In the field of medical technology and biomedicine, China's competitiveness is not the drugs with large output value, but the traditional Chinese medicine promoted by the state and the spontaneously formed advantageous medical devices.

Every year in large and medium-sized medical equipment exhibitions held in various places, there are a large number of Chinese people active everywhere. Although there is still a big gap between China and the world in many products, this gap has become smaller and smaller with the rise of private medical device companies such as Shenzhen Mindray and Yuyue Medical. Medical devices are undoubtedly an internationalized field in China's medical technology and biomedical industries.

In the domestic market, medical devices are also in the stage of market integration after crazy growth, repeated construction, and vicious competition. Many companies that lack technical content have been eliminated from the market. The power of scale and technology makes the strong stronger.

Faced with the huge Chinese market, multinational foreign-funded medical device companies are reluctant to watch their local competitors grow stronger and stronger, and after lack of competitive strategies, they can only "eliminate" their opponents through acquisitions.

A strong upstream must make an extraordinary downstream. With its unique model, the retail terminal rehabilitation home has grown into an excellent medical device retail terminal under China's new business model in a short period of time, and is constantly strategically deploying.

A complete medical device industry chain that integrates various formats, models and characteristics has been continuously improved. At this moment, it has also ushered in an intensive "promotion period" of industrial policies, and the industrial adjustment has been further intensified, and the future left to the powerful is of course broader.

During this critical period, China Medical Materials Association officially initiated the establishment of a medical device branch after a long period of preparation. After in-depth and extensive industry research, the branch edited and published the "2013 Development Status of China's Medical Device Industry".

This report is mainly composed of six parts: industry macro policy, development overview, main features, existing problems, development overview, and prospect and trend forecast. .

Chapter 2013 Impact of China's Medical Device Policy on the Market

In 2013, China issued few medical device policies, but some policies were revised, which had an impact on the market. At the same time, including the follow-up effects of industry policies before 2013, as well as macro policies such as the new medical reform and the State Council's support for the health service industry, they also have a corresponding impact on the medical device industry.

1. Revise the "Regulations on the Supervision and Administration of Medical Devices", focusing on three major changes

The current "Regulations on the Supervision and Administration of Medical Devices" has not been revised since the first edition was released in 2000, and some clauses are unreasonably formulated, which restricts the development of the medical device industry. The changes in the new version of the regulations include the relaxation of registration review, the addition of green channels for review, and the adjustment of the order of product registration and production site licensing.

In 2007, the former State Food and Drug Administration issued a draft for comments on the "Draft Amendment to the Regulations on the Supervision and Administration of Medical Devices" (hereinafter referred to as the "Draft Amendment"). Public comments. In the past two years, the revised draft has been solicited for comments on a small scale for many times, but it has stopped there.

The reason why the revision of the regulations is "undecided" is closely related to the multiple management of medical devices. However, after the adjustment of national institutions in 2013, the State Administration of Quality Supervision has cancelled the certification function of imported medical devices, so the new regulations can be successfully revised.

The main content of the current regulations revolves around how medical device companies obtain the licenses from the regulatory authorities. Due to the early promulgation time, many issues have not been covered, resulting in many problems in implementation. The new regulations will adjust the order of product registration and production site licensing, from first applying for a production permit and then registering products to one that can be registered first and then applying for a production permit. This means that medical device companies can focus on product R&D and listing without having to spend upfront resources on production plant investment, which will greatly ease the financing pressure of small and medium-sized enterprises and is conducive to innovation.

In addition, the new regulations have also accelerated the progress of the registration review of medical devices. For example, the green channel for review is added. The aforementioned person familiar with the matter said that three types of high-risk medical devices are the main targets for the green channel. At present, most of the high-value consumables on the market belong to the three types of medical devices, and the green channel will speed up the replacement of products. At the same time, some Class III medical devices will be reclassified as Class II, and the regulatory pressure will be eased.

