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Beauty five new medical devices of economic growth pole surface
Cosmetic medical device market is a relatively young market, but the development speed. In 2009, the global beauty medical equipment market generated total sales of $ 1.8 billion in 2010, nearly $ 2 billion. According to F & S predicts that by 2016, global beauty medical equipment market will reach $ 4.9 billion, an annual growth rate above 7%.
Of particular note is that in the past few years, although the United States and Europe, economic stagnation, the global beauty medical equipment market remains a growth trend. Western economic analysts speculated that this may be related, including China, Brazil, India and other emerging economies and the European medical device products for the beauty needs of the powerful.
Beauty in the medical device market in Europe and America developed the verge of saturation, the international medical device industry in China, Japan, Korea, Hong Kong, China and Southeast Asia have high hopes
Outstanding contribution to skin care equipment
Medical equipment in the beauty market, a factor can not be ignored is the product of laser beauty equipment skin care equipment to the global rise of a new contribution to the market. Laser beauty equipment is now increasingly used in skin care, cosmetic surgery, removal of scars and birthmarks such as silicone filled breast surgery. These cosmetic surgery for cosmetic medical products of great social demand.
For example, micro-injection of neurotoxins such as botulinum toxin cosmetic surgery has been all the rage, although expensive, but do Botox cosmetic surgery still rush. To this end, designed for injection of botulinum toxin, hyaluronic acid or collagen syringes and other cosmetic drugs, special sales doubled.
There are three major global skin care market – the United States, Europe and Japan, the world\\ s three major markets together accounted for 87% of skin care market. Currently, the only European manufacturer of laser beauty equipment as a key product development, a number of emerging economies will also focus on the development of laser beauty equipment as medical devices. In recent years, with the rapid economic development in East Asia, South Korea and other East Asian countries are now dominated by the skin of the beauty industry to flourish. At the same time, and skin care industry for the production of medical devices have begun to fast track.
In addition, some of the more affluent countries in Southeast Asia such as Singapore and Malaysia, the number of cosmetic surgery to do skin is also rising rapidly, and thus promote skin cosmetic surgery device market in Asia\\ s rapid growth.
It is understood that low-power laser skin cosmetic surgery is the most commonly used equipment products, estimated sales in recent years around the world each year millions of cosmetic surgery on the use of laser products, such as carbon dioxide lasers, ruby ??lasers and newly developed semiconductor lasers and so on.
China has become the world\\ s leading producer of laser products and markets, not only the production of industrial lasers, and lasers can produce a variety of skin care products are the domestic annual production of only medical laser product that is more than 10 million units, the product not only for domestic use, there are some products exported. Statistics show that China can produce international beauty industry-wide YAG (1064nm) laser skin care machine, and a variety of Lipstick CO2 laser surgery required, and all kinds of semiconductor lasers and other medical / cosmetic surgery of the size of the laser product.
In 2010, China laser product sales topped 2 billion yuan mark. Clearly, China and the International Civil laser products and technology gap is narrowing.
Map of the five growth poles emerge
Developed countries in Europe and America the brink of beauty medical equipment market saturation point in the case, the international medical device industry has been China, Japan, Korea, Hong Kong, China and Southeast Asia as a cosmetic medical device market growth of 5 new hot spots and high hopes.
According to the International Medical Device Industry experts predict, although in 2016 the U.S. will remain the world\\ s largest cosmetic medical device market, but China and Brazil will become the world\\ s beauty medical equipment on the market a new growth pole, the two countries to cosmetic medical device market 2016 will reach $ 796 million and $ 572 million; India with its large population and rapid development of the national economy, its beauty medical equipment market in 2016 will increase to $ 200 million. Most of ten countries in Southeast Asia is lagging behind economic development, but analysts remain bullish on foreign economic beauty of the region\\ s medical device market, think of the region\\ s beauty medical equipment market in five years is expected to reach $ 200 million in sales.
Europe as a major traditional medical device market, although most of the country\\ s economic stagnation, but after five years in Europe cosmetic medical device market will exceed $ 1 billion. Japan in recent years suffered a series of strong earthquakes, tsunami and stop economic development and other negative factors, it is estimated the country\\ s beauty market sales of medical equipment after five years than it is now in decline $ 29 million.
Experts also predict that the next five years is expected to maintain rapid growth of beauty and health equipment products are: all kinds of gas / solid / semiconductor laser class cosmetic medical products, they are beauty products, the backbone of the medical device components; followed by a variety of tender cosmetic skin surgery-specific products and equipment for injection of botulinum toxin, hyaluronic acid and collagen-specific drugs such as syringes beauty products, liposuction surgery, special suction machine, optical quantum generators and other products.
Strict management of primary health care sector drug management chaos
The current primary drug supply is the main channel of medical institutions at all levels, and urban and rural pharmacies, which share the majority of medical institutions, drug use. As far as I know, because urban and rural development is uneven, leading medical institutions in rural areas lags behind drug use management, need to increase support and remediation efforts.
Drug use a lower threshold
Operate pharmacies, both require the legal representative of a high school education, but also as a quality person in charge of pharmacy professionals, and hardware and software are put forward higher requirements. \"Drug Administration Law\" and the \"Drug Administration Law Enforcement Regulations\" clearly states: \"the establishment of pharmaceutical retail enterprises above the county level where the enterprise shall be subject to drug regulatory approval and issue of a\" drug business license. \"No\" Drug License \", and shall not operate drugs.\" \"Drug companies have drug regulatory department under the State Council established under this Act,\" pharmaceutical quality management standard \"management drugs. drug regulatory departments of pharmaceutical enterprises in accordance with the provisions of whether the\" pharmaceutical quality management practices \"requirements for certification; qualified for certification and issue certification.\"
The existing laws and regulations on medical institutions to use drugs not specifically establish a licensing system, medical institutions, as long as the health authorities issued a \"medical institution\" you can use drugs. In addition, rural clinics has not been introduced basic drugs catalog, the scope of rural medical institutions, drug use is not restricted, and can be combined with Class III medical devices, compared to the pharmacies, the pharmaceutical use of a lower threshold.
Medication management paid insufficient attention to rural
According to my investigation, a long time, the author of Linzi District, Zibo City, Shandong Province, part of the medical institutions is not enough emphasis on pharmacy management, especially at the township level hospitals, due to funding constraints, a clear preference for funding medical equipment, medicines required for the management relative lack of investment in facilities and equipment. The resulting Drug Administration medical institutions in rural areas was significantly lower than the county Qujiyishang medical institutions and pharmaceutical enterprises. On the other hand, village-level medical personnel from the technical standards of drugs, legal awareness and quality consciousness is generally low, the number of management attention and medicines out of the economic benefits, but they ignore the quality of medicines management. I found during inspections, many rural medical institutions pharmacies, medical supply store or even better than an ordinary pharmacy hardware, software development level is not high, less than to ensure safe and effective clinical use of the basic requirements.
According to the survey, rural towns, especially the lack of pharmacy professionals, many primary health care institutions have non-pharmaceutical professionals working in the pharmacy of the phenomenon, most of the village health posts, private clinics are not equipped with pharmacy professionals. On the other hand, grassroots Food and Drug Administration staff shortage, lack of professionals, not only to face over a wide range, length of medical treatment units, but also to take food, medical devices, health products, cosmetics and other aspects of the regulatory regulatory power is clearly insufficient.
