set of products, priority review support will be given according to law to improve the quality and efficiency of the review, enhance the timeliness of authorization and the stability of patent rights. Strengthen the first set of product and technology intellectual property strategic layout to prevent intellectual property risks. Focus on the first set of industrial chain and value chain to speed up the cultivation of high-value patents. Encourage intellectual property professional service agencies to strengthen the first set of intellectual property services.
(18) To promote the sharing of intellectual property achievements.
In accordance with the principles of risk sharing and benefit sharing, encourage the first set of research and development, system integration, and demonstration applications to share enterprise intellectual property achievements in accordance with the law. Promote the construction of major technical equipment patent pools, guide the establishment of intellectual property alliances in key areas, and strengthen cooperation and exchanges. Collaborative Innovation.
Focusing on major technical equipment, according to the first set of product catalogues that have passed the assessment, we will further strengthen the enforcement of IPR enforcement and severely crack down on IPR infringement and counterfeiting. We will improve the multiple dispute resolution mechanism for IP disputes in major technical equipment and other key areas. Explore the development of mediation of intellectual property arbitration.
(Leadership of State Intellectual Property Office, Ministry of Industry and Information Technology, etc.)
Seven, increase financial support
(XX) Strengthen R&D and innovation support for major technical equipment.
Through the central government's financial science and technology plans (special projects, funds, etc.), the company will support and support the development of major technical equipment and related common technologies that meet the requirements. It will be evaluated and reached the world advanced level in accordance with the guidelines for major technological equipment for the creation of research and development, and will fill the gaps in the domestic market. The results are encouraged to speed up the transformation and application of results.
(21) Focus on supporting the construction and operation of public platforms.
Make full use of existing funding channels, increase support for the first set of related public platforms, and promote the construction and operation of major technological equipment innovation research institutes, key common technology research and development and testing and assessment agencies.
(XXII) Actively support demonstration application bases and projects.
Utilize industrial investment funds and other channels to support the construction of the first set of demonstration application bases and demonstration application projects. Fully-developed infrastructure, comprehensive service standards, effective demonstration application bases and innovations, and the most important set of first-class demonstration applications , Increase support.
(Ministry of Finance leads, National Development and Reform Commission, Ministry of Science and Technology, Ministry of Industry and Information Technology, etc.)
Eight, to strengthen tax policy guidance
(23) To implement the current preferential tax policies.
For enterprises engaged in the R&D and manufacture of major technical equipment, they shall be deducted from the pre-tax deductions of the enterprise income tax in accordance with the current tax policy. If the company is deemed as a high-tech enterprise, the enterprise income tax shall be levied at a reduced tax rate of 15%. The enterprise purchases the first set of products and complies with the regulations. For the current tax policy conditions, tax credits, accelerated depreciation of fixed assets and other preferential tax policies are stipulated.
(24) Adjustment of related import taxation policies.
According to the industrial development situation, adjust the “Guidance Catalogue for Industrial Structure Adjustment.” According to the first set of R&D, manufacturing and demonstration applications, taking into account the needs of domestic industries, and dynamically adjust the “Notice of the State Council on Adjusting the Taxation Policy for Imported Equipment” (Guo Fa [1997] No. 37) Catalogue of "Importable Commodities not Exempt from Taxes for Domestic Investment Projects" and "Catalogue of Import Commodities not Exempt from Taxes for Foreign Investment Projects".
(Ministry of Finance, State Administration of Taxation, General Administration of Customs, National Development and Reform Commission, Ministry of Industry and Information Technology, Ministry of Commerce, etc.)
Nine, optimize financial support and services
(25) Development of Financing Leasing Business.
Implement the requirements for the development of the financing leasing industry, vigorously promote the use of rental purchasing, amortization, etc., improve the market pricing mechanism for the first set of product leasing, promote the first set of demonstration applications through financial leasing, encourage conditional financial leasing, and establish financial leasing companies. The first set of leasing department or professional subsidiary, to better meet the needs of the first set of key areas such as financing leasing.
