The reflection that new structure of competition of industry of medical devices brings

Medical Terms

Digital technology already made the technology of “ mainstream ” of medical devices. In recent years, the transnational corporation such as riverside of flying benefit of Xi Menzi of American GE, Germany, Holand passes ceaseless and integrated medicine video equipment medium and small businesses, build its the powerful position in industry of medical devices. The personage inside a few course of study offers a kind of view even: In digitlizing technical tide, industry of medical devices began to digitlize “ to encircle ground motion ” . Can foreknow, the digitlization technology that owns intellectual property will be the core competition ability of industry of medical devices, and this kind of competition is not simple technology is modelled on to be able to follow go up.



Progress is sought in advantage butt joint



Industry of digitlization medical devices is considered as 21 centuries to have one of sunny industries of foreground most. According to the material that Manufacturers Association of industry of sanitation of American medical treatment publishs, equipment of global digitlization medical treatment is annual sale is 60 billion dollar about, year amplitude is about 10% . The market of equipment of digitlization medical treatment of our country is not small also, according to estimation, to 2015, our country digitlizes market of medical treatment equipment to will exceed 150 billion yuan of RMBs. Permit much transnational corporation, wait like riverside of GE, Xi Menzi, flying benefit, Toshiba see market of our country medical devices ” of cake of this big “ , thick as hail. They base of a sale key, production even center of research and development gets lost China, search likely target to undertake ceaselessly annex and buy, meaning be in a China circle of ” of this “ cake occupies market of medical devices to control limits in its inside. Go up in high-end product especially, the company that has growing symptom of a trend to China ceaselessly undertakes besieging, the formation of extruding China brand.



But from will look on the other hand, digitlization “ encircled ground ” to offer development opportunity to be the industry that support with the technology. The times is digitlized in what be forerunner with advantage technology, it is resource configuration and integrated times, the company that has capital and technical advantage can undertake resource configuration and conformity, and to only the enterprise of an advantage, according to the dimensions of oneself and advantage, will have advantage resource and butt joint of big company implementation oneself, it is the best outlet that its expand. If industry of medical devices is a few mediumer professional very strong original part produces business (OEM) it is OK to supply manufacturer to more only way develops, once had the butt joint with transnational corporation, mutual parasitism, the “ in did not make an industry very likely is invisible ” champion.



Have technologies of more own intellectual property



In intellectual economy times, who has technologies of more own intellectual property, who has stronger innovation capacity, who masters active advantageous position of competition. Market competition pattern produces essential sex to change, the strategy of struggle for existence of transnational corporation also produced a change likewise, the competitive strategy that they implement now is with intellectual property the technology is forerunner, assist with photograph of powerful capital actual strength, it is main measure with share of market of race to control from in the past, turn into to acquire the market with own intellectual property and advantage technology advocate the competition that controls right is a method. Technology of own intellectual property develops the speed of speed and technical reliability, deciding an enterprise is competitive ability of the country even, the technical standard that advantage technology place forms also demonstrates competitive ability likewise.



It is in 500 strong companies of world, its core technology may not be the toppest technology, but the own intellectual property that they own this kind of technology, or its are technical standard constitutor. These tycoons crossing a state such as general and Microsoft, IBM, electric, Xi Menzi have the technology of own intellectual property of core, and a few technologies made technology of stage of international standard, regular peace. Because these companies owned own intellectual property,the technology is mixed the standard is formed in advantage technology, had powerful technical competition capacity in market competition so, also had the active right that dominates the market at the same time. Statistical data shows, 2000, the profit total of IBM company is 8.1 billion dollar, among them the license of intellectual property, make over income to be 1.7 billion dollar, 21% what hold its profit total. Accordingly, have technology of own intellectual property, advantage, can form a standard, realize it well industrialization, can bring profit for the enterprise, innovation gives social value, be prospective enterprise base oneself upon this mixing live the ” of “ a magic weapon of get the upper hand of, it is crucial force of competition. In intellectual economy times, on prospective market the enterprise sells more will be the aeriform technology product with add old watch.