2. After the implementation of the "Specifications for Centralized Procurement of High-value Medical Consumables", the price effect has been reflected in the market

At the end of 2012, the former Ministry of Health of the People's Republic of China issued the "Specifications for the Centralized Procurement of High-value Medical Consumables", which clarified the exploration and implementation of provincial-level centralized bidding for high-value medical consumables such as vascular intervention, and proposed the "promoting procurement with volume, volume" similar to drug bidding. price-linked buying and selling model".

From the national point of view, the centralized procurement of medical consumables at the provincial level is being rolled out on a large scale. Since last year, about ten provincial administrative units have launched unified bidding and procurement of medical consumables. The first rounds of tenders for high-value medical consumables in Zhejiang and Henan provinces, which were implemented first, have an average price reduction of 15% and 25%, respectively.

Behind the provincial centralized bidding, the government's intention to directly control the price of medical devices is highlighted. In addition to the bidding department, the National Development and Reform Commission is also planning to master and clean up the sales prices of medical devices. As early as 2011, the relevant departments issued a draft of the "Interim Measures for the Price Management of Implant Interventional Medical Devices", but due to the strong reaction from the industry shelved.

In July this year, when discussing the management of medical service charges and medical device prices, the Price Department of the National Development and Reform Commission once again proposed to focus on strengthening the supervision of the prices of medical consumables, strictly control the varieties of separate charges, and price control has been imminent.

Three, four ministries and commissions "special support for medical devices" policy

At the beginning of the year, the Ministry of Industry and Information Technology has begun to formulate a work plan to accelerate the development of the medical device industry, mainly some oriented ideas, focusing on the long-term development of the industry, but it has not been issued by the end of October.

On July 17, Wu Haidong, deputy director of the Consumer Goods Industry Department of the Ministry of Industry and Information Technology, said that the special medical device category is the new focus of support this year, which clearly proposes the industrialization of new products and the application of new technologies in the field of medical devices, and the key support objects include mastering core components and key technology medical equipment, etc.

In fact, the National Development and Reform Commission, the Ministry of Industry and Information Technology, the Ministry of Finance and the National Health and Family Planning Commission are working together to formulate the "Industrial Revitalization and Technological Transformation Special Project", and the entire special support fund is 1.5 billion yuan. Among them, the 2013 high-performance medical diagnosis and treatment equipment development project will focus on medical imaging equipment and other fields to realize the coordinated development of upstream and downstream of the industrial chain. The three major areas supported include medical imaging equipment, in vitro diagnostic products, and equipment.

Enterprises that are included in the special project are expected to receive generous subsidies "red envelopes" - support funds of more than 10 million yuan. There have been rumors since July that the Ministry of Industry and Information Technology will soon announce the list of companies to be included in the special project, but the list has not been released until early November.

Fourth, the State Council's "Several Opinions on Promoting the Development of the Health Service Industry" on the policy pull of the medical device industry

On October 14, the State Council issued the "Several Opinions on Promoting the Development of the Health Service Industry", which clearly supports the R&D and industrialization of innovative drugs, medical devices, and new biomedical materials, supports the imitation of expired patented drugs, and supports digital medical products and products. It is suitable for the research and development of products such as health detection, monitoring and health Internet of Things for individuals and families.

my country's health service industry covers a wide range and has a long industrial chain, and medical devices, as the basic supporting industry of the health service industry, show huge development potential and space. Data shows that the market size of medical devices and equipment has reached more than 120 billion yuan in 2011, and the compound growth rate from 2000 to 2010 is about 21.3%. It is expected to exceed 300 billion yuan by 2015. It is worth noting that my country's medical devices only account for 14% of the total pharmaceutical market, which is still far from the proportion of 42% in foreign countries. Nowadays, with the increasing awareness of people's health and the deepening of the reform of the medical and health system, a steady stream of impetus has been injected into the development of the medical device industry.