Weak enforcement of relevant laws and regulations
In the author\\ s area, for example, despite the region\\ s medical institutions have implemented a \"Shandong drug use quality management practices\" (GUP) certification, but certification after the drug administration system is still difficult to implement. I checked and found that some medical institutions for drug procurement and acceptance strict, ask the supplier qualification is not timely, product acceptance off useless. In addition, various rules and regulations, such as drug storage, maintenance, a library, deployment, incident handling system is not perfect, especially in rural medical institutions in this regard the following issues are more prominent, drug classification is not clear, stacking does not meet the requirements, display more confusion, the Treasury and the pharmacy does not regularly monitor the temperature and humidity and so on. City dispensaries, mostly open-type-counter sales, and sometimes patients without prescription pharmacy you can buy two types of psychotropic drugs.
Increase policy support
I suggested that all levels of government and relevant departments should increase health funding efforts to urge the rural medical institutions in the use of funds to the pharmacy (storeroom) building tilt, primary health care institutions to improve management of drug storage conditions, shrinking the gap between urban and rural areas, comprehensive primary drugs used to enhance the quality of management.
Relevant departments should formulate laws and regulations, strict drug use permit access to health care institutions to implement the market access system for drug use. As the current drug control laws and regulations only for pharmaceutical production and management to implement strict market access system, whether for medical conditions with the use of drugs, pharmaceutical sector can not be monitored in advance, only after its procurement irregularities, the use of counterfeit investigate the behavior of drugs. Lack of chain of custody, so that medical institutions, pharmaceutical management awareness diluted, an objective to increase the difficulty of combating illegal and criminal acts.
Access to medical institutions, drug use to implement the system, either strictly control market access standards, but also monitoring the implementation of the standard. Drug use from the current access system to establish the feasibility point of view, primarily to administrative regulations or local laws and regulations in the form of setting, on the one hand, new start-up medical institutions must comply with statutory requirements or standards, be permitted to \"use\" of drugs eligible; On the other hand, treatment of existing medical institutions qualified to carry out examination and verification, less than the statutory requirements or standards, do not allow their pharmacy or medical supply store a single set.
Regulate drug use behavior
Grassroots medical institutions, pharmaceutical quality management is a dynamic process, drug purchase, storage, sales of each link should have the statutory procedures, any part of a problem, are likely to affect the quality of medicines. Currently, some provinces and cities to develop a \"medical drug use quality management practices\", but the specification is not obvious, I propose to accelerate the development of institutional pharmacy pace of regulatory laws and regulations, medical institutions, pharmacies for supporting the introduction of penalties for violations of the terms. For example: \"Drug Administration Law\" Article 28 Medical institutions must develop and implement pharmaceutical care system, but did not set the appropriate penalty clauses, resulting in work is often difficult to implement, therefore, necessary to further improve the \"Drug Administration Law,\" the medical agencies responsible for provision of pharmacy law.
In addition, according to law with a primary health care institutions should meet the qualification of pharmacy technicians, strengthening from a drug of continuing education. First, the implementation of pharmaceutical practitioners qualification system. Drugs through pre-service training of employees and must pass the examination, with the Drug Administration issued a \"job card\" before engaging in direct contact with the work; second is to strengthen continuing education, from basic knowledge of drugs, pharmaceutical laws and regulations, Pharmaceutical ethics medicines and other aspects to improve the overall quality of employees; third is to encourage employees to actively participate in pharmaceutical professional and technical titles and qualifications assessment and examination, a fundamental solution to the quality of medical institutions, pharmaceutical employees in question. At the same time, to introduce highly educated, professional pharmacy personnel, and continuously added to the law enforcement team, create and play area, town and village levels and Drug coordinators and members of the role of information, mobilize the masses, to strengthen the primary drug market supervision, strengthen primary drug regulatory power to ensure the safety of mass medication.
Against high-end medical equipment trade
China\\ s medical device market in recent years rapid development, the scale has reached 100 billion yuan, however, the global medical device market has already exceeded $ 300 billion for the domestic market of more than 20 times. The next few years, the global medical device market will be 4% to 6% growth rate.
Menacing giant beachhead overseas to the domestic market, \"going out\" cross-border business wins food has become an inevitable choice. However, in the \"going out\" process, the structure of the low-end products exposed China\\ s inadequate investment in research and innovation, low-tech, low value-added short board. \"Second five\" plan proposed emphasis on structural adjustment and industrial upgrading of enterprises will be able to ensure that the main form of higher profits.
Better opportunities than the export of agents
Overall demand for the international market in good condition, nearly two years, China\\ s exports of medical equipment in the global financial crisis and adverse economic catastrophe, and still maintain high growth.
Health Insurance Association last month, China announced the first half of 2011, China\\ s medical equipment import and export statistics show that exports of medical devices for the first half of $ 7.134 billion, surged 57.34% year on year, slightly less than 2 percent of imports continued to maintain large surplus. \"China\\ s medical device product quality and cheap, in great demand on the international market, continued to drive strong growth in exports of medical equipment.\" China Health Insurance Association Medical Director Cai Tianzhi the case said.
From the export structure, the low-end products still account for the vast majority of color ultrasound diagnostic apparatus, X-ray tomography instrument and other high-end varieties accounted for only 7.49%. In the top 10 export enterprises, foreign investment and joint ventures accounted for 7.
Faced with a huge global market, \"cake\", as the main force of domestic exports of medical devices in the low-end products to compete in the international market in a passive weak position, and its innovation is weak, low export prices, profits vulnerable to raw material prices, exchange rates fluctuations, competitive concern.
\"We have the traditional advantages of medical dressings, etc., are constantly improved in recent years, toward the high-tech direction. Although Mindray, higher-dimensional aspects of domestic enterprises in the export competitiveness of slightly stronger, but on the whole, the domestic shortage of local R & D however, in the future \\ second five\\ during the nation will be more emphasis on R & D enterprise in the development of previous years has accumulated a certain basis, the ability to increase investment in research and development. \"Caitian Zhi said.
In the long term, China\\ s huge potential for development of medical device companies. Analysis of gold that the current integration of the medical device industry is in the development of critical points. Research data show that the global medical device industry growth than the pharmaceutical market, the future will remain 10% to 15% compound growth rate. While the developed countries accounted for 78% of the market, however, developing countries represented by China\\ s rapidly growing market, relying on the accumulation of cost advantage and R & D to enhance the status of the industry chain.
Monita analysis, and market high hopes for the export of pharmaceutical preparations compared to high-end medical equipment export outlook is more optimistic. \"China\\ s high-end medical equipment manufacturers are likely to use low-cost and price advantage, accounting for some of the overseas sales of regulating the market share, and a breakthrough in overseas markets than expected after the results of the contribution.\"
However, the \"accelerated appreciation of the renminbi\\ s impact on export profits more and more obvious, imported inflation to a certain extent, plagued the export of medical devices. Local enterprises should strive to reduce costs, and constantly develop new products, improve the technological content of products to seeking to break through. \"Caitian Zhi said.
Monita analysis also believes that China is still export-oriented, labor supply shortages in the increasingly obvious premise, the inevitable trend of rising labor costs, which means that Chinese industrial enterprises to upgrade and enhance labor productivity and additional value is the only way out.