Knowledge accumulates the fountainhead that is innovation



In digitlization times, any technical innovation are to build the foundation is accumulated in early days knowledge over and undertake rise to develop with innovation, knowledge accumulates the source that already became innovation of a company. Transnational corporation can the palm accuses forward position technology, main reason is these companies have a certain number of patent technologies, the knowledge that these patent technologies are a company is accumulated, it is the intangible assets that the company forms with knowledge, it is others is taken do not go, the asset that does not take secretly. The some in these patent technologies forms occupation standard, and can use the technology that forms a standard depressing competitor. A lot of transnational corporation in industry of medical devices take his seriously very much the accumulating of relevant knowledge, wait like Xi Menzi, GE using their abundant capital to buy the company that has advantage technology in world each district ceaselessly. In other words, they already contended for product market change purely to innovate independently for contention from in the past technology and have a quantity to dominate the market with advantage technology, the purpose is the medical devices that will appear as far as possible on the world relevant innovation technology brings into a banner to fall, be in with enhancing its ceaselessly the competitive advantage position of this domain.



Technical camp upgrades gradually



The competition between prospective company, upgrade to compete for commerce of the technology of national level, economy gradually, a lot of developed countries support some intellectual property dominant positions according to its, implement intellectual property strategy ceaselessly, with intellectual property technology certain technical level regards national trade as camp, hold back other country product to enter, thereby the commanding elevation that firmly holds world science and technology and economic progress. Field of share of industry of our country medical devices is competed this kind just about by transnational corporation forestall the true portraiture of the result.



Transnational corporation is in try to make oneself intellectual property covers wider, wider range, make its make the standard of technical application hard. Because, once the core technology of an enterprise makes the standard technology of others angle when, so the advantage technology that this kind of technology also becomes this company. This kind has the technology of active advantageous position via what law affirms, can make between the enterprise direct because of the difference of intellectual property bring about enlarge of development rate difference. Microsoft is one extremely typical and rich suggestive paradigmatic: Microsoft relies on the dominant position that its intellectual property and knowledge accumulate to make its product makes standard of a kind of application, make this company had the distinct absolutely advantage that surmounts a competitor, this one advantage lets Microsoft become the dominant of whole software industry and center.



Foreign big company is in the backside that sells a product is to be in promote technology of its general character and standard, the person that market of this one product is entered after making through this kind of means must be over the foundation of people standard undertake develop and applied, the price that latter place pays will be to be mixed for a long time always unending. The medical number in industry of medical devices is video with transmission technology standard (DICOM3.0) be very good paradigmatic: DICOM standard was 1985 American Institute of Radiology and basis of Manufacturers Association of American country electron the product technology standard of a few companies and the method that image and information transmit between the equipment that makes what make in different manufacturer and agreement, the course edits for many times, already made international standard now. Each national capital must this standard design develops follow equipment of digital medical treatment, medical devices of our country number uses this one standard to undertake products plan is developed almost, exchange between different equipment with respect to very difficult implementation otherwise information and transmission image. Actually, transnational corporation uses the standard that technology of this kind of advantage forms to dominate the market namely, regard its as technical camp, hold back other country with the best will in the world to produce domestic entering, the pattern that also shows the international market competes at the same time also is in producing change, the change of custom duty camp that goes up with policy shift from in the past is the technical camp of code sex method to compete.

Standard of our country medical devices builds current situation investigation

VVH-TV News -- Lyme Disease: Medical Nightmare (Part 1)

.....Standard of our country medical devices builds current situation investigation

—— perfects technical standard system around product quality problem

Complier: In recent years. Industry of our country medical devices presents the trend that gives rapid development, people also raised taller requirement to using the security of medical devices and effectiveness. However, long-term since, the product of a few medical devices pledges capacity issue is perplexing industry of our country medical devices all the time develop. Product of medical devices is in design, development, production, use wait for link to be badly in need of strict safe level. Accordingly. Build system of perfect standard of technology of medical devices very pressing. Be based on such setting. The article is on the base that to the issuance of standard of our country medical devices the current situation has analytic study. The problem that to how be being solved active standard exists offerred constructive opinion.