From the perspective of social structure, the intensification of my country's population aging phenomenon has stimulated the demand for medical devices to a certain extent. At the same time, in terms of policy, following the "Twelfth Five-Year" medical reform plan that "by 2015, the number of beds and services in non-public medical institutions should reach 200% of the total number of medical institutions", the "Healthy China 2020" issued by the Ministry of Health last year. "Strategic Research Report" also clearly pointed out that in the next eight years, seven major medical projects involving up to 400 billion yuan will be launched, of which 109 billion yuan will be used for technical configuration of county-level hospitals. In this context, non-public medical institutions And county-level hospitals will have a substantial increase in the purchase demand for medical equipment, which will well stimulate the development of the medical device industry. With the arrival of industry opportunities, the medical device industry has huge growth potential.

Zhou Rui, director of economic consulting and research at CITIC Construction Investment, pointed out that medical device companies should seize the great development opportunities, increase investment in research and development, accelerate technological innovation, provide the market with high-tech products, break the monopoly of foreign companies, and realize medical devices. Transformation and upgrading of the entire industry chain.

Five, the Ministry of Science and Technology "Medical Device Technology Industry "Twelfth Five-Year" Special Plan (2011-2015) "continuous promotion of the industry

The Ministry of Science and Technology announced the "Twelfth Five-Year Plan for the Medical Device Technology Industry (2011-2015)" in November 2011, which currently plays a positive role in promoting the development of the medical device industry.

The overall goal of the plan is that by 2015, a medical device research and development innovation chain will be initially established, and the technological innovation capability of the medical device industry will be significantly improved; a number of common key technologies and core components will be broken through, and a number of high-performance, High-quality, low-cost and mainly imported basic medical device products meet the needs of my country's primary medical and health system construction and clinical routine diagnosis and treatment needs; further improve the policy environment for scientific and technological innovation and industrial development, cultivate a number of innovative brands, and greatly improve industrial competition The development of medical device technology industry has achieved rapid leap forward.

The plan also puts forward specific goals. For example, in terms of technical goals, it is necessary to break through 20-30 key technologies and core components, and form 200 core patents; make important breakthroughs in several cutting-edge technology fields and form industrial advantages.

In terms of product goals, it is necessary to create 50-80 new types of preventive, diagnostic and emergency medical device products that are urgently needed in clinical practice, focusing on the development of basic equipment and medical materials with large demand, wide application and mainly relying on imports, and actively developing chronic disease screening. New medical device products such as inspection, minimally invasive diagnosis and treatment, rehabilitation and recovery, digital medicine, and nursing.

In terms of industrial goals, it is necessary to focus on supporting 10-15 large medical device enterprise groups, supporting 40-50 innovative high-tech enterprises, establishing 8-10 medical device technology industrial bases and 10 national-level innovative medical device product demonstration applications Base, improve the industrial chain, optimize the industrial structure, increase the market share, and significantly enhance the international competitiveness of the medical device industry.

In terms of capability goals, greatly improve my country's medical device innovation and industrialization capabilities, cultivate and introduce a group of academic leaders and innovation teams, establish 20-30 technology research and development platforms, and build 10 national engineering technology research centers and state key laboratories. , improve my country's medical device standards, testing and evaluation system, play the role of industrial technology innovation strategic alliance, promote the in-depth integration of industry, academia, research and medicine, and effectively ensure the sustainable development of my country's medical device industry.

During the "Twelfth Five-Year Plan" period, we will strive for technological breakthroughs, product innovation, capacity building and application popularization, focusing on the implementation of five tasks: basic equipment upgrades, product breakthroughs, innovation in cutting-edge directions, improvement of innovation capabilities, and application demonstration projects.

The first is the upgrading of basic equipment: closely combined with the urgent needs of the construction of county-level, township, community and other grass-roots medical and health institutions and the upgrading of medical equipment configuration, focusing on supporting a group of medical equipment products suitable for grass-roots level, high reliability, low cost, advanced and practical, Improve the equipment level and service guarantee capacity of primary medical institutions.