Force high initial success
Strong enemy arrives, the domestic enterprises poised to break through the sea. The face of foreign investment, \"go down\" to seize the low-end market, the domestic local businesses are also actively \"go to\", \"go.\"
All along, our low-end products because of the high cost of medical equipment in the international market sells. In the low-end exports of medical equipment to maintain the same benefits, while high value-added and high-end medical equipment exports has been growing steadily in the international market has room for development. China Health Insurance Association released data show that in the first half, color ultrasound diagnostic apparatus exports $ 162 million, an increase of 28.03%; X-ray tomography instrument exports $ 158 million, an increase of 23.24%; B-type ultrasonic diagnostic apparatus exports 0.81 billion, an increase of 15.96%.
Neusoft Medical, Wandong Medical, financial and medical Dunlop stronger medical device companies export performance in recent years is remarkable, they have begun to change the situation in the low-end products to high-end market forward to establish overseas marketing channels, open the European market, while continuing to explore emerging markets.
As the leading enterprises of Wandong Medical Devices has begun to dabble in high-end varieties. Previously based on primary health care institutions in low-end products, due to trapped in the government tendering and procurement costs caused by price pressure, significantly lower gross margins. Domestic market share of the first medical X-ray was the main source of profit is Wandong, but the foreign medical equipment giants continue to penetrate eroded gross margins dropped significantly.
Since 2009, Wandong embarked on structural adjustment, in the high-end products continued to increase. In its product mix in 2009, government bidding still half the product has been reduced to less than 1 / 10, the end product and the proportion of high-end products, respectively, about 1 / 3. Wandong to increase the number of DR ﹑ ﹑ Cardiovascular Angiography and MRI of gastrointestinal and other high-end large-scale equipment development and sales efforts, 30 million to 60 million in the end product revenue accounted for nearly 40%, large-scale equipment has been support the company\\ s future growth as the core.
After adjusting to the high-end, product gross margin increased dramatically. Medical equipment gross margin from 31.16% in 2009 increased significantly to 37.08% in 2010. 2011 Daily News revealed that the first half of medical products sales income 290.9792 million yuan, profits 10,411.04 million, gross profit margin 35.78%. Among them, export revenue 15,677,600 yuan, accounting for the main business income of 5.17%. However, Wandong Medical species adjust to high-end is still the main face of the domestic market, expansion into international markets is insufficient.
Domestic open MRI and CT Neusoft also being the leading high-end market force. Neusoft also had major medical business based on the national primary health care sector, introduced from CT, ultrasound, magnetic resonance imaging to the X-ray, ultrasound machine, instrument and electrical products and other suitable areas, county and township primary health care sector of economical low-end medical equipment. In recent years, Neusoft actively pursued high-end medical equipment, new product development.
In April 2009, Neusoft successfully developed China\\ s independent intellectual property rights of PET to obtain market access for U.S. FDA. Last July, PET to obtain a one-time six orders for the U.S. market, Neusoft Medical Equipment to test the water the United States made important breakthroughs in high-end market, but also to break the monopoly of foreign companies in PET. In the same year, Neusoft\\ s NeuViz16 FDA-registered multi-slice CT, to become another access to the global high-end medical products.
Neusoft Medical 2010 annual report, Neusoft Medical Systems business revenue 794 million yuan, an increase of 25.3%, 37.66% gross margin. Among them, the medical equipment export earnings $ 26,030,000, an increase of 38%, mainly due to the rapid growth of exports CT machine.
Neusoft Medical Disclosure in 2011, the company medical systems business revenue 40,169 million, up 27.90% over the previous year, accounting for 17.35% in operating income. Meanwhile, exports revenue of $ 14,820,000, an increase of 86.42%. Outside the company grew revenues 33.36% over the previous year, mainly due to the company\\ s international business and medical software export growth contribution of high-end medical products to gain market approval of medical devices to achieve rapid growth in overseas sales.
Although China\\ s high-end medical equipment varieties in the international market share of a gradual increase, but the overall level of technology and brand products and a far cry from the developed countries, therefore, high-end medical equipment is a fashion trend of foreign monopoly is difficult to change, Chinese enterprises break through the road is still a long way to go.
Looking EU medical device regulations
Because the legal framework for the complex and can not follow up on emerging technologies, and regulations of the Member States in the lack of uniformity in the implementation process and other reasons, the European medical device regulatory rules by the multi-accused. Given this situation, the European Commission in late 2010 published a timetable, plan \"rewrite\" the Medical Devices Directive.
The EU is the world\\ s largest medical device markets. In the 1990s, European economies (EEA, including the current European Union\\ s 27 member states and Norway, Iceland and charged Dunshi stool) for the management of medical devices in accordance with the implementation of three medical device directives, the situation is still very harmonious . Today, the European medical device regulatory rules because the legal framework for complex and can not follow up on emerging technologies, as well as members of a lack of uniformity in the implementation process and by the multi-blame. To this end the European Commission in late 2010 published a timetable, to be \"rewritten\" The Medical Devices Directive. In this paper, the current Medical Devices Directive EEA provides a brief introduction, the future of medical device regulations may be rewritten to describe the content. The article also emphasized the medical device manufacturers in the medical device regulations and the implementation of the reform process in response to the opportunity to influence health care reform legislation.
Medical Devices Directive implementation of the current
The current implementation of regulations for medical devices by the Medical Devices Directive (MDD), Active Implantable Medical Devices Directive (AIMDD) and in vitro Diagnostic Medical Devices Directive (IVDD) three instructions. MDD for those who are not included in the scope of pharmacology for the \"diagnosis, prevention, monitoring, treatment or remission of disease,\" medical device. MDD applies to those designed for implantation in the human body after surgery remained in the body, and the need for the \"non-human body or gravity energy\" supply of medical equipment to work. IVDD is applicable to those \"in vitro use, is used to examine samples taken from the human body\" of medical equipment. EEA Member States in accordance with requirements of national legislation to achieve the goal of these instructions.
No degree of EU cross-border regulatory agencies to implement a comprehensive medical device regulatory authority; Instead, each member of the three directives of the European Union will develop its own regulations, and by national authorities (NCA) to enforce. Members will appoint an independent body (the so-called Notified Body, abbreviated as NB) whether the medical device manufacturers to certify compliance with regulatory requirements. Specific \"conformity assessment\" depends on the type of medical device and its application instructions. Medical devices are divided into four categories according to risk (Class I, Class IIa, Class IIb, ClassIII), divided into categories so that patients consider their degree of physical trauma, and duration of physical contact with other factors. IVD also similarly divided into four categories: a general IVD default level two \"Appendix II\" rating (\"List B\" for moderate risk medical devices, \"List A\" for high-risk medical devices) , and a self-test IVD level (for those ambulatory patients directly for medical devices).
In general, high-risk medical devices need to be more involved in large NB, and has more stringent requirements. The lowest risk level of medical device manufacturers only need to issue a self-declaration of conformity can be, no NB intervention; a higher level of risk will be required for medical devices \"category review\" (ie, the medical device by a NB representative sample of a detailed review); and the highest level of risk for medical devices will require a comprehensive quality assessment, including audit and spot checks NB All medical devices must provide clinical data (low level of risk of medical device manufacturers can By finishing with the goal of medical devices \"equivalent\" of the medical equipment currently available information to satisfy this requirement). In addition, manufacturers must also register their medical equipment, and to deploy a pre-market monitoring system to collect and report information about adverse events. After the completion of conformity assessment, the manufacturer can be certified CE marking affixed on medical devices, medical devices that comply with the EU Medical Device Directive of the basic requirements. Affixed with the CE mark for medical devices only in the EEA Member States for sale.