(26) Strengthening bank credit support.
Encourage qualified commercial banks to establish a first set of green channels for corporate and project loans, build a special credit evaluation system that combines internal and external ratings, optimize approval procedures, increase approval efficiency, actively implement pledges of patent rights, pledge of accounts receivable, etc. • Encourage development-oriented, policy-based financial institutions to provide loan support for eligible first set of demonstration applications within their business scope.
(27) Broadening direct financing channels.
Relying on a multi-tiered capital market system, it supports the first set of corporate asset securitization that meets the requirements. It can meet corporate financing needs through corporate bonds, corporate bonds, short-term financing bills, medium-term notes, perpetual notes, and non-publicly-oriented financing instruments. For the first set of companies to apply for issuance of bonds, to include existing policy support areas, simplify the review process and improve the efficiency of audits. Give full play to the role of advanced manufacturing industry investment funds, national emerging industry venture capital investment guidance funds, and actively attract social capital to participate in the first set of R&D, manufacturing and demonstration applications.
(PBC lead, Ministry of Finance, Ministry of Commerce, Bank of China Insurance Regulatory Commission, China Securities Regulatory Commission, National Development and Reform Commission, Ministry of Industry and Information Technology, etc.)
Ten, enhanced insurance 'stabilizer' effect
(28) Continue to implement the first set of insurance compensation policy.
To sum up the experience of the first set of insurance compensation pilots, to refine and dynamically adjust the first set of guidelines for promotion and application in accordance with national development strategies and market needs. Closely follow the progress of the pilots, do a good job of policy interpretation and publicity, and actively create a favorable policy environment. And social atmosphere, to attract more companies to participate.
(29) Optimize the first set of insurance operation mechanism.
Optimize the operating model and mechanism of the insurance company's co-insurance system, improve the dynamic adjustment mechanism for energy input and output, optimize the accident liability identification process, establish and improve the quick access to claims, accumulate relevant insurance data, continuously optimize the insurance plan, and provide quality services.
(30) Encourage local and insurance agencies to actively explore.
Encourage localities with conditions to combine industrial bases, and independently study and formulate insurance compensation policies, and make distinctions and connections with the country’s first set of insurance compensation policies. Encourage insurance agencies to cover the first set of insurance compensation at the central and local levels according to market demand. Outside the policy, innovation insurance, expand coverage.
(The Ministry of Finance takes the lead, the Ministry of Industry and Information Technology, the Bank of China Insurance Regulatory Commission, etc.)
Eleven, Play the Role of State-owned Enterprises
(31) To implement the responsibility of state-owned enterprises.
We will give full play to the backbone and exemplary role of state-owned enterprises in implementing innovation-driven development strategies and the strategy of building strong countries, and enhance the ability to guarantee the innovation and development of major technological equipment. Strongly promote and actively support state-owned enterprises to participate in key common technology R&D platforms, testing and assessment agencies, The first set of demonstration application bases, demonstration application alliances and other construction, actively adopt the first set of products.
(32) Improve the assessment system.
In the important industries and key areas that are related to the lifeline of the national economy, we will strengthen the national strategy for serving state-owned enterprises, safeguard national security, develop forward-looking strategic industries, and complete assessments for special tasks. The first set of research and development will be applied in performance evaluation. The situation is included in the list of special issues as an important reference.
(33) Establish a fault-tolerance mechanism.
Formulate the first set of demonstration policy on application of negligence and tolerance, reasonably define and appropriately exempt executives, responsible persons from their administrative, economic and security responsibilities, fully mobilize and protect the enthusiasm of applying the first set, and create a favorable environment and atmosphere for supporting innovation.
Focusing on the major technological equipment innovation chain, we will guide and encourage state-owned enterprises or enterprises with other ownerships, and use capital as the link to accelerate mergers and reorganizations. Through strong alliances, complementary advantages, horizontal expansion, and vertical extension, we will vigorously cultivate R&D and manufacturing, and engineering design. Large-scale enterprise group integrating system integration and construction and operation to enhance the capability of innovation and demonstration of major technical equipment.