Focus on the development of basic equipment such as digital X-ray machines, color ultrasound imagers, immune analyzers, blood analyzers, biochemical analyzers, electrocardiographs, multi-parameter monitors, defibrillators, breathing/anesthesia machines, and blood purification equipment suitable for grassroots , consumables and application solutions, improve product reliability, ease of use, reduce costs, and meet the basic equipment needs of primary medical institutions; accelerate chronic disease screening, general medical care, health management, traditional Chinese medicine diagnosis and treatment, home care, etc. The development of new products, as well as the development of application technologies such as digital medicine, mobile medicine, and telemedicine.

The second is product breakthrough: focus on breaking through the bottleneck problem of localization of equipment and core components, realize the independent manufacture of mainstream equipment, core components and high-value medical materials, break the import monopoly, reduce medical expenses, and improve industrial competitiveness.

Focus on the development of imaging equipment such as 64-slice spiral CT, 1.5/3.0T superconducting MRI, PET-CT, real-time three-dimensional color ultrasound imager, high-definition endoscope; develop automatic tubular chemiluminescence immunoassay system, automatic high-throughput In vitro diagnostic systems and reagents such as biochemical analyzers; development of advanced diagnosis and treatment equipment such as imaging navigation aided diagnosis and treatment systems, real-time conformal intensity-modulated radiation diagnosis and treatment systems, and electrical nerve stimulators; development of interventional stents, artificial joints, artificial blood vessels, bone restoration materials and oral cavity Materials and other high-value medical materials. Focus on breakthroughs in core components such as superconducting magnets, multi-channel magnetic resonance spectrometers, high-resolution PET detectors, large heat-capacity CT tubes, X-ray flat panel detectors, ultrasonic transducers, as well as positioning and navigation technology, weak signal detection technology , electrochemical/biochemical sensing technology, renewable material technology and other key technologies.

The third is innovation in the frontier direction: strengthen the research on new principles, new materials, new methods and new processes, accelerate the breakthrough of cutting-edge technologies and the development of innovative products, and seize the commanding heights of future competition in the science and technology industry.

Actively develop multimodal fusion imaging, molecular imaging, terahertz wave detection, low-dose photon detection imaging, electrical impedance functional imaging, in vivo optical coherence imaging, ultrasound focused diagnosis and treatment, neural interface and stimulation, weak physiological signal acquisition, microfluidics and Micro-nano manufacturing and other cutting-edge technologies; accelerate the development of cutting-edge innovative products such as surgical robots, carbon nanotube CT, non-invasive blood sugar, fully degradable vascular stents, cell tissue-inducing biomaterials, central nervous system regeneration and recovery materials, and new TCM medical devices. Actively promote the development and application of new service technologies such as national health perception, management, and promotion that combine human sensor networks, cloud computing, and the Internet of Things.

The fourth is to improve innovation capabilities: coordinate the layout of projects, talents, alliances, platforms, and bases, vigorously strengthen system, mechanism and management innovation, and effectively integrate advantageous scientific and technological resources through various forms such as industry-university-research medical technology innovation alliances, and systematically build a national medical device. The innovation system greatly enhances the independent innovation capability of my country's medical device industry.

The first is to focus on cultivating and introducing a group of leading talents and innovative teams such as strategic scientists, academic leaders, engineering and technical talents, and young and middle-aged experts with world-leading level. The second is to strengthen the construction of industrial technology innovation strategic alliances, and establish and improve research and development alliances for major products and core components. The third is to strengthen the construction of common technology platforms for medical devices, focusing on the construction of 20-30 technology R&D platforms such as medical electronics, medical imaging, physical diagnosis and treatment, in vitro diagnosis, medical materials, personalized design and manufacturing, and reliability assurance, and build 10 platforms. National Engineering Technology Research Center and State Key Laboratory to strengthen the construction of a strategic research system for medical devices. Fourth, strengthen the construction of regional innovation and industrialization bases, and focus on promoting the construction of 8-10 national science and technology industrial bases.

