First, the industry in which the life cycle and the size of the industry
　　(A) Development of China's medical equipment manufacturing industry and the status quo
　　Chinese medical device market demand in recent years, continued growth is expected in the future there is still much room for growth. In recent years, China's medical equipment industry development and investment more active, replacement demand national strategic emerging industries and domestic policy-oriented health care institutions equipment, medical equipment will enable continued growth in the future consumer market.
　　Over the past 13 years, China's medical device market size of 17.9 billion yuan from the 2001 to 2013 growth of 2,120 million, excluding the price factor, 13 years, an increase of 10.84 times. According to Chinese medicine (17.55, -0.560, -3.09%), medical equipment supplies Association branch sampling survey, 2014 annual national medical equipment sales size of about 2,556 billion yuan, more than 2013 of 2,120 billion yuan of 43.6 billion yuan, an increase of rate of 20.57%.
　　The proportion of consumption global pharmaceutical and medical device is about 1: 0.7, Europe and other developed countries has reached 1:1.02, global medical device market has accounted for 42% of total international pharmaceutical market size, and there is a tendency to expand. 2014 China's total medical device market size of about 2,556 billion yuan, the total pharmaceutical market size is estimated to be 13,326 million, medicine and health care spending ratio of 1: 0.19, in 2013 the pharmaceutical and health care spending ratio of 1: 0.2, the next medical equipment market is still room to grow wider.
　　Number of China's medical equipment manufacturing enterprises increased year by year: 2010 is 14,337, of which a class of medical equipment manufacturing enterprises 4015, two types of medical equipment manufacturing enterprises 7906, three types of medical equipment manufacturing enterprises 2416, national and provincial key enterprise supervision 1863. As of the end of November 2012, the number of national medical equipment manufacturing enterprises increased rapidly to more than 16,000, state-owned enterprises, foreign-funded enterprises and joint ventures, private enterprises accounted for 3%, respectively, 37% and 60%. Among them, the output value of enterprises have more than 200 billion; output value of over one billion yuan less than 20 enterprises and foreign-funded enterprises, joint ventures majority. 2011 statistics show that foreign and Hong Kong, Macao and Taiwan invested enterprises constitute the main force of China's medical device industry, accounting for 43% of its assets of China's medical device industry's total assets.
　　Many domestic medical equipment manufacturing enterprises, market concentration is low, according to the geographical distribution is concentrated in Shanghai and Shenzhen as the representative of the East, South coastal domestic brands of medical equipment industry has "more, small, high, weak" features: First First, the production company, as of the end of 2013, there were 15,698 medical device manufacturers; the second is the small-scale enterprises, in 2013 the total output value of the medical device industry market 2,120 billion, the average enterprise value of approximately $ 13.5 million, compared with the previous year increased by 150 million, 12.5%; third is highly concentrated product, medical device products more than 3,500 species, more than ten average for each product registration card; the fourth is relatively well-known international brands, technical level is relatively weak . In recent years, along with manufacturing capability of technology continues to progress and precision manufacturing and mechatronics equipment growing, China's medical equipment industry has developed rapidly. 2000-2012 the size of the medical device industry average increase of more than 20% annually. 2012, China's medical device market has more than 150 billion yuan, China has become Asia's largest producer of medical devices and one of the top ten emerging global medical device market. The next few years, China will surpass Japan to become the world's second largest medical device market.
　　Overall, the medical equipment listed companies have certain advantages of scale, but the industry concentration is still not enough: in 2014, 20 listed companies annual sales in medical equipment production and operation estimated at 37.2 billion yuan, accounting for total industry sales 14.55% the amount. Geographically, China's medical device industry concentrated in the eastern and southern coastal areas. In Shanghai, Jiangsu, as the representative of the Yangtze River Delta region and to Beijing as the representative of the Bohai Bay area is mainly investment in foreign-funded enterprises as the main advantages of industrial clusters are formed. Yangtze River Delta region to disposable syringes and infusion products such as dominant in the country; in Beijing to General Electric Company as the representative of CT machine dominant; Shenzhen medical device industry from scratch, in just over 10 years , China has developed into an important high-end medical device industry, manufacturing and processing base, medical diagnostic imaging equipment, patient monitors and other products in the international market place, the strong development momentum.