In recent years, the EU medical device regulatory rules through a series of improvements. In 2007, the adoption of a revised Directive, implemented in 2010, the directive to increase the market for medical devices before the monitoring requirements, increased demand for some of the clinical data standards, and will add to the medical software medical devices the list. In addition, in May 1, 2011, national authorities (NCA) has been asked to the European medical device database (EUDAMED) to submit the relevant product certification, pre-market clinical investigations and monitoring data. The database can only be accessed by NCA and the European Commission to market medical devices will streamline the process. Prior to this, new medical devices in the market, we must individually notify members of the various target markets, and now you can save this step.
Concerned about the current medical device regulation in Europe
Despite all these changes, medical supervision and regulations still face a variety of criticisms. Which most concern is that by the regulatory authority delegated to the NCA and the NB, the European Union Medical Devices Directive left EEA national coordination is very small, leaving the EU member states lack of consistency in policy, so that all member States in implementing NB conformity assessment difficult to reach unity, and accused the medical device manufacturers will then choose the best interests of their own bodies for certification. In addition, the EU medical device regulations are also considered \"fragmented and difficult to follow,\" because the EU medical device regulations and multiple instructions from the two main modification instructions. Other concerns include the lack of NB to evaluate emerging technologies expert, it is difficult to implement the directive for the new technology (such as by the composition of human tissue for medical devices, only for the beauty of implantable devices, and no genetic medical purposes test), EEA\\ s main trading partners more and more medical equipment to the EU regulations need to be better global coordination with the Working Group on Medical Devices (GHTF) combined.
The European Commission also took note of these issues, has announced it will \"rewrite\" Medical Devices Directive. In 2008, the European Commission on changes to the legal system of medical devices, consult the industry members, regulators, health professionals and other health care stakeholders views; and in 2010, and on the amendment a second IVD regulations Consulting; EU Health and Consumer Commission in 2011 held a conference theme of \"change in the European medical device regulations in order to meet future needs.\" Committee was in November 2010 announced the planned schedule, work schedule for 2011 include the European Union Medical Devices Directive will rewrite the legislative agenda for 2012 as the first step.
Reform soon
So far, the proposed rewrite of the Medical Device Directive has not been established details. Commission announced the schedule did not give a specific reform plan, but added to provide a range of possible options, including the use of a more broader directive to replace the MDD and AIMDD, issued a directive to upgrade to replace the current IVDD, and / or by water-based conformity assessment procedures, and clarify the key concepts and terminology and other ways to promote consistency between the EEA countries.
More radical proposals include use regulations (direct binding and applies to all EU member states, does not require implementation by the individual member states, respectively) to replace the current more flexible instruction-based program (allowing members to a variety of ways with its own national legislation to achieve the goal the EU Directive); the establishment of a European health agency (EMA) may be about the same drugs for many countries of the EU centralized regulation of medical device regulatory agencies.
Industry interest groups (such as Eucomed) did not support the current EU medical device regulations make fundamental changes. Although the Directive is still being rewritten to start, but the stakeholders on the Commission\\ s reform plan has been to respond. In February 2011, five large organizations notice (NB) to all agencies issued a notice of voluntary codes of conduct, conduct a detailed description of the NB staff qualifications, determine the rules for the implementation of conformity assessment, and provides guide, so that can better coordinate their NB assessment. Whether to comply with the specifications in the present is voluntary and open to all recognized NB. Compulsory measures are currently still under development, expected to be released in January 2012.
Industry stakeholder groups (such as Eucomed, the European Medical Technology Industry Association) did not support the current EU regulations make fundamental changes in medical devices, although they also acknowledged that existing regulatory mechanism does have room for improvement. Eucomed particularly opposed by the administration before the listing of certification procedures, they think it will lengthen the certification deadlines and increased costs, and may hinder competition and innovation. Eucomed is also opposed to the existing regulations for medical devices through the implementation of EMA concentration of power, because of the involvement of EMA will the certification process may be unnecessarily cumbersome procedures.
Medical professionals also contributed to the implementation of the reform. In January 2011, European Society of Cardiology sponsored a clinical assessment of cardiovascular medical devices policy meeting, and called for the establishment of a separate medical device regulatory system. The Institute was established to promote either a new body, or a designated department is responsible for the EMA. In addition to that attitude outside the European Society of Cardiology, \"British Medical Journal,\" also published in May 2011 article, the text that is difficult to implement in the European style of the U.S. FDA medical device regulatory rules.
2008 and 2010 the results of public consultation to provide more inspiration, because these reforms is likely to be selected into the regulations rewritten. Two results of the consultation that the broad support of stakeholders more closely with the GHTF model remain consistent, including more attention to the risk of IVD medical devices category. From 2010 the reaction of public consultation, the IVD product batch verification requirements and the only organization testing for IVD products continue to be exempt or receive widespread support. There are a handful of people in favor of the direct implementation of consumer genetic testing and performance verification of the requirements for IVD strengthen control. These data also indicate that some people support the use of regulatory bodies to replace command, but such a move would involve an enormous amount of management resource costs.
In this respect, the British pharmaceutical and healthcare products authority (MHRA) has the attitude of particular significance, MHRA management of Western Europe\\ s largest medical device markets. MHRA against EMA more interventional medical device regulation, and also proposed the establishment of an \"established by the elected members of integrated management committee\" to ensure that each Member of the regulatory rules of the understanding and implementation consistent. MHRA also support the adoption of risk-based IVD class system, and \"strong advocate within the organization to maintain the exemption.\" All along, MHRA on to many other details to further explain the lack of willingness to reform do not want to support.
And the expected timetable of events will occur
Taking into account the EU medical device regulations rewrite the huge potential impact of medical device companies should be concerned about the expected timetable to ensure their ability to participate in regulatory reform. Commission in accordance with the timetable, expected to be implemented in the first quarter of 2012, after rewriting the Medical Devices Directive. However, the Committee has so far not provided the final reform bill deadline, the final regulations will be rewritten and the European Union Council of the European Parliament by the audits. Pursuant to the European Commission recently published statistics show that during 2004 and 2009 the legislative approval process, the average duration of about 15 months to 44 months.
At the same time, the Commission is preparing an impact assessment of various reform proposals for the analysis of the costs and benefits of its energy, and requires \"NCA, NB, medical industry, medical staff, patients and other stakeholders through the objective clear advice to submit the motion of these are still under the influence of ideas of information and data. \" However, targeted advice only from a clearly identified target groups expressed a variety of perspectives, \"minimum standards of consultation,\" illustrates the advice in the choice of target groups should be considered \"on the specific experience, expertise or technical knowledge of the needs.\" and must include the views from non-member countries, and ultimately ensure that \"relevant parties will have the opportunity to express their views.\" According to the published timetable, the Commission\\ s medical expert team will \"continue to consult\" stakeholders. Given the potential of these reforms will have far-reaching impact, as more details continue to emerge, medical device manufacturers and other stakeholders should look for opportunities to participate in the regulatory reform process in the past.
China s history of medical informatics education and development status
American Medical Informatics Association (AMIA) President Edward Shortliffe is defined as the concept of medical informatics: Medical Informatics (Medical Informatics) is a rapid development of new cross-disciplinary, with biomedical information, data and knowledge for the study collect, store, display and retrieve inside the law, for our health management, clinical analysis of treatment and knowledge to make decisions and solve problems in science.
Time in development, the definition of medical informatics are also under development. The definition of medical informatics have broad and narrow sense, refers to a narrow view of clinical informatics. Major subject areas on the whole, the medical informatics include clinical informatics, bioinformatics, image informatics and public health informatics in several areas. But in China, due to late start of medical informatics, the concept is still fuzzy state.
