Medical School Pathology, Chapter 2a
Aggrandizement medical devices is own research and development, execute concentration to unite as soon as possible superintend
Chi Hui‘s committee member suggests to rebuild national medical devices coordinates leader group
Civil / Zhan Hongchun
Liu Zhixue
2008 the whole nation on two meetings, concerned cure changes, the second reading, draft resolution of the respect such as policy of sanitation of concerned country sanitation, concerned country medicine, speech that represents a committee member, high density ground sees all at of all kinds media, became the popular topic during two meetings for a short while. And the sound of respect of concerned medical devices, bright however have hear of. Assistant director of institute of information of medicine of academy of medical sciences of committee member of countrywide the Chinese People‘s Political Consultative Conference, China, hold <> concurrently " Chinese medicine gazette " Chi Hui of magazine company president is superintended about administration of medical devices and two draft resolution of technology and industrial development respect, caused two meetings to represent the attention of committee member and news media.
On March 12 afternoon, chi Hui‘s committee member is in place where troops are stationed of committee member of countrywide the Chinese People‘s Political Consultative Conference, accepted a reporter interview.
Problem of medical devices more merit takes seriously
"The patient makes an inspection in go to a doctor when, above all of bring into contact with is all sorts of medical devices, just be medicines and chemical reagents and cure next. And in the disease if the medical devices that there is very main effect in diagnosing appears problem, the life of the diagnostic result that will affect a doctor directly and patient is healthy. Accordingly, the problem of concerned medical devices cannot oversight, country to medical devices from research and development, arrive production, current, apply at to finally all the time clinical the superintendency job that waits for each link, cannot ignore more, this is the chief reason that I pay close attention to medical devices to superintend a problem. " Chi Hui‘s committee member without preamble say.
Be engaged in medical sanitation information for a long time studying working Chi Hui, know the concerned news of industry of many domestic and international medical devices, when speaking of our country medical devices managing the current situation, she says: "One of outstanding issues that superintendency respect of our country medical devices exists are opposite namely administration of medical devices is superintended skimble-scamble, the bull government that is put in move much branch, repeat management and the phenomenon that break up management, cause a country to medical devices from research and development, make, current, use, discard as useless whole process cannot build unified administration to superintend, manage across and vacancy is superintended a few more additionally what caused partial segment on link, the trend that and this kind of problem still has expands further... "
Chi Hui thinks, modern medical treatment and progress of communal and wholesome career more and more rely on the product of medical devices with advanced technology, if be used at the disease precaution, of all kinds equipment that diagnose and treats, appliance and material, the material that is used at emergency treatment and rehabilitation and appliance are waited a moment. Put forward to come true in seventeen big report " two individual people are enjoyed " medium " everybody enjoys sanitation of primary medical treatment to serve " , the strategy that shows our party and governmental attention the people‘s livelihood is decision-making had a more clear cause, the country will build cogent and effective healthy safeguard and medical treatment system, solve the masses to see a doctor problem. The process is here medium, the country is superintended to the administration of product of technology of medical devices than before more important.
"Piece break up " reduce superintendency efficiency
Chi Hui says, as economy growth and modern technology develop, industry of medical devices is swift and violent develop, at the same time health of people opposite life asks also rise increasingly, make medical devices is highlighted increasingly in the action in Medical Protection and sickness prophylaxis and treatment. The preliminary supervisory management of product of our country medical devices already began from 80 time, and execute to the security of medical devices and effectiveness superintend lawfully in the round, after national medicines and chemical reagents supervised administrative system to reform 1998 ceaseless development rises. Carry out a proof through superintendency of nearly 10 years, the country is in to the superintendency of medical devices make sure safety of people medical treatment and industry of stimulative medical devices last it is important that healthy progress respect was developed and positive effect. But also should see our country still remains to perfect to the superintendency of medical devices.