　　(Iii) the development of space industry enterprises
　　According Champoux Consulting released the "2011 China Medical Device Industry Analysis and Development Forecast Report" shows that 2015, China's total medical instruments and equipment market is expected to nearly 3,400 billion yuan. The current global medical equipment accounted for 42% of the total pharmaceutical market size, while China's medical equipment total pharmaceutical market size of 14%, a huge potential market prospects. According to the China Association of medical supplies medical equipment branch of statistics, as of December 2013, the domestic medical equipment production licenses held by enterprises 15700, which in the domestic market over 35 medical device. Domestic obtain registration certificate of medical devices medical equipment 93,592 varieties of species, essentially flat year on year, 34,655 kinds of medical devices to obtain a certificate of registration of imported medical devices.
　　China's implementation of a registration system for medical devices, the year 2013 China Food and Drug Administration in November 2014 announced the "Drug statistics", then type Ⅰ, Ⅱ class medical equipment registered a large increase in the number again. Among them, the class Ⅰ re-register a number of 3,738, compared with 2,739 the previous year, an increase of 36.47%; Ⅱ class again registered reached 5,801, more than the previous year increased by 75.79 percent to 3,300 points.
　　China to promote the development of digital medical equipment as well as localization policy orientation is very clear. According to the State Council issued the "" five "national innovation capacity building programs autonomy", the Ministry of Industry and Information Technology issued a "" second five "national strategic emerging industry development plan", "the pharmaceutical industry," second Five Year Plan " "issued by the Ministry of Science and Technology" national "five" science and technology development planning ", advanced medical equipment is an important industry people's livelihood, are key areas of China to develop and cultivate strategic emerging industries," second Five-Year "period, China vigorously promote the development of the core components of medical imaging equipment, key technologies, develop high-end products, foster leading enterprises with strong capability of independent innovation, improve the level of domestic equipment to improve China's medical device industry, international Competitiveness. The series of company products are focused on product development.
　　So far in 2014, the relevant national regulatory authorities have taken positive measures to create a favorable environment for the development of medical device industry: in 2014, the State Food and Drug Administration conducted last five months of "Five rectification" special action, focusing on remediation false registration of medical devices declared illegal production, illegal business, hype, using unlicensed products in five acts, effectively regulate the market, and is conducive to the healthy development of the medical device industry; March 2015, issued by the Ministry of Science and Technology "Digital Clinic equipped with a special focus on the implementation of the program (draft) ", the period 2015 to 2020, the main task of the development of medical device industry, as a major equipment research and development, cutting-edge and generic technology innovation, research, demonstration and evaluation of application solutions. After promoting the development of "second five" period, and the localization of industrial policy and pave the way, the future of China will further increase the digital medical equipment industry policy and investment, "Thirteen Five" during a digital medical equipment industry will achieve a breakthrough and harvest, the future of domestic digital diagnostic equipment will continue its rapid development.
　　The medical imaging diagnostic equipment belongs to the high-end medical equipment, mainly for clinical diagnosis and treatment provide important protection, but also provide an important platform for common medical imaging diagnostic equipment including clinical science: X-ray machines, magnetic resonance imaging (MRI) devices, Computed tomography (CT) equipment.
　　2014 is the medical imaging diagnostic equipment industry an important year of change. Support the national strategic level, and introduced a series of new policies to promote domestic-made equipment used in hospitals to replace imported equipment, coupled with its own technology, personnel and capital accumulation, the domestic medical imaging diagnostic equipment companies are facing major development opportunities. The next few years, the process of localization of medical imaging diagnostic device will be accelerated, driven by the domestic business market has expanded rapidly.
　　Second, industry competition and trade barriers
　　(A) industry competition
　　According to business scale and market share, medical diagnostic imaging equipment manufacturers in the domestic market can be divided into three basic tier, the company is located in the second echelon. The first tier is a multinational medical device companies, including Philips, GE and Siemens; which some enterprises have developed high software products and hardware, integration and marketing capabilities, product line in addition to covering the major medical diagnostic imaging equipment, Other types of medical equipment products are also many achievements. Current first tier multinational medical device companies occupy a high of diagnostic medical imaging equipment market.