As the unifinication of the rapid development of industry of medical devices and global economy, product of our country medical devices is on world stage stage by stage. Standard of medical devices shows its indispensable main effect more and more. Nearly ten years, our country begins to quicken the pace that conforms with international, cite increasingly international standard. The standard circumstance that releases nearly 5 years especially achieves the fastigium that conforms with international, the meeting year after year that the standard of international medical devices that our country place attends talks increases. Adopt the interconnected system of active standard and international standard

One, make product of our country medical devices in the world competition ability increases increasingly. Had benign stimulative effect to the development of industry of our country medical devices.

Standard of our country medical devices releases a circumstance

Since from 1984 standard of the first medical devices is released, below the joint efforts of various controller and technical personnel. Standard of our country medical devices presents development the rapid, trend that updates ceaselessly. Standard measure increases. Enclothe a face to expand, satisfied country and wholesome industry basically to be opposite currently standard demand. In the meantime, standard system is complete with each passing day. Standard measure also rises in year after year, in safety of product of safeguard medical devices ground of significant aspect utmost produced effect. End in Feburary 2008. Standard of our country active medical devices adds up to 718. Standard of its China home 162, occupation standard 556. Compulsive standard 472, recommend a level 246: Add newly standard and replace updated standard every, year have increase. Up to now, replace newer standard 623, hold overall level 86. 8 ％ , among them nearly 6 years (2002~2008) replaces a standard 188, 30 what hold newer sum total. 2 ％ : Clear rectify revocatory standard 30.

Mark age circumstance: Through standard of medical devices cleared 1999 rectify special job, level of active medical devices is at present medium, mark age is the shortest for 1 year, the longest for 24 years, mark age the standard of 4 years of less than 221, 30 what hold sum total. 78 ％ , average bid age 8. 19 years.

Cite circumstance: In the standard that issues every year before 2000. Use, cite international standard place occupies scale to wander in inferior level all the time. Later, standard of our country medical devices is being used, cite the state that standard field presents a rapid development. End by 2005, adopting equation of our country medical devices, revise use, equivalent is used, blame equivalent uses international level 275, 39 what hold overall level. 2 ％ ; After using 96 years (contain 96 years) international standard 229, 83 what hold the national level sum total that uses international level. 3 ％ , among them 2001 ～ 2005. The national level that uses international level 159, occupy use entirely, cite 57 standard. 8 ％ .

The problem that standard of go ahead of the rest exists and settle strategy

One, partial level is aged, standard system still needs to be perfected further.

To healthy attention as the public degree is increased, the rapid development of industry of medical devices, raised taller requirement to standard of our country medical devices. Show level share level existence is aged problem, cannot have satisfied the requirement of the industry. The development of industry of our country medical devices was restricted on certain level. In the meantime, standard system also is existing structure, project and technical standard edit the inadequacy that waits for a respect. Need to be perfected further.

2, the standard releases existence lag sex.

Develop in information height. Product of medical devices increasingly diversity, emphasize a function changing today, seasonable sex is gifted very principal port. Long-term since, because be mixed to standard of quality of medical devices,detect technical research lack is enough take seriously. Bring about our country to exist in advanced country of respect of monitoring of safety of quality of medical devices and abroad bigger difference. If laws of some check proved recipe are very backward, the law of check proved recipe of appliance of operation of certain medical treatment still stays in on century the level of 50 time. Because examine,the method lacks scientific sex. Factitious element is right examine the impact of the result is very big.

Be aimed at afore-mentioned problems. The author puts forward to settle strategy below to the construction of system of standard of medical devices.

One, the industry characteristic that holds medical devices. Highlight product reliability.

To medical devices. Security and effectiveness are the mainest demand. How to reach mark of this two projects? The author thinks, ensuring product reliability is important way. Product of medical devices because its characteristic, requirement must can work reliably first and last, although the addition as use time, product function is reduced somewhat, still also can make sure safety is effective. Function index the product with advanced, not high reliability is no point. This shows, dependability will become the chief quality target of product of medical devices. Supervisory management board of national provision medicines and chemical reagents was released 2000 " the risk management application to medical devices " (YY ／ T0316-2000) . Replace T0316-2003 of standard YY ／ at was being released 2003, raised the initial requirement that dependability studies to domestic medical devices. Later, the national level of current requirement and occupation standard issue functions of a series of concerned medical devices and security in succession. Taller dependability requirement raised in the respect such as electric safety and biology evaluation. Of course, from at present the case of product of our country medical devices looks, in the security that still more dependability standard needs to introduce a product is designed and be being analysed.