Further explanation says Chi Hui, supervise the State Council of management board according to except national provision medicines and chemical reagents for example " medical devices monitors regulation " carry out supervisory management to medical devices beyond, the country is supervised examine quarantine total bureau and national attestation recognize basis of supervisory management committee " national attestation approves ordinance " , include product of partial medical devices mandatory attestation catalog, the requirement undertakes 3C attestation compulsively, otherwise foreign product prohibits an import, domestic product forbids to leave factory and be sold use. Before product of medical devices appears on the market, basis of bureau of national medicine inspect " medical devices monitors regulation " , through be opposite security of product of medical devices is evaluated, register examine and approve and extend to produce licence definitely, and the 3C attestation that qualitative check branch undertakes to product of medical devices detects requirement and the checkup when registering the item is same, form complete reduplicative attestation.
Be like again at present basis of bureau of national medicine inspect " medical devices monitors regulation " , basically involve a product to the superintendency of medical devices be being made and current link respect, and the safe risk management of very important to medical devices clinical use segment, manage as a result of the branch piece break up those who reach legislation to be short of break, cannot bring into administration effectively to superintend, cause in clinical monitoring of the risk government that uses medium medical devices, quality, standard is reasonable use, the respect such as undesirable incident processing appears the phenomenon of superintendency vacancy.
"Although the State Council was promulgated 2000 " medical devices monitors regulation " , but the characteristic as a result of technology of medical devices and product and the characteristic that use a field, the administration of medical devices is superintended still can involve a country other and active technical code and administrative regulations, for instance attestation of standard of measurement Law, quality, standardization law, country approbates byelaw to wait a moment, accordingly, the relation that I think at present we have not handle good medical devices to superintend code and other and relevant code, mutual join and execute the law division of labor, bring about politics give much door, form the across between different administrative regulations and contradiction, destroyed the earnest sex of national administration and authority, waste national administration resource, at the same time administration of block up state superintends a level rise. " further analysis says Chi Hui.
Integration analysis after above circumstance, chi Hui thinks, although the State Council had made clear the responsibility branch that superintends to administration of medical devices, but solve to problem of across of the function between the branch of the bequeath before system is reformed still not complete, involuntary discharge of urine put the management of bull of a few pairs of medical devices, issue that repeats management, and this kind of problem still has the tendency that expands further. Bull and repeat management to make our country medical devices is in not only production, current reach the meeting in using to encounter repeat attestation, repeat pay each convention charge and technical experiment fee, raised the moving government cost of enterprise and hospital, lengthened product of technology of innovation of our country enterprise to enter the cycle of the market artificially, increased the management risk of the enterprise and cost, affected the rapid development of industry of our country medical devices badly. And, because our country is right medical devices from research and development, make, current, use, discard as useless whole process cannot build unified administration to superintend, created the superintendency vacancy of partial link, be like clinical to be in the superintendency of use medical devices with respect to free outer, make a country right the effect that administration of medical devices superintends is reduced, assure effectively what cannot achieve pair of numerous people interests and healthy security.
Should unite centrally to medical devices superintend
In interview, chi Hui is browsing often the jotter in her hand, to feeling in memory the information such as inaccurate data, data, she turns over check to come out to be being read well and truly, ability can remind reporter record. Chi Hui continues to say, management of the bull in controlling government to our country medical devices, repeated the management, problem that breaks up management to already appealed with concerned management department from academia, guild old. In the meantime, as a result of the government sector " piece break up " , value the influence in cadre door hand overly, not determined to consolidating accredit management centrally, the system did not get policy code all the time whole is harmonious, cause long pull pendency, wasted a large number of management already resource, reduced superintendency efficiency, and raises cost is mixed finally by national sanitation defray the patient is assumed. Accordingly, build our country‘s unified, efficient, scientific medical devices to superintend a system, already extremely urgent.