Fifth, the application demonstration project: with the purpose of "innovative development, benefiting people's livelihood", implement the "innovative medical device product application demonstration project" and "digital medical demonstration project", accelerate the application and promotion of innovative medical device products, optimize the allocation of medical resources, let The achievements of scientific and technological innovation have better served the construction of the medical and health system and benefited the general public. Specifically, it includes the implementation of innovative medical device product application demonstration projects and the implementation of digital medical demonstration projects.

Sixth, the new medical reform promotes the demand for medical devices in the market

In 2009, the new medical reform mobilized the forces of various ministries and commissions, with a clear direction and a clear division of labor, which made the 11 supporting policies more operational. At the same time, it can be seen from each policy introduced that each policy is beneficial to the industry and industry leaders. It is an industry reshuffle, which is conducive to supporting the strong and eliminating the inferior.

The overall goal of the new medical reform is to improve the four major systems, namely, comprehensively strengthening the construction of the public health service system, further improving the medical service system (tertiary medical and health service network in rural areas, new urban medical and health service system), and accelerating the construction of the medical security system (urban employees). Basic medical insurance, basic medical insurance for urban residents, new rural cooperative medical care, urban and rural medical assistance) and the establishment of a sound drug supply guarantee system (national essential drug system), and by 2020, establish a basic medical and health system covering urban and rural residents.

In terms of the state's investment in the new medical reform, the government's health investment jumped to 600 billion yuan in 2009, doubling year-on-year; from 2009 to 2011, the incremental investment increased by 77% compared with the stock, and the total investment in three years will reach nearly 2 trillion yuan. An increase of 850 billion yuan. The total health expenditure accounts for more than 5% of GDP, and the proportion of government investment will rapidly jump to 38%.

Driven by the new medical reform policy, the market demand for medical devices has been further released.

7. The adjustment of government bidding and procurement policy brings potential opportunities for the development of local medical devices

In September 2011, the Ministry of Health decided to carry out pilot work on centralized procurement of high-value medical consumables for medical institutions in 8 provinces and cities including Beijing, Tianjin, Liaoning, Shanghai, Zhejiang, Hubei, Guangdong and Chongqing. Consumables, including guide catheters, stents, guide wires, balloons, arterial sheaths, pressure pumps, etc., pacemakers, artificial joints, knee joints, etc. More than 90% of these medical consumables are imported varieties.

In June this year, officials from the National Health and Family Planning Commission and the Ministry of Industry and Information Technology stated that domestically produced medical devices will be the focus of national support this year. It is necessary to strictly implement the government procurement law to ensure that financial funds give priority to the procurement of domestic medical equipment.

It is understood that since 2008, my country has carried out research on the medical device industry, and currently has the basic information. The current characteristics of the domestic medical device industry are: small batches, but high profit margins; products with public product attributes, which belong to the scope of government payment; the industry's high-tech industry features are obvious, the innovation speed is very fast, and it has received a lot of policy attention.

During the "Twelfth Five-Year Plan" period, my country will vigorously improve the digitization, intelligence and networking of medical devices, and promote the development of domestic medical devices.

8. Guiding Opinions of the China Food and Drug Administration on Further Strengthening the Construction of the Monitoring System for Medical Device Adverse Events

The document number of the opinion issued by the CFDA on October 8 this year is "Food and Drug Administration [2013] No. 205", the purpose of which is to further strengthen the monitoring of medical device adverse events, improve the adverse event monitoring system, and establish and improve monitoring at all levels. System working mechanism, comprehensively promote the construction of monitoring system, effectively improve monitoring, evaluation and risk early warning capabilities, and effectively ensure the safety of public equipment.