2, the special orgnaization that builds a technology to superintend, unite administrative program.

A when quality of medical devices revitalizes very important facet is to build system of perfect standard of technology of medical devices and administrative standard system, carry out in the round seriously carry out. Build technical skill to superintend an orgnaization, undertake unity administrative planning to standard issuance, can adjust our country well frame of present standard of medical devices, and can stand in the angle that be spent higher and develops have science government to standard of medical devices. And create relevant expert group, the organization develops system of standard of medical devices transverse (domestic and international comparison) with fore-and-aft (the development of standardization and mission) investigation and study, make the standard system that is helpful for development of industry of our country medical devices, raise its mission and target.

3, raise a level but acquired character.

Current, standard of our country medical devices is to be released on the website dispersedly. The industry is not light systematization ground is obtained, this used a standard to cause very big inconvenience to the enterprise. To can raise a level but acquired character, make the standard gets the execution of older rate, answer active standard to undertake arranging pool, release to fixed website with open form is published or be being united.

4, continue to quicken internationalization pace.

The whole world coordinates a working group to knit the tough effort through several years. Wrote the basic principle with safety of medical devices and accepted function 1999 eventually. Be record in by management of quality of ISOTC210 medical devices and committee of current requirement technology in ISOTRl6142. Current, our country still includes to be in without such basic principle corresponding medical devices is general in requirement standard. Our country should take an active part in the communication of field of standardization of international of medical devices and activity. Know the development way that the medical devices on international standardizes, more ground and international conform, make product of medical devices more safe and effective. Also create better condition to enhance the competition ability of product of our country medical devices at the same time.

Medical devices sells skill

Medical Laboratory Technician

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Medical devices sells skill

One, the first time visit.
The first pace, try every means makes the skill material of hospital of a few targets, for instance dimensions of hospital grade, hospital, year place of the division is ** that section office of function of northward hospital of …… of full name of director of business income range, use section office, native place weighs commonly, ** , if medical affairs is in; The ministry is ** that southern hospital weighs, like administrative department, purchase a ministry. 114 can use, the target section office that reachs a hospital steps on a dot also is very important.
2, visit formally.
Visit first should be use section office, to familiar hospital, can visit equipment division directly. Doorsill of use section office is low, the possibility of be rebuffed is little.
Notice at 2 o‘clock: Do not let equipment division know you have been to use section office; Product introduction wants wonderful and stop where it should stop, should introduce a product than babble with the client‘s communication many importantly.
3, actual combat dialog is analytic.
Dialog 1:
“ you are good, I am ** company, we are managed is ** , I introduce the product of our company to you now. ”
We do not need “ this kind of product. ”
“ is irrespective, I leave a data to consult for you, do you have calling card? ”
“ Is am sorry, I do not have calling card. ”
Can “ tell your connection the telephone call then? ”
If “ needs, I can phone you. ”
“ was disturbed, goodbye. ”
“ Is am sorry, make you white run. ”
Depressed. .
Dialog 2:
Director “* , hello, I am the *** of ** company, visit you presumably all the time, I had seen you be on China ophthalmology magazine * period the published article that treats about eye ground disease, write first-rately, want to consult a few problems to you all the time. ”
Do you have “ what thing? I am very busy now. ”
“ is such, director ** (his friend) call me to look for you, say this thing had you to approbate ability travel only. You are the expert that this domain has contribution quite, the treats eye ground disease instrument that I think to listen to you to be managed to our company very much has what view. ”
The data that “ takes your company comes I see ……”
Friend and skill.
Dialog 3:
Is excuse me Director ** in “ ? ”
“ is this. The …… in ” business
Director “* , hello, see you quite busy, my line puts the data on your desk, I wait for you to be free to say again outside. ” in corridor good head is free to come in again.
Director “* , I ask about economy of expensive section office is independent business accounting, I brought a kind of equipment now, suit your section office to use, and expensive section office uses this to cover instrument equipment meet inside half an year disinvestment, be gain later. Budgetary plan is here. ”
“ is really such, I see your budgetary plan. ”
The key is to solve a problem.
4, in later period works.
1. See a dean. Etc ah long for ah watch and hit out.
2. The price negotiates. The hospital once project approving, make a task of purchase department, the process is here medium, the dean won‘t participate in the price to negotiate too much commonly. It is so in sales compaign, want to treat purchase department seriously, walk along ” of course of “ high level only, company profit can get loss.