Base oneself upon puts the objective problem that be in and reality at above, chi Hui offerred 3 proposals --
It is unified to concentration of medical devices superintend, building body of inspect of medical devices is to want to superintend administration of medical devices duty to be centered in to execute the law above all main body, specific issue authority differentiates, with benefit at improving administrative efficiency, aggrandizement executes the law supervisory strength, unified execute the law measure, prevent effectively politics many the door, government order is differ and dispute over trifles each other shuffle.
The 2 demand that are progress of facilities of sanitation of combinative state medical treatment, strengthen administration of medical devices to superintend the legislative job of the respect. Current " medical devices monitors regulation " the part that some need are adjusted and still perfects. Superintend the job to strengthen medical devices, the proposal is adjusted and revise " medical devices monitors regulation " , farther clear medical devices is superintended execute the law main body, it is pair of medical devices from research and development, make, current, use, discard as useless whole process executes unified, concentration execute the law superintend provide a basis, to next making " medical devices controls administrative standard " lay a foundation.
3 it is Qing Dynasty wanting a unit of monthly interest rate the administration powers and authorities of office of service concerned medical devices, straighten medical devices to control the concern between administrative laws and regulations and relevant law laws and regulations,
Medical devices " produce, learn, grind, cure " be out of line
"What I say above is the problem that superintends a respect about administration of medical devices, actually, besides the problem that superintends besides governmental administration, in the respect of research and development of medical devices, also existing harmonious without program, lack, policy is out of line, the problem that resource waits a moment dispersedly. And face these problems, the force of industry of pure support medical devices is inextricability. Rise to national level adjusting control only, by national organization, each ministries and commissions is participated in related, unite a program, coordinate integratedly, cite countrywide strength, sufficient conformity has ability each resource, compose builds a technical innovation system that transcends single trade, ability quickens the development pace of technology of medical devices and industry. In this respect, we are going up century 80 time, once had had very good attempt, gained very valuable experience, so, another my draft resolution is " the proposal that about rebuilding national medical devices coordinates leader group " . " fall in the reporter‘s query, chi Hui‘s committee member begins to turn to another topic.
Chi Hui says, undeniable, the current situation photograph that with sanitation of our country medical treatment the enterprise develops quickly is compared, the development of industry of our country medical devices is far apart, a lot of medical devices in the high-grade on the technology count an import in great quantities. Speak of here, chi Hui provided a group of data to the reporter, she says, 2002, product of our country medical devices imports the forehead to be 1.91 billion U.S. dollor, and to 2007 the forehead of entrance of medical devices of our country rises quickly to 4.28 billion U.S. dollor, year grow about 21% on average. Among them hi-tech is large diagnose with cure equipment entrance forehead is 3.569 billion U.S. dollor, 83.35% what occupy medical devices to import the specified amount, the 80% ～ that take market of domestic congener product 90% . And on the other hand, the equipment of medical devices of medical establishment of broad basic level is very pallet however.
"These high-grade and large medical devices are centered in a few large hospitals undoubtedly, masses sees a doctor to center large hospital naturally also, cause the excessive concentration of medical treatment resource, serious unbalance so, aggravate of shortage of resource structure sex of medical treatment charge expand, it is more difficult also to see a doctor. " Chi Hui continues to say.