History – the evolution of the domestic medical informatics and information science from the Medical
Sign of the development of medical informatics can be traced back to the International Federation for Information Processing (Internationl Federation for Information Processing, IFTP) established in 1967, health-related technical committees. Through continuous development, in 1978 established the International Medical Informatics Association (Internationl Medical Informatics Assciation, IMIA). IMIA International Medical Informatics is the authority of the field organization for medical informatics disciplines, the medical industry information to make a contribution.
China\\ s medical informatics and medical education library and information science and information management are inseparable, the origin of medical information, education and breeding in the 20th century, 60 years later, when many hospitals and medical schools according to the needs of society set medical library professional in-service training. To the early 1980s, the medical library of the actual demand for professionals has been a great class in the pre-medical education and practice of library full verification, approved by the Ministry of Health, in the original Norman Bethune Medical University, Tongji Medical University, China Medical University and Hunan Medical University, set the \"Medical Library and Information Science\", a four-year undergraduate, graduate medical degree awarded.
Medical information science development in the 1990s, with the means to keep the information in the application development in various industries, a number of medical colleges and universities have gradually changed its name to the Department of Library Information Management Department, and set up a \"medical informatics\" the direction of the professional, Some hospitals were also established a single health care management system. According to July 16, 1993 issued by the former State Education Commission \"University undergraduate catalog,\" Medical Library and Information Science have also been adjusted on the name, professional name from \"Medical Information Science (medicine, pharmacy)\" to \" information science (medicine, pharmacy), \"to broaden the professional caliber. This path of medical informatics education laid the foundation for standardization and specialization, and its meaning is self-evident.
In July 1998, the Ministry of Education re-enacted the \"University undergraduate catalog\" directory of the original professional made a new adjustment, will be carried out several similar professional merger and reorganization, the original \"Economic Information Management\", \"Information learning \",\" Technology Information \"and\" management information system \"5 the profession as\" information management and information systems \", under the management category. So on this basis, the medical colleges and universities will be \"medical / health information management professional direction\" in information management and information systems under the re-adjustment of the training program and curriculum.
To the end of 2002, approved by the Ministry of Education, Central South University, the \"Information management and information systems (medical direction)\" professional renamed as \"medical informatics\" professional, professional code 070408W. The first time since the fall of 2003, \"medical informatics\" professional recruiting students, which indicates that China\\ s official medical informatics professional start. At the same time, Nantong University, Nantong Medical College, with the merger officially enrolled \"medical informatics\" professional undergraduate, medical informatics education in China has gradually developed.
The status quo – medical informatics education development in China
Adjust the direction of diversification and professional training, the medical informatics education has become a national medical education and information management as part of the education system. After 2000, with the development of medical science and the ensuing tide of medical reform, medical informatics professionals on a higher more professional requirements, the subject of a strong impact on the development of the wave has already begun.
Looking at the international, the development of medical informatics discipline and orientation gradually reached a relative consensus. \"In China, although the term medical informatics is still relatively new, but our industry has developed in the former, and each hospital has used a variety of information systems, but in academic terms, there are a lot of people do not understand the medical informatics in the end what is still a lot of medical information science with the stigma. \"Peking University Health Science Center, deputy director of Lei Jianbo Information said. \"Now, the internationally recognized academic medical informatics system can be divided into the following interrelated areas – bioinformatics, image informatics, clinical informatics, public health informatics. What is the difference which in the end, is our personnel training in the future must get clear. \"
Of course, the development of medical informatics in a foreign country for 30 years, the country\\ s medical information and education are not standing still. We are very pleased to see that in the period 2000 to 2009, after the filing or approval of the Ministry of Education set the field for medical and health information management and information systems professional and medical informatics professional colleges has increased from 20 4 1980 increased by more than 40 today, the domestic medical informatics education has undergone fundamental changes, began an unprecedented situation.
Research – interdisciplinary research in line with the contents of China\\ s national conditions
New medical reform will be the development of medical informatics put on a new schedule, Chinese Academy of Medical Information Institute on behalf of Tao believe that our medical informatics research in the following aspects.
1 Medical knowledge representation
Through the collection of medical knowledge, systems, and its formal definition; guarantor and the computer understanding of medical knowledge consistency. Such as medical knowledge organization system, classification, subject tables, medical classification, medical body, integrated language system. Medical knowledge organization system is to carry out the study of medical informatics research. At the same time, there is the standard medical data code, medical information retrieval, medical decision support.
(2) health information systems
In China, the use of health information systems to improve health care quality, reduce medical costs, medical and health services as a key element of information systems, creating a huge like the United States health care system. This system has hospital information systems, imaging systems, electronic medical records, health records, regional health information systems, telemedicine and so on.
3 Bioinformatics
Bioinformatics (BioInformatics) since the human genome project, humans and model organisms genome testing produced a large amount of data, based on this situation arising, the research, development or application of computer tools and methods to expand on the biology, medicine , behavioral science and the use of health data, including capture, store, organize, analyze and visualize these data.
4 medical informatics education and training
At present, China has more than 40 colleges and universities have set up a Department of Medical Informatics, degree education mainly by undergraduate and graduate levels of education composed of two, doctoral education is just beginning. Despite China\\ s rapid development of medical informatics education, but with technology development and applications, they are still a very large gap. Especially in the construction of the new medical reform trends driving the digital hospital under the medical informatics educated not only to master the information processing technology, but also to acquire sufficient knowledge of medical science.
Medical informatics education in our country\\ s development is still in its infancy, but it will become all countries, especially the construction of health care an important part. The development of medical informatics in China will take a very long period of construction and exploration, the next step we need to further clarify their own purposes and to develop future goals can be achieved, look forward to its development.
PwC: Chinese medical innovation to catch up with Europe in 2020
\"China, India, Brazil, led by emerging markets innovative medical technology is constantly improved. The next 10 years, innovation in the medical field in emerging markets may be more than developed countries.\" World-renowned accounting firm PricewaterhouseCoopers has released the latest report on \"Medical Technology Innovation Scorecard: competition for the world\\ s leading competition,\" said the emerging markets with their own development, is attracting a growing number of innovative resources and activities in an effort pioneered the development of a new generation of small, efficient and more expensive medical equipment.
Advantage of weakening the United States
PricewaterhouseCoopers in Brazil, China, France, Germany, India, Israel, Japan, Britain, the United States and other nine countries had the ability to adapt to changes of an innovative new, multi-faceted assessment.
According to reports, a large number of case studies that, in the leading position of the United States is losing its global innovation center.
PwC report that: medical technology innovation, the United States is still the world leader status. The next 10 years, the United States will continue to show their strongest ability to lead innovation in medical technology innovation, but the leadership will be weakened.
Over the past few decades, the United States to become a leader in medical technology innovation, there are five pillars of this report the five pillars of the nine countries were evaluated. These five pillars are: a strong economic power, such as new technology applications for compensation; innovative resources, such as academic medical centers; supporting regulatory system; demand and price-insensitive patients; by the venture capitalists and other investors constitute a secondary investment groups.
The report notes that with the innovative features of the change, the ideal innovation system itself is also changing. Some of these changes by the United States itself factors, such as new medical technologies in order to certification by regulatory agencies, the cost is getting higher and higher, the results are more difficult to predict; the medical field more and more emphasis on low cost, high value solution programs; R & D investment is becoming more international. Another change will depend on changes in the market outside the United States, for example: the market for investment in local academic medical centers increased; for research projects; many foreign educated scientists and doctors to return to work; mobile medical technology continues to develop , medical channels to increase; these markets are more focused on providing fast, quality, affordable, effective health care solutions.