Strive to establish and improve medical device adverse event monitoring technical institutions and monitoring networks at all levels within about three years, improve monitoring mechanisms, implement monitoring responsibilities, improve monitoring systems, standardize monitoring work, further expand monitoring coverage, explore sentinel monitoring models, and gradually Establish monitoring sentinel points to significantly improve risk early warning capabilities and form a relatively complete monitoring system for medical device adverse events.

The focus of the work is to establish and improve institutions, improve three mechanisms, improve three systems, and achieve three coverages. Among them, 2013-2014 is the stage of construction and improvement, and 2015 is the stage of deepening and improvement.

9. Notice of the General Office of the State Food and Drug Administration on Issues Concerning the Supervision of Small Medical Oxygen Inhalers

The notice issued by the CFDA on September 16, with the document number of "Food and Drug Administration Measures [2013] No. 63", aims to further regulate the production and operation of small medical oxygen inhalers and strengthen quality supervision. There are only three items:

First, for small medical oxygen inhalers that do not contain medical oxygen, continue to be approved as Class II medical devices.

The second is that the filling of medical oxygen in small medical oxygen inhalers is included in drug supervision. Pharmaceutical manufacturers holding an oxygen approval number shall produce and fill oxygen in accordance with the registered process flow under the GMP requirements of pharmaceuticals.

The third is to continue to strengthen the supervision of small medical oxygen inhalers and medical oxygen. For the production and operation of small medical oxygen inhalers that violate the laws and regulations on the supervision of drugs and medical devices, it is necessary to increase the investigation and punishment of cases to ensure the safety of the public's medical devices.

X. The State Food and Drug Administration Solicits Opinions on the Regulations on Sampling and Inspection of Medical Device Quality Supervision

Released by CFDA on July 19, the "Regulations" pointed out that food and drug administrations at all levels should formulate an annual sampling inspection work plan according to the needs of medical device supervision, provide the necessary funds and support guarantees, and publish the sampling inspection results in a timely manner. The sampling unit shall not refuse sampling without justifiable reasons. If the sampled unit needs to assist in sending samples, the sampled unit shall assist.

When the food and drug supervision and administration department conducts medical device sampling, it shall be carried out by more than 2 (including 2) medical device supervision and sampling personnel with law enforcement qualifications. During the sampling process, supervision and inspection of the sampled units shall be carried out in accordance with the law.

If the sampling unit or the labeling manufacturer has any objection to the inspection results, it may apply for re-inspection to the medical device inspection agency with corresponding qualifications within 7 working days from the date of receipt of the inspection report. will no longer be accepted.

If the sample does not match the records on the "Medical Device Sampling Record and Voucher", the inspection agency shall verify with the sampling unit, and the sampling unit shall make corrections. Inspection work shall not be carried out for those that do not meet the relevant inspection regulations, and the results shall be reported to the organization unit.

If the sampled sample does not belong to the sampling scope specified in the annual sampling inspection work plan or does not meet the sampling inspection requirements, etc., the inspection agency shall contact the sampling unit to confirm and arrange for the return of the sample within 5 working days of receiving the sample. The sampling unit shall draw supplementary samples according to the annual random inspection work plan and transfer them to the inspection agency in time.

The "Regulations" also require that inspection agencies should establish relevant systems in accordance with inspection and testing requirements, carry out inspection work, and issue scientific and effective inspection reports in a timely manner. The original records and inspection reports shall be kept for a period of not less than 5 years.

The "Regulations" also require that after receiving the inspection report of unqualified medical device products, the local food and drug supervision and administration department shall conduct supervision and inspection on the relevant production, operation enterprises and user units. Take control measures for substandard products found in supervision and inspection, and investigate and punish illegal acts according to law. If the inspection agency falsifies inspection results or issues false certificates, it shall be dealt with in accordance with the "Regulations"; if it violates discipline and discloses inspection results and publishes inspection results, the relevant responsible personnel shall be given administrative sanctions.