　　The second tier is a blue rhyme, safety and health science and technology, Wandong Medical, diving, Mindray Medical, New Huangpu (13.81,0.100,0.73%), the United shadow health, including the outstanding domestic medical device companies, such corporate brand and technology matures, product quality and performance can be comparable with imported equipment, cost-effective and quality service to welcome more and more medical units. They are the main competitors in the industry, products are being converted from analog to digital era. Division I is the digital products, the comprehensive competitiveness ranking in excellent selection of domestic equipment directory eighth.
　　The third tier is mainly technical capacity is weak, more low-end products, less competitive many small-scale medical equipment manufacturing enterprises.
　　(B) the barriers to entry
　　New entrants to the medical device industry enterprises to achieve economies of scale and compete with existing businesses, primarily in the following barriers:
　　1, the barriers to entry
　　Disposable medical products covered by a class II and III medical devices, the State Drug Administration departments to implement stringent medical device manufacturers license and product registration system, new companies entering the industry need to be approved provincial departments Drug Administration In made "medical equipment manufacturing enterprises permit" and "Medical Device Distribution Enterprise License" only after management; In addition, the industry, the company must correspond to the production and sale of medical products after obtaining product registration card. Audit Requirements strict medical equipment manufacturing enterprises, engaged in the second class, third class medical device manufacturing and production enterprises should have adapted to the requirements of production equipment, space and the environment, its production, quality and technical responsible people need to have a qualified professional capacity; the registration of medical devices, the application for registration of a class of medical device companies need to have a qualified quality management capabilities and appropriate resources, should provide full product performance testing reports, and application II, Class III medical devices registered business needs provide product technical report, security risk analysis, product performance self-test report, clinical trials and medical device product registration issued by testing organizations test reports and other information, product trial, registration inspection, clinical trials, product registration and other sectors have more strict standards and regulations.
　　Only under the premise of the enterprise to meet the production environment, the quality of personnel, equipment and other aspects of the configuration requirements of the premise to engage in medical equipment production, and sales of various types of products are required to complete a series of tests, analyzes, clinical trials and through product registration carried out in terms of new entrants into the business with high barriers.
　　2, Technical barriers
　　Medical device industry is a multi-disciplinary, knowledge-intensive, capital-intensive high-tech industry, the industry product is a combination of medicine, biomechanics, medical materials, mechanical manufacturing and other disciplines of high-tech products. Culture products proprietary technology accumulation and research and development capabilities is a long process, general business can not be quickly formed in a short time. At the same time the industry for the production environment, product manufacturing processes and manufacturing equipment has a very high demand, production and processing technology will directly determine the performance and the effect of the product, directly affects the success rate of surgery. For most users, the main production equipment products are tailored to their own production processes, continuous optimization and improvement in the long-term production process. For lack of compliance with the requirements of the process equipment and the lack of long-term accumulation of experience in the enterprise technology is difficult to produce stable quality of qualified products.
　　3, market access barriers
　　Establish a nationwide sales network and service system requires a lot of capital investment, and sales and service network maintenance requires a lot of high product margins as a support; the tender conditions of the health system in general set higher, need many years of good business performance and product quality and perfect after-sales service network, it is difficult for new entrants to enter the bidding market. Sales of medical devices due to the wide geographical coverage, high professionalism, customer dispersion and other characteristics, widely used in the industry the company "Business-based, supplemented by direct" business model sales to end users.
　　In addition to the dealer needs to have a certain financial strength and marketing capabilities, the need to be able to provide specialized services to end users, to help physicians coordinate and solve problems encountered, and these dealers have basic and advance into the current business to carry out long-term and stable cooperation, new companies entering the industry is difficult to find the right dealer team in a short time.
　　In addition, the construction of a sound marketing network system, not only requires a lot of upfront capital investment, but also need a profound understanding of the market and forward-looking grasp the long-term accumulation, as well as continue to create brand value formed for customers, new entrants in a short time can not be cultivate strong marketing channels.