(The State-owned Assets Supervision and Administration Commission of the State Council took the lead, the Emergency Management Department, the Auditing Department, the National Development and Reform Commission, etc.)
XII. Clear legal requirements
(35) Implementing safeguards related to national security.
According to the relevant provisions of the “National Security Law”, we will further strengthen the building of major technological equipment innovation capabilities, accelerate the development of strategic high-tech technologies that are autonomous and controllable, and key core technologies in key areas. Important industries, major infrastructure, major construction projects related to the lifeline of the national economy In key areas, we will actively carry out and vigorously support the first set of R&D, manufacturing and demonstration applications, encourage the use of the first set of products, strengthen key technologies for influencing or possibly affecting national security, equipping products and services, and strengthen safety review, effective prevention and Resolve security risks.
(36) Strict implementation Bidding Bidding regulations and policies.
According to the first set of product catalogues that have passed the assessment, when the project unit purchases the same type of product at a tender, according to the provisions of Article 41 of the Tendering and Bidding Law, in principle, a comprehensive evaluation method is used for bid evaluation. When the first set of products is submitted for bid The tendering unit may not ask for market share, performance, etc., and may not exceed the actual needs of the bidding project or apply specific product set evaluation criteria, technical parameters, etc. For the first set of products that have been insured, no quality guarantee is generally charged. People, tender proxy Institutions use unreasonable conditions to restrict or exclude the conduct of the first set of bids. Administrative supervisory departments at all levels shall investigate and prosecute their corresponding legal responsibilities according to the provisions of Article 51 of the Tendering and Bidding Law.
(37) Increase government support and other support efforts.
We will improve government procurement policies that prioritize the use of innovative products, adopt first-order purchases and purchases for innovative products such as the first set, and promote the first set of product development and demonstration applications. Other projects that use state funds refer to government procurement requirements and encourage procurement Taiwan sets of products.
(Related departments of the State Council, provincial people's governments are responsible for the division of work according to their responsibilities)
XIII. Establish and implement safeguard mechanism
(38) Strengthen organization and implementation of leadership.
The National Development and Reform Commission and the relevant departments do a good job of coordinating and coordinating the first set of demonstration applications, organizing the implementation, and conducting supervision and evaluation. The relevant departments shall, in accordance with the division of responsibilities, adopt effective and effective policies and measures to ensure the implementation of the tasks. The government combines the actual conditions of the local area to do a good job in organizing the implementation of the first set of demonstration applications in the region.
(39) Improve supporting policies and measures.
According to the overall requirements and key tasks of the first set of demonstration applications, the relevant functional departments took the lead and the relevant departments participated in, and the relevant supporting policies and measures were stepped up. The implementation plan for the promotion of major technological equipment R&D and innovation, testing and evaluation, and demonstration application system construction was formulated as soon as possible. Promote the implementation of the first set of demonstration applications of military-civilian integration, intellectual property, capital, finance, insurance, state-owned assets supervision and other implementation rules or policies and measures, do a good job of national security, bidding and other related laws and regulations interpretation and interpretation.
(40) Strengthen supervision, inspection and evaluation.
All relevant departments should strengthen supervision and inspection of policy implementation and implementation, track analysis work, conduct timely third-party assessments, timely report on important work progress, and issues such as problems. In-depth investigations and researches on emerging new issues should be widely heard. Opinions, propose solutions in a timely manner, and constantly improve the first set of demonstration and application policies.
(41) Establish a consultation security mechanism.
Rely on relevant units to strengthen the first set of relevant strategic planning and policy research for demonstration applications. Give full play to the role of relevant industry associations (societies) and consulting agencies, do a good job in policy interpretation and advocacy, timely reflect the problems in demonstration applications, and propose policy recommendations The use of modern information, network technology and other means to build the first set of demonstration application information service platform to track and study the development of major technical equipment at home and abroad, to provide information services for relevant departments and enterprises.