Attractive emerging markets
Given these factors, medical technology companies increasingly turn to outside the United States to collect clinical data, registration of new products, new markets, those markets have become more attractive and more conducive to innovation. For example, a great number of innovative products into the U.S. before, first select European markets, 2020 may be selected emerging market countries.
PricewaterhouseCoopers U.S. pharmaceutical and medical device industry executives Maike Si Wan Nick (Mike Swanick) said: \"social, demographic, economic, technological and other changes in the combined effects of medical technology is changing the pattern of the world in many countries around the established to encourage innovation in the system – with reasonable financing channels, the necessary scientific knowledge and the interaction with the patient as long as able to adapt to this rapidly evolving environment, the changes to the company or the entire country will be able to create opportunities. \"
The report predicts, Japan, Israel, France, Britain, Germany\\ s innovation capacity will be reduced, while China, India, Brazil, innovation may be enhanced. Over the past five years, China\\ s fastest growing innovation capability, the future will continue to maintain the momentum of rapid development is expected in 2020 than other developing countries and developed countries in Europe to catch up with the level of innovation.
However, according to the forecast: China, India, Brazil and other markets although large, but not necessarily to become the leading force of innovation in medical technology. Because inadequate intellectual property protection, foreign-funded enterprises operating difficulties in some countries, coupled with factors such as underdevelopment of local supply networks, making these markets less attractive, in its efforts to become a global leader in innovative power of the process will also be affected.
\"At present, China\\ s research output in second place, the university leadership, ranked fifth, with Germany, Japan, Britain and other less.\"
PricewaterhouseCoopers director Christopher Westin medical industry (Christopher L. Wasden) pointed out: the difficulty of entering the Chinese market is still relatively high, approved a long time, only Japan is more difficult than China, which to some extent hindered the new technology market.
U.S. FDA Drug import and export supervision and upgrades medical device
Ernst & Young (China) Advisory Limited released the \"2010 Report of the medical technology industry,\" pointed out that the medical technology industry\\ s performance is better than many industries, but overall business is facing unprecedented challenges.
Investment on China\\ s medical market direction, the changes in European and American market regulatory system, as well as local and foreign pharmaceutical companies, the competitive situation and other issues, we interviewed the Ernst & Young partner Zhang Yi Xuan.
Reporter: whether medical or pharmaceutical products, China\\ s pharmaceutical enterprises \"going out\" effort never changed. Therefore, the U.S. FDA (drug certification system) and other changes it is very important. This case you can tell us about it?
Zhang Yi Xuan: Yes. Europe currently imports drugs, medical devices are becoming increasingly stringent regulatory environment. There are three major changes: First, to encourage innovation; Second, the product safety requirements more stringent. Can not go through clinical trials of new drugs marketed less; three drugs listed in the promotion occurred during \"non-normal, excessive\" measures will be strictly controlled. In general, is a more strict.
The European regulatory system is hierarchical management, compared with the U.S. market, is relatively easy, so some U.S. pharmaceutical companies listed on the choice of the first in Europe before returning to the United States. This, China\\ s pharmaceutical enterprises can learn from.
China is the world\\ s largest exporter of medical materials, medical technology products in the path on the lack of international experience, which is the biggest challenge facing the new products from the government for more stringent medical supervision. America\\ s new health care reform plan will be executed, is expected to be imposed \"medical device tax\" will be on a smaller scale, yet profitable companies bring more negative impact.
Reporter: What are China\\ s future growth potential product or a larger area?
Zhang Yi Xuan: China\\ s medical device market is highly fragmented and disorderly competition, Chinese enterprises in product quality, innovation, etc. there is still much room for improvement.
Remote areas in China, the number of a relative shortage of doctors, in this case, if by virtue of medical devices for remote monitoring of the patient information to the detection point on the ideal, so this part of the market have a greater potential for development.
Reporter: At present, global investment in China\\ s healthcare market is still hot it?
Zhang Yi Xuan: Yes. The western medical technology market in China is very strong investment intentions. After the financial crisis, China and other Asia-Pacific emerging markets leading the global medical technology will become the key areas the industry rebound. Many European and American companies, especially small and medium enterprises, want to enter the Chinese market as soon as possible, come up may not come into
Reporter: What do you think of foreign capital into the Chinese market?
Zhang Yi Xuan: Large multinational companies are increasingly concerned about some of the world, including China, Asia-Pacific market. In the past, multinational corporations to the Asia Pacific region as an important growth market, the purpose is to reduce the production and development costs. But now these companies have further developed the business model, pay more attention to product improvements, to study how to adapt by changing the wider population, and even develop products specifically for the Chinese market.
March this year, GE Healthcare in China, local design and development of new low-end market-specific single-row Brivo CT models available, priced at about $ 2 million or so, only one-tenth of GE high-end products. Siemens Medical Solutions of a high-speed double-helical CT, but the price of two or three hundred million yuan, specifically for rural health care market.
We see the foreign-funded enterprises and compete at the same time, benefit, or the majority of consumers and the market.
China has some of the world\\ s leading international companies, by drawing on foreign experience, make new breakthroughs are possible. Of course, the most important point is the first to demonstrate the value of their products, otherwise it will be controlled by others.
Speed ??up the restructuring of China s pharmaceutical industry the main tasks and objectives
First, the adjustment of product structure
1 implementation of the \"establishment of a national essential drugs on the implementation of the system view\" to meet the growing market of essential drugs needs to increase production to ensure supply. Further regulate the production and circulation of essential drugs, basic drug production enterprises to promote mergers and acquisitions, and promote the basic advantages of business to focus on drug production, to encourage their adoption of new technology, new equipment for technological innovation, improve product quality and supply of essential drugs support capabilities. Main varieties of essential drugs among the top 20 corporate sales market share should reach 80%, to achieve large-scale production of essential drugs and intensive.
(2) In the field of chemical drugs, research and development to meet China\\ s major disease spectrum, multiple disease prevention needs of innovative drugs for more than 10 proprietary drugs to achieve industrialization. Seize the rapid growth of global generics market and the large number of clinical use, the patent medicine sales in the forefront of the opportunities one after another patent expires, generic R & D and technology to accelerate innovation, and cultivate more than 20 internationally competitive drug patent expires new varieties.
3 In the field of biotechnology drugs, to keep pace with the rapid pace of development of biotechnology, research and development control cancer, cardiovascular and cerebrovascular diseases, nervous system diseases, digestive diseases, AIDS and other immune deficiency diseases, genetic engineering drugs and antibody drugs, increase of infectious diseases research and development of new vaccines, for more than 15 new biotech drugs to market.
4 In the field of medicine, upholding both inheritance and innovation, drawing on international experience in the development of natural medicine, Chinese medicine to speed up research and development of secondary priority to the development of medical treatment has advantages in therapeutic areas of drugs, cultivation of 50 or more effective, the material the basis of a clear, mechanism of clear, safe, advanced formulations, quality control and stability of modern medicine. At the same time, promoting national development and industrialization of medicine, folk medicine to promote higher standards of Chinese medicine to strengthen intellectual property protection.