　　4. Personnel barriers
　　Medical device industry is a special high-tech industries, medical products incorporating new technologies in medicine, electronics, automation and control, and other disciplines, lack of technology and research and development capabilities of enterprises difficult to enter. Core technical personnel need to have a comprehensive knowledge of medicine, electronics, automation control, etc., must have many years of practical experience in the same industry; sales staff need to have marketing and product performance, and other aspects of knowledge; difficult to cultivate these talents in the short term.
　　5, financial barriers
　　Medical device industry is a high investment industry, there is no certain scale capital investment in product development and the establishment of sales and service network, enterprises difficult to survive in the market.
　　6, brand barriers
　　Medical equipment related to the life and health of the user, the customer in the choice of products is particularly concerned about the brand, the brand of quality products accumulated over the years, is the new entrants in the short term insurmountable obstacles.
　　Third, the industry and the relationship between the upstream and downstream industry
　　Medical device industry and technological progress, business growth and market expansion are all related upstream and downstream industries are closely linked relationship. Medical device product quality requirements for raw materials is high, demand for more variety and complicated, upstream the medical device industry as materials, electronics, machinery, non-ferrous metals (4248.46,20.930,0.50%) and other industries, upstream industry, technological progress will have a direct impact on medical devices technology trends, such as the upstream industry manufacturing capacity determines the quality of raw materials or semi-finished products, technical level and cost.
　　Downstream of the medical device industry, mainly the final consumer products through hospitals and other medical institutions to the consumer, consumer demand and spending power determines the size of the market capacity, which influence and determine the market prospects and economic benefits of medical products .
　　Fourth, the State of the industry's regulatory system and policy
　　1, the industry department, regulatory system and industry policy
　　(1) the industry department and functions
　　The competent authorities of China's medical device industry is China Food and Drug Administration, its functions include: responsible for the draft regulations and laws of the supervision and management of medical devices, the development of policy planning, formulate regulations and organize the implementation and supervision; responsible for formulating, published medical Device Standards, classification management system and medical device development, production, operation, use and quality management standards and supervise their implementation; responsible for the registration and supervision of medical devices, establishment of medical device adverse event monitoring system, and monitoring and disposal; responsible for the development of medical devices inspection supervision and management system and organize the implementation, organization and investigation of major violations. Establishment issues product recall and disposal system and supervise their implementation.
　　China Food and Drug Administration in charge of the supervision and management of medical equipment, local people's governments above the county level food and drug supervision and management department is responsible for the supervision and administration of medical devices in this administrative region.
　　(2) Industry Regulatory System
　　Medical device industry is one of the state's key management industry. National Development and Reform Commission is responsible for the implementation of the medical device industry, industrial policy, research and develop the industry development planning, guiding industry restructuring and the implementation of industrial management; the Ministry of Health is responsible for the formulation of health reform and development strategic goals, plans and policies, the drafting of laws and regulations related to medical devices The draft, develop medical devices regulations, the development of relevant standards and technical specifications in accordance with law; China Food and Drug Administration is responsible for the development of medical devices, production, distribution and use of administrative oversight and technical management.
　　China's medical equipment industry is currently classified implement supervision and management. Supervision and management including monitoring products, product use and supervision of medical device manufacturers. Oversight products are designed to verify the safety and efficacy of the product. Supervise production enterprises designed to ensure stable product quality, safety and efficacy, manufacturing enterprises is reflected in the audit quality management system, and regularly reviewed. Our review of the quality management system standard for medical devices, the use of the medical device industry standard YY / T 0287-2003 "medical device quality management system for regulatory requirements," equivalent to using the standard ISO13485 "Medical devices - Quality management systems - Requirements for regulatory . "
　　A. Medical Devices category management by risk level
　　① The first type is a low risk level, the implementation of routine management can guarantee their safe and effective medical devices;
　　② The second class is a moderate risk, the need for strict control and management to ensure its safe and effective medical devices;
　　③ The third category is a high risk, we need to take special measures to strictly control and management to ensure its safe and effective medical devices.
　　B. implementation of the medical device product registration and registration management system
　　The first class of medical equipment to implement product record management, and the second class, third class medical device product registration management practice. Accept the application for registration of food and drug administration departments to make decisions based on technical review comments accrediting bodies, for compliance with safety, valid claims are allowed to register and issue a "Medical Device Registration Certificate."