Chi Hui says, we also should see, industry of medical devices is across of a many course, knowledge the hi-tech industry with concentrated, concentrated capital, involve field of the many course such as accurate machinery, microelectronics, radiative physics, sound, smooth, magnetism, material, many technologies, the technology is updated fast, the risk is high, market admittance threshold is high. Although at present our country is in,the research of numerous hi-tech domain already gained headway, foster and brought up backbones of large quantities of outstanding science and technology, the rapid development of fundamental industry and relevant industry makes industrial environment is improved greatly; The country is encouraging new and high technology own innovation respect also made a lot of encouragement policy, ministry of science and technology tackles key problem to the technology of medical devices in recent years supportive strength relatively increase substantially; National hair changes appoint also include key of industrialization of new and high technology to support a domain medical devices, the funds strength with larger investment gives support, industry of medical devices obtains delectable breakthrough in the technical innovation of partial technology domain, begin to break technical monopoly of abroad, make industry development shows lease of life. But overall for, the huge demand that the innovation ability of industry of our country medical devices and technical level and facilities of sanitation of medical treatment of contented our country expand is having very big difference, highlight expression to be in, it is technology of industry of medical devices innovation system is diseased, lack the innovation positive result of completely own intellectual property; 2 because most enterprise scope is little,be, condition of experiment of manpower resource, research and development, research and development throws serious inadequacy; 3 as a result of,be system of organization of our country trade piece break up, resource of the technical achievement of other industry, industry fails to be united in wedlock adequately with industry of medical devices, produce, learn, grind, cure innovation chain each other are out of line; 4 it is the resource such as the capital that national support medical devices innovates independently dispersive, repeat, fail to produce due result. Especially depend on sb or sth for existence spends pair of crucial technology, abroad technologies such as core component tall already became restrict trade of medical devices the bottleneck problem that product of new and high technology innovates.
Respecting medical devices is produced, learn, grind, of cure be out of line problem, chi Hui offerred his point of view: "In chain of current industry of medical devices, should the supply and demand in industry research and development two end make adjust: Current, the interest that we are company him foundations more and ability grind first send a product to provide the market, get used to a product to undertake a choose and buy again by medical establishment, this is going up somehow have certain blindness, cannot satisfy clinical need truly. If first by medical establishment will clinical the effective demand that go up puts forward, put forward train of thought of research and development according to clinical and real problem, the design gives plan of research and development, be perfected further by the manufacturing company that has technical actual strength and economic actual strength again next and research and development gives a product, devoted production may be more reasonable. I think, medical personnel of clinical a gleam of, it is the use person of medical devices not just, should be the sponsor of product research and development and innovation more. Be like can such, prevented the blindness in research and development not only, still rose to produce, learn, grind, cure the effective union of each link... "
Chi Hui says further: "Some earlier year, industry of our country medical devices ever was adopted for a time " change a technology with the market " politic, try to adopt advanced technique of as joint-stock as foreign big company, collaboration control, raise product level. But introduced numerous item did not produce such result. After the foreign trader is using the market resource of domestic company, manpower resource to score rich and generous gain, did not transfer its advanced product technology Chinese business, should not say to help Chinese enterprise build national own innovation capacity more. Should not say to help Chinese enterprise build national own innovation capacity more..
Chi Hui says anxiously, from 2005 the left and right sides begins, industry of medical devices entered global technology and crucial part to renew period, make industry of domestic medical devices is facing unprecedented challenge, a few famous businesses that lack technical competition ability already by foreign company annex, among them core problem is the skill of key of medical devices that we lack high-grade and core component.
We once had had precious practice and experience
Analyse above problem, chi Hui summary says: "The case that settles effectively is couldn‘t get to fall in these problems that a moment ago I say, we can this one problem, rise to national level, go seeking the way that solves a problem. Actually, in medical devices natural resources of comprehensive and integrated nation, have own innovation side, we had had corresponding practice already, gained valuable experience. Gained valuable experience..
Chi Hui continues to say, in 20 centuries 80 time metaphase, carry out in the country army turn civilian below big setting of the strategy, to industry of medical devices in national leader development takes seriously below, the national medicine bureau at that time takes the lead established the national medical devices that participates in by the branch such as industry of the academy of sciences, aviation, spaceflight, enginery, shipping, nucleus to coordinate a group, rely on the state-owned resource advantage at that time, concentration is introduced was modelled on products of large quantities of one medical devices, once obtained great skill breakthrough, make the level of medical devices of our country spanned nearly 30 years. Although ability of form a complete set of foundation of industry of our country whole is poor at that time, the product is changed and industrialization job is not perfected, but for the following industry own technology innovation laid certain foundation, among them background of experience is extremely precious.