Chongqing medical devices obtains attestation of European Union CE to enter Europe smoothly

John Stossel - Medical Marijuana

Afterwards Chongqing sea is helped up " supersonic knife " gallop after the international market, "Chongqing is built " medical devices infiltrates successfully again European market. Yesterday, limited company of equipment of medical treatment of Chongqing day sea signs 16 million euro formally with Italian EUROLABOR company (about 160 million RMB) exit agreement, medical devices will export mark day sea formally European market.

..Lu Anzhou of day sea president discloses, medical devices enters day sea already middle east, southeast Asia and United States. This year March, day sea obtains attestation of CE of European Union product successfully again, carry license of admittance of European Union market. It is reported, this is manufacturer of our city medical devices the 2nd piece when obtain enters those who enter European Union market " passport " , june 2005, chongqing sea helps supersonic knife up to make the product of medical devices that home beats European Union market first times.

..Lu Anzhou expresses, day sea already opened up endowment 200 million multivariate, the ground is encircled in garden of industry of south bank the Yangtse River 142 mus, plan to make garden of industry of day sea medical treatment, predict to built go into operation 2009. Will introduce company of British and other places to undertake cooperative, form medical devices to make, illume of medical treatment of haemal fluoroscopy, semiconductor 3 big industries, production value of the year after next of predicting put into production will be achieved 1 billion the left and right sides.

Relevant news:

Business of about a hundred change is brisk in this industry, guo Yi of Lu Anzhou of sea of Hua Lun Wu Jilun, day, west hill army, golden hill of golden hill king already had international competition ability

Previously, our country should cost several dollars every year to import equipment of many medical treatment from abroad, home has the market of medical devices of 70%% to be divided up by the developed country about, but this one state is changing now, only a few of Chongqing large medical devices produce business, had developed a tight encirclement, export the product to the market such as Euramerican, southeast Asia.

The industry of medical devices of Chongqing starts later, but development is swift and violent. From on 70 time go to the century 90 time, industry of Chongqing medical devices from do not have have, preliminary formed an industry branch. According to statistic of guild of Chongqing medical devices, up to last year the end of the year, our city medical devices produces an enterprise to had had more than 160, formed the industry of medical devices on real significance and industry of new-style number medical treatment.

Current, active there already are about a hundred in the change business of industry of medical devices, have many having among them own intellectual property, have international competition ability. The golden hill of king of boss of golden hill science and technology that develops an intelligent capsule for instance, development movable type store can the Wu Jilun of Hua Lun medical treatment of X smooth machine, sell blood to examine the Lu Anzhou of day sea medical treatment of equipment get rich, west hill science and technology that establishs occupation standard of operation power plant.

Hua Lun Wu Jilun: Do poineering work the earliest innovation turns over

Wu Jilun, male, 72 years old, president of limited company of medical devices of Chongqing Hua Lun.

Wu Jilun is the person that industry of Chongqing medical devices does poineering work one batch the earliest. He is graduate of undergraduate course of major of the first batch of medical devices of our country, ceng Ren Chongqing is medical director of institute of medical devices of chief engineer of company of industry of medical devices of facility plant factory manager, Chongqing, Chongqing, go into business of the ability after retiring does poineering work, bear a suit external debt at first, but he holds to own innovation by right of persistence and perseverance, final development goes much gram to be heated up oneself phlogistic painful stick with one action to turn over, year sale many yuan 3000, and the CE highest attestation that took European medical devices, sell as far as to and other places of southeast Asia, Euramerican, Australia.

This