5 In the field of medical devices, demand for the clinical application of a wide range of medical imaging, radiation therapy, minimally invasive, surgical implant, in vitro diagnostic reagents and other products, to promote the core components, the localization of key technologies, training more than 200 with independent intellectual property rights, core technology, to reach the international advanced level, the sales income of more than $ 10 million advanced medical equipment.
Second, the adjustment of technical structure
1 In the field of chemical drugs, promote the use of membrane separation, chiral synthesis, the new crystal, biotransformation of new technologies such as bulk drugs, the use of genetic engineering, cell engineering technology to build new or modified strain of antibiotics, vitamins, amino acids and other bacterial products species, improve quality, productivity, energy conservation and reduce costs. Enhanced release controlled release, transdermal, mucosal drug delivery, targeted drug delivery technologies and other new agents in drug development applications.
(2) In the field of biotechnology drugs, major breakthroughs large-scale, high-throughput gene cloning and protein expression, humanized antibodies and humanized antibodies, the new vaccine adjuvants, large-scale cell culture and protein purification techniques. Accelerate the development of high biological activity, stability, long half-life of oral, pulmonary delivery of new biotechnology drug formulations.
3 In the field of Chinese medicine, according to Chinese characteristics, in order to maximize the effectiveness of drugs, lead small security risk as the objective to accelerate the production of modern technology in the application of traditional Chinese medicine, the promotion of advanced extraction, separation, purification, concentration, drying, preparation and process quality control techniques, focusing on the development of dynamic extraction, microwave extraction, ultrasonic extraction, supercritical fluid extraction, membrane separation, macroporous resin adsorption, multi-effect concentration, vacuum belt drying, microwave drying, spray drying, high efficiency, low energy consumption, carbon emissions from advanced technology. Establishment and improvement of traditional Chinese medicine cultivation (farming), R & D, production standards and norms, promote the use of traditional Chinese medicine and multi-component determination of the overall composition control fingerprint of traditional Chinese medicine combined quality control techniques. Development of modern Chinese medicine, combined with traditional Chinese characteristics, focusing on the development characteristics of the product itself for the new formulations
4 to promote the pharmaceutical industry, information technology, to create drugs based on information technology and medical device R & D platform. Pharmaceutical companies to speed up the construction of management information systems, computer-controlled technology to expand the range of applications in production, improve management and quality control standards. Enhance the critical, core level digital medical equipment.
Third, adjust the organizational structure
Implement the State Council to promote the spirit of corporate mergers and acquisitions, to encourage competitive enterprises to implement trans-regional, cross-ownership mergers and acquisitions and joint restructuring, promoting varieties, technology, channels and other resources to the advantage of corporate concentration. Through the great loss and survival of the fittest in the market competition, economies of scale significantly improve the level and degree of industrial concentration, significantly reduced the number of pharmaceutical companies, pharmaceutical company sales accounted hundred industry-wide sales of more than 50%, the formation of a group of international competitiveness of the industry and a strong leading role in the development of large enterprise groups. Support SMEs to \"specialized, sophisticated, unique, new\" direction, the formation of large enterprises and SMEs division of labor, coordinated development pattern.
Fourth, the adjustment of the regional structure
The eastern coastal areas take full advantage of technology, capital, talent, brands, marketing channels, the advantage of tracking the most advanced technology, focusing on the development of high-tech and high added value, low resource consumption of high-tech products, formed in line with international standards \"long Triangle \",\" Pearl River Delta \"and\" Bohai \"three integrated pharmaceutical production base. Midwest advantage of resources and professional development of the distinctive characteristics of the production base, actively undertake the industrial transfer, prevent the production of chemical raw materials to the environmental carrying capacity of weak regions and low capacity expansion, the formation of east, central and western complementary layout, to promote regional economic coordinated development of medicine.
Fifth, adjust the export structure
Accelerate the transformation of export growth, to seize the world generics market growth opportunities, expand the export of agents, in particular the increase for the United States, Europe, Japan, the world\\ s major pharmaceutical market sales. Screening of finished products with comparative advantages, speed up the registration and production of international quality system certification, establishment of an international marketing channels, to cultivate their own brands. Support qualified enterprises to \"go\", set up agents in foreign investment in the factory, directly to end customers. Through policy guidance and support to promote the preparation of enterprises for more than 50 countries of the GMP certification, preparation in the proportion of pharmaceutical exports reached more than 20%.
Purchase and sale of medical equipment management loopholes medical executives “follow-up before the rot.”
Purchase of medicine, medical devices and equipment purchases, expansion of these hospitals are the main source of corruption in the hospital. Sacked two senior executives from the Food and Drug Administration, to the existing large and small hospital, Wenzhou City, Zhejiang Province recently Integrative Medicine Hospital of former president Jiang stockpiling bribes 677,000 yuan, U.S. dollar 1.7 million, the court sentenced for taking bribes ginger deposit product 8 years imprisonment, confiscation of $ 80,000.
Change medication buy equipment to build the building, \"making money\" regulatory loopholes into a hotbed of medical corruption
Not long ago, Wenzhou City, Zhejiang Province Hospital of Integrated Traditional and Western former president Jiang stockpiling Ouhai bribery case in court for sentencing. The prosecution alleged bribery ginger stockpiling 677,000 yuan, 17,000 yuan dollar facts are established, the court sentenced for taking bribes ginger stockpiling eight years in prison, and the confiscation of $ 80,000.
From Wenzhou City, Zhejiang Province, People\\ s Procuratorate of the news that Jiang Wenzhou keep the plot is the fourth year of the hospital director jailed for bribery, and another six health institutions executives have been prosecuted.
According to the prosecution introduced since March this year, Wenzhou Medical Systems to increase efforts to investigate crimes, the city\\ s health care system for investigation of bribery have been 33 cases of 36 people, including 26 major and 20, investigated the high health care system tube 23, the offeror 11.
A large number of hospital executives\\ successor before the rot, \"falling by the wayside, in the local social repercussions caused a great many people questioned the hospital as a public health agency, how to become a breeding ground for corruption? This issue, the prosecution told reporters.
medical equipment bidding into corruption incidence Zone
58-year-old ginger keep the plot, sacked the former as Wenzhou Integrative Medicine Hospital. The main reason to fall in the hospital medical equipment procurement process accepting a bribe.
It is understood that after July 2005, Wenzhou Hospital of Integrated Chinese and Western medicine through bidding and purchasing a MRI (magnetic resonance) equipment. Hangzhou, a medical equipment sales representative Jiamou found ginger keep the plot, some \"exchange\", in the equipment the day before the tender evaluation, ginger keep the plot will be revealed to the pre-tender Gumou.
\"Gratitude\" Jiamou then \"tribute\" to the ginger stockpiling $ 17,000.
In addition, the hospital clean project for bidding, purchasing items such as spiral CT machine, ginger keep the plot but also for successful enterprises to help more than 60 million in cash, \"stream\" from.
Reporters learned that corruption in the procurement of medical equipment case or, worse, actually by the hospital director, chief of the medical device company tailored technical parameters standard. 2007-2008, Medical Equipment Co., Ltd. Hangzhou Wantai Yueqing two hospitals participated in the bidding, were successfully bid. September 2, in which two bidders played an important role in Yueqing City People\\ s Hospital, director of Golden Globe, Yueqing City Second People\\ s Hospital chief of Shang Dingkun are Yueqing City People\\ s Procuratorate filed for taking bribes prosecution.
According to reports, in 2007, Golden Globe that the hospital to purchase a fully automatic luminometer after immunization initiative this message to the Wan Chung, deputy general manager too bright, so Wantai companies to participate in bidding.