　　① first class medical device products for the record, the record submitted by the person filing the information to the municipal people's government food and drug administration departments seat districts;
　　② apply for Class II medical device product registration, registration applicant shall submit an application for registration information to the provinces, autonomous regions and municipalities food and drug administration departments;
　　③ apply for Class III medical device product registration, the applicant for registration shall submit a registration application materials to the State Food and Drug administration.
　　C. filing medical equipment manufacturing enterprises and production license system
　　① in the first class of medical equipment production, shall be submitted by manufacturers to the municipal people's government food and drug administration departments seat districts;
　　② in the second class, third class medical equipment production, manufacturing production enterprises should apply for permission to the local provinces, autonomous regions and municipalities food and drug supervision and management department. GMP requirements of the food and drug administration departments in accordance with the industry department to develop medical devices for verification. To comply with the conditions of production enterprises, grant permission and issue a "medical equipment production license." In the second class, third class medical device manufacturing companies need access to "Medical Device Registration Certificate" and "medical equipment production license."
　　③ export of medical instruments, the company should ensure that its exports of medical devices meet the requirements of the importing country (region). Class II medical devices in operation, shall be submitted by enterprises to the municipal people's government food and drug administration departments seat districts; engage in Class III medical devices business, enterprises should to the local municipal districts people's government food Drug administration departments to apply for business license, approved and made "medical device companies operating permit."
　　The main laws, regulations and policies (3) where the company involved in the industry are as follows:
　　No.
　　Name
　　main content
　　1
　　Supervision and Regulation of Medical Devices (State Council Decree No. 650)
　　For research in medical equipment, production, sale, use, and supervision and management to make principled provisions
　　2
　　Medical device classification rules (State Drug Administration Order No. 15)
　　To provide for the classification of medical devices specification
　　3
　　Medical Device Manufacturing Enterprise Quality System assessment methods (State Drug Administration Order No. 22)
　　The application of the second Class III medical devices Zhunchanzhuce business review and periodic review of the enterprise make provisions
　　4
　　Medical Device Standards Management (tentative) (State Drug Administration Order No. 31)
　　To provide for standards for medical devices, including national standards, industry standards and registered product standards, to provide for standards work and functions of regulatory agencies, standards development and publishing
　　5
　　Clinical trials of medical devices regulations (State Food and Drug Administration Order No. 5)
　　To provide for the preconditions of medical device clinical trials, rights protection, clinical trials program and other subjects
　　6
　　Medical equipment specification and labeling regulations (China Food and Drug Administration No. 6)
　　The contents of the medical device product brochures, labels, relevant considerations,
　　7
　　Internet Drug Information Services (State Food and Drug Administration Order No. 9)
　　Provide medicines via the Internet to Internet users (including medical equipment) and services activity information.
　　8
　　Production Supervision and Administration of Medical Devices (China Food and Drug Administration No. 7)
　　Medical equipment production supervision and management, regulate the behavior of the production of medical device manufacturing license and record management
　　9
　　Medical management supervision and management measures (China Food and Drug Administration No. 7) Devices
　　Medical device product registration requirements and testing
　　10
　　Medical Registration Regulation (China Food and Drug Administration No. 4) Devices
　　Drug advertising management, to ensure the authenticity and legality of drug advertising
　　11
　　Medical Device Advertising Review Measures (State Food and Drug Administration, the State Administration for Industry and Commerce, the Ministry of Health Order No. 65)
　　Medical equipment advertising standards to ensure the authenticity and validity of drug advertising
　　12
　　Medical Device Advertising Review Dissemination Standard
　　Medical equipment manufacturing enterprises in accordance with the procedure laid down their already marketed defective products, to take measures to eliminate defects behavior.