Chi Hui thinks, government of current our country pays close attention to the people‘s livelihood more, in building effective healthy safeguard and sanitation of primary medical treatment to serve systematic process, be diagnosed to hi-tech and treat instrument equipment purchase, will buy sheet by the country undoubtedly, so, of technology of medical devices and product homebred change development to compare before more important. Accordingly, the industry of medical devices that whether holds to development to paddle one‘s own canoe cannot see his be mixed currently only volume of profit of production value of the following industry, should see its are healthy to the countryman more of the level rise, the main effect that produces to social progress and development place, the far-reaching direct society benefit that should see its can arise and enormous indirect economic benefits.
Chi Hui continues to analyse say: "These year of fact proof that come, if we are not determined, next effort build our country‘s powerful own innovation system, industry of our country medical devices does not have the day that come forward, the medical treatment sanitation of the progress of facilities of medical treatment sanitation of our country, people is healthy safeguard is about to continue to depend on expensive entrance product. This is country and society economically not only cannot susceptive, and still will affect national safety when the country faces sudden incident and great epidemic situation. Accordingly, industry of medical devices of comprehensive program our country grows, increase capacity of integral technology innovation, integrated advantage resource tackles key problem development key component already became the urgent matter that enhances competition ability of industry of our country medical devices further. Because modern medical treatment and communal and wholesome enterprise develop more and more rely on the product of medical devices with advanced technology, if be used at the disease precaution, of all kinds equipment that diagnose and treats, appliance and material, the material that is used at emergency treatment and rehabilitation and appliance are waited a moment... "
The proposal rebuilds development of national medical devices coordinates leader group
"Since our used has had corresponding practice and successful experience, so why don‘t we rebuild ‘ does development of national medical devices coordinate leader group ‘ ? " Chi Hui says, if be organized by the State Council, national hair changes appoint, medicines and chemical reagents of provision of ministry of the Ministry of finance, science and technology, Ministry of Public Health, Ministry of Education, Department of Commerce, state monitors section of academy of medical sciences of management board, the Chinese Academy of Sciences, China, China assist, the branch such as system of unripe ministry of the Chinese Academy of Engineering, total full back, war industry, spaceflight system is participated in jointly.
In the proposal of Chi Hui‘s committee member, this when the main function that involves the national medical devices of more than 10 ministries and commissions to develop harmonious leader panel and task have 4 sides --
It is demand of progress of facilities of sanitation of combinative state medical treatment, the organization makes Chinese medical devices in long-term development strategy;
2 it is harmonious, shift each resource, concentration organizes medical devices of component of great and crucial technology, core tackle key problem development, solve technology of medical devices and the bottleneck problem that the industry develops, fan out from point to area, accelerate promotion ability of own technology innovation;
3 it is to combine compose to build innovation of technology of medical devices to serve platform, offer share technical natural resources, manpower resource, technical experiment resource and service of information natural resources, improve the ambient conditions that medical devices innovates independently, of system of innovation of stimulative industry technology build and of innovation ability rise;
Finally is to should assume research and development of technology of harmonious medical devices, industry to promote, administration is superintended and the hospital equipment standard relation between, the development that is medical devices builds good law and policy environment.
Interview finally, chi Hui‘s committee member says: "The sanitation of primary medical treatment of our country serves to be in progressively to ‘ commonweal sex ‘ transfer, in this process, the national investment that increases respect of research and development of medical devices is problem of a pressing sex. Restore or rebuild this involve many domains, many branches ‘ development of national medical devices coordinates leader group ‘ , its are final the purpose is, make industry of our country medical devices can be in future reachs international level inside 10 years, change current and high-grade product to be relied on almost thoroughly entrance, intermediate the situation that the product basically counts an import, accelerating sanitation of medical treatment of contented basic level to serve orgnaization medical treatment plant layout and change while, charge of effective control medical treatment is excessive grow, for the whole people of our country safeguard service of sanitation of primary medical treatment offers strong technology to prop up. ... "
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