Chung Jin Jianying Liang, general manager of the company (handled separately), after discussions decided to make this business, it will extract the reagents used in the instrument for 8% of the total business volume, to give Golden Globe as a rebate.
Subsequently, the representative of the Golden Globe as the purchaser, using its own powers of will, for the million too technical parameters of a company tailored to the requirements and evaluation in October 2007 when, as a unit in his speech to use when Wan said the company a lot of good things too.
Recommended Wantai from companies to participate in the tender, to use its position to tailor-made for the technical parameters Wantai company requirements, to the final vote, in the golden goal of the one-stop \"services\", Man\\ s got his wish to bid too.
After winning the bid, Wantai company in 2008, and 2009 Golden Globe back 6 times to give a total of 205,000 yuan debit and 4 Chinese cigarettes. Until December 2009, golden retirement, he returned to stop accepting debit.
Prosecutor handling the case told reporters, medical equipment bidding incidence of corruption has become the focus of medical areas. In addition, the field of drug procurement executive of the hospital is \"making money.\"
September 29, 2010, People\\ s Hospital of Wenzhou Dongtou bribery case former president of Gan Shixu first instance verdict, Ganshi Xu was sentenced to 10 years.
Ganshi Xu became the second sentence in prison for accepting bribes Dongtou County People\\ s Hospital. Ganshi Xu\\ s predecessor – Qiu Kexin, also found guilty of accepting bribes on September 16, was sentenced to 5 years.
The prosecution alleged, from 2004 to 2010, Ganshi Xu served as president of People\\ s Hospital Dongtou, Pharmacy Committee Officer, use of office facilities, pharmaceutical agents for the Journal of Clinical Medicine and medical equipment salesman Zhang, Zengmou and others to pursue their interests in the hospital medicine and medical equipment into the bidding process to give help and care, they received 467,000 yuan in cash to send.
Period of time, \"making up the building, leading down to\" the field of infrastructure, corruption is the image of view. Now, this statement became a footnote in the medical system corruption.
First Affiliated Hospital of Wenzhou Medical College, built a new hospital, the results on the \"down\" headquarters office building attached to a former director and chief of the hospital infrastructure Otto Lin Ming.
Recently, Dr. Otto Lin, Ming suspicion of taking bribes 3.972 million yuan was Ouhai People\\ s Procuratorate for prosecution, was indicted along with co-medical equipment vendors Chen Jianmin, Liang Hongguang.
In 2007, Wenzhou Medical College, started with a hospital outpatient and emergency medical technicians Ward Building. Jeong In order to make their business successful, found by Otto Lin Ming Chen Jianmin, 2.4 million yuan as promised to the two commissions. To the incident, Chen Jianmin Zheng has gradually paid 1.65 million yuan to commission, and Dr. Otto Lin, Ming-share from $ 1 million.
Last year, a new hospital with a hospital relocation, but also decorative aluminum bidding insulation materials, Otto Lin Ming-think \"get rich\" opportunities again. This time, he let a friend Liang Hongguang come forward with a company of Beijing Cai agreed, if Otto Lin Ming \"help\" Beijing won the bid, the company should pay to Dr. Otto Lin, Ming, Liang Hongguang $ 1.5 million \"commission.\" But let Dr. Otto Lin, Ming did not expect that, $ 1.5 million \"commission\" has not yet arrived, he had stood on the dock.
Vulnerability to internal management of medical institutions, the main cause of corruption
Wenzhou Municipal People\\ s Procuratorate, the relevant department official told reporters that the crimes committed by the health system is a process of social development in a number of factors contribute to the overall phenomenon.
According to reports, the case exposed the hospital in the engineering contracting, equipment bidding, lack of competition in drug procurement aspects of transparency, arbitrary financial expenses, the lack of strict internal approval procedures and other hospital system of internal management and the existence of many problems is the cause of medical corruption the main reason.
Meanwhile, the health system to implement the president, the Secretary is responsible for the system, excessive concentration of power, but also easy to form a final say of the situation. In the group of medical corruption cases, four were of the hospital, three were vice-president, with the rest hospitals are as Infrastructure Division, Department of Pharmacy, inspection chief, director and other staff, hospital executives hold all of these hospital drugs, equipment procurement and management control over. The lack of monitoring mechanisms, to some unscrupulous pharmaceutical equipment vendors to provide a channel for bribery.
In addition, the prosecutor also suggested that the legal concept of hospital executives lack high incidence of such cases is one of the reasons. Analysis of the case is easy to see, sacked the health care executives have four kinds of twisted mind: First, the comparisons lead to imbalances in mind; the second is \"I have your fishing fishing,\" the herd mentality; Third, since the compensation that active psychological; four get away with the existence of the psychological.
Reporters learned from Wenzhou City People\\ s Procuratorate, prosecutors will work together to build the health system and prevention of such crimes punishment system, the formulation of joint Wenzhou Municipal Health Bureau issued \"on the city\\ s health care system work together to carry out the implementation of prevention of such crimes opinions\", and set up leading group of crime prevention duties. Meanwhile, the medical system for crimes committed by multiple areas of loopholes in the system, each trap.
In the standard procurement bidding processes, the prosecution from the perspective of external legal supervision, to help establish and improve the infrastructure of medical institutions or renovation works, medicines, medical equipment procurement management system. The bidding for procurement of medical institutions set up and working bodies of the lead agency to ensure \"the right of non-operation, the operation is not right\", to prevent the \"mouthpiece\" and the black-box problems.
For the drugs problem in the area of ??procurement, the introduction of new drugs by medical institutions to develop regulations, pharmaceutical equipment procurement method of payment, payment to eliminate the process of purchasing executives and promoters of medical institutions of direct contact with the soil that breeds corruption.
In addition, the prosecution will be combined with the health care structure to create interactive multi-monitoring mechanism, the establishment of bribery file query, and timely information on the information and dynamic, and monitoring, auditing, industry and commerce department to supervise the implementation of joint system. Proposal by issuing a prosecutor, open forums, and other forms of return visit after the case put forward proposals to build a common network of crime prevention duties.
Beijing January to May, the medical device industry exports grew about 44%
January to May, exports grew at 1.8 percent of Beijing\\ s foreign trade situation, the medical device industry exports $ 290 million, an increase of 44.4%. Export of medical devices into the city in a beautiful landscape industry.
medical equipment exports, said industry experts at the red forest, the medical device industry is a typical high value-added industry, with strong growth potential, medical equipment exports rose year after year, on the one hand due to double their own business, \"blood\" ability growing, on the other hand with the expansion of overseas showcase closely related.
To help the city to embrace the medical equipment export business for more orders in 2010, Zhongguancun (000,931) product technology demonstration center in Vietnam. Exhibition center as a shopping center, nearly 300 enterprises in this year round display of their goods, without spending a penny. One half of Zhongguancun enterprises.
Beijing Jing Shen Bo, general manager of Technology Development Co., say so, the original every time he went to Germany to attend the world\\ s leading medical exhibition in Düsseldorf, the company was placed in the hall always around the corner, is the most difficult to come to the location, has also signed a few do a good $ 2000 a small list. The exhibition center, once completed, tourists constantly coming like a flood. He had the sustaining power: \"I reckon at least half a million dollars in revenue.\"
Municipal Commission of Commerce official says, if the self-centered model demonstrate success in Vietnam, we will support industry associations as far as possible replicate this model to other target markets, started the city of Beijing medical device companies brand.