　　13
　　Medical Device Recall Management (tentative) (Ministry of Health Order No. 82)
　　Production supervision and management of medical devices, medical device manufacturers standardize quality management system
　　14
　　Medical Device Good Manufacturing Practice (Trial) (SFDA [2009] No. 833)
　　Medical equipment production supervision and management, standardized quality management systems of medical device manufacturers
　　Fifteen
　　Medical Device Good Manufacturing Practice inspection Management (tentative) (SFDA [2009] No. 834)
　　Medical equipment production supervision and management data review, site inspection
　　16
　　Medical Device Quality Supervision and random inspection regulations (SFDA Supervisor [2013] No. 212)
　　Medical Device Manufacturing Enterprise routine site supervision and inspection work, unity and thinning-site inspection requirements and methods
　　17
　　Medical Device Manufacturing site daily supervision and inspection work instructions (Food and Drug Administration Office of armed Supervisor [2014] No. 7)
　　Medical device product registration requirements and testing
　　18
　　National long-term science and technology development plan (2006 - 2020) (State Council 2006)
　　Development of major new drugs and advanced medical equipment. Accelerate the establishment and improvement of national pharmaceutical technology platform create, promote independent innovation of major new drugs and medical devices. Focus on the development of new treatments and conventional diagnostic equipment, digital medical technology, medical engineering and individualized equipment.
　　19
　　The decision of the State Council on accelerating the cultivation and development of strategic emerging industries (Guo Fa [2010] No. 32)
　　Accelerate the advanced medical equipment, medical materials and other bio-medical engineering product development and industrialization, promote the large-scale development.
　　20
　　State Council on promoting the healthy development of the service sector (Guo Fa [2013] No. 40)
　　By 2020, the total size of the health service more than 8 trillion yuan, to promote sustained economic and social development has become an important force; foster health-related support services industry to support proprietary pharmaceuticals, development, and manufacturing of medical devices and other health products and applications.
　　twenty one
　　The pharmaceutical industry, "second Five Year Plan" (MIIT January 2012)
　　Key development intervention, radiotherapy, cardiovascular treatment, dental treatment, eye treatment, blood purification, ultrasound therapy and other specialist with medical equipment.
　　twenty two
　　Medical Device Technology Industry "second five" special plan (NSC hair count [2011] No. 705)
　　By 2015, the initial establishment of medical equipment research and innovation chain, the medical device industry technology innovation capacity significantly improved; breakthroughs in key technologies and common core components, focusing on the development of a number of independent intellectual property rights, high-performance, high-quality, low-cost and mainly dependent on imports of basic medical equipment products to meet primary health care needs and the health system in our clinical routine medical needs.
　　Fifth, the favorable factors affecting the development of the industry and unfavorable factors
　　(A) favorable factors
　　1, vigorously support the national policy
　　So far in 2014, the relevant national regulatory authorities have taken positive measures to create a favorable environment for the development of medical device industry: in 2014, the State Food and Drug Administration conducted last five months of "Five rectification" special action, focusing on remediation false registration of medical devices declared illegal production, illegal business, hype, using unlicensed products in five acts, effectively regulate the market, and is conducive to the healthy development of the medical device industry; March 2015, issued by the Ministry of Science and Technology "Digital Clinic equipped with a special focus on the implementation of the program (draft) ", the period 2015 to 2020, the main task of the development of medical device industry, as a major equipment research and development, cutting-edge and generic technology innovation, research, demonstration and evaluation of application solutions. After promoting the development of "second five" period, and the localization of industrial policy and pave the way, the future of China will further increase the digital medical equipment industry policy and investment, "Thirteen Five" during a digital medical equipment industry will achieve a breakthrough and harvest, the future of domestic digital diagnostic equipment will continue its rapid development.
　　National long-term development plans are medical device industry as a key development areas, including the 2006 "Long-term Scientific and Technological Development Plan and" for the first time to write the contents of the medical device industry. With the country's economic strength, many types of research or development funded projects (such as the 863 Program, the state's key projects, industrial projects, etc.), the inclusion of medical materials and products related subjects increased significantly. Country huge investment in research and development of medical materials and products in the field, greatly improve the industry's technology level, shorten product update cycle.
　　In 2011, the Ministry issued "Medical Device Technology Industry" second five "special plan", the "breakthroughs in key technologies and common core components, focusing on the development of a number of independent intellectual property rights, high-performance, high-quality, low costs and mainly relied on imports of basic medical equipment products to meet primary health care needs and the health system in our clinical routine medical needs "into the overall goal of China's medical device development; in 2006, the State Council issued the" National long-term Science and Technology Development Plan ( 2006-2020) "as a guiding document for the development of science and technology, will be" the key to a breakthrough medical devices, with the industrial development of technological capability "into the development objective," disease control center of gravity forward, adhere to prevention, health promotion and disease prevention combined research prevention and early diagnosis of key technology, significantly improve the diagnosis and prevention of major diseases ability, development of advanced medical equipment, medical equipment to promote independent innovation "into the development of ideas, calling for" focusing on the development of new treatments and conventional diagnostic equipment. "
　　2, the medical device market prospects
　　Medical device industry large number of applications of new technologies, new materials cross, involving optical, electronic, ultrasonic, magnetic, isotope, computers and other multi-disciplinary integration, including artificial material, artificial organs, biomechanics, monitoring equipment, diagnostic equipment, imaging technology, information processing, image reconstruction, the first application of a variety of science and technology in medical equipment products.
　　3, the downstream market prospects
　　With the "deepening medical and health system planning cum implementation plan" launched the "Twelve Five" period, new medical reform program to further emphasize the public nature of the medical and health services, efforts to speed up and improve the universal health care system, improve the basic drug system and consolidate grass-roots health care institutions run a new mechanism, actively promote the reform of public hospitals, urban doing the equalization of basic public health services, the configuration of health resources, social capital to do medicine, health information technology, pharmaceutical production and circulation and the medicine regulatory system and other aspects of supporting reforms. According to "deepen the medical and health system reform in 2013 mainly work", the current urban basic medical insurance, basic medical insurance for urban residents and the new rural cooperative medical care covering all urban and rural residents in three basic medical insurance (combined) rate remained stable at 95% the above. End customer belongs to all levels of the industry's main hospital, community or rural health service stations around the CDC and other health services. With the advance of medical reform, China's economic development and the aging intensifies, the downstream industry customers to improve and perfect will provide greater market space for the company.
　　(Ii) unfavorable factors
　　1, foreign companies compete
　　Currently fully grasp the key biological and new materials industry technology is several major foreign medical device companies such as General Motors, Philips, etc. They have developed from upstream to downstream industrial application materials complete industrial chain advantage. In recent years, China's catch-up speed in the field is accelerating, but at present there is not yet fully grasp the companies have the ability to control upstream materials research and development, and to maintain international synchronization of upgrading and innovation. In addition, the ability of domestic enterprises in terms of capital and brand influence and other foreign manufacturers gap significantly.
　　2, the threat of new entrants into the enterprise
　　Medical products higher gross margin level and a huge market growth space will attract more domestic and foreign manufacturers to enter the industry, especially the strength of large enterprises, can rely on its proven market experience and financial advantages by domestic comparable Company mergers and acquisitions of public companies, which occupy or expand its market share in the domestic medical device industry, the intensity of competition in the market. Industry manufacturers to maintain its existing industry leadership, we must increase R & D investment, enhance independent innovation capability, has introduced new products, improve product lines and expand financing channels, by market capitalization and standardized operation, in order to ensure its competition in the market dominant position.
　　3, low value-added products, intense competition
　　Low value-added products, though they have a certain international market share, but little contribution to the development of the industry. Many enterprises have become the overseas market, "manufacturing center", earning low amount of manufacturing costs. In recent years, domestic labor costs coupled with rising medical equipment business operations costs continue to rise, which gives a lot of the survival and development of SMEs has posed a serious challenge. As the industry continues to specification, some small and medium enterprises are more medical devices it is at risk of being eliminated. In the international market, Chinese enterprises are already facing Chinese medical device manufacturing cost advantage gradually weaken or even disappear position; in the domestic market, low cost, low price is the result of intense market competition, the cost advantages of scale enterprises gradually be reflected, more many SMEs face survival and development.
　　4, lack of R & D capabilities, innovation capacity is weak
　　At present, most of the medical equipment manufacturing enterprises lack of technical innovation, research equipment and infrastructure poor conditions, inadequate investment in research and development, scientific and technological achievements into the capability is weak, in the high-end medical equipment, no technology and strength to go beyond multinational and domestic mainstream enterprise, can only take the road of imitation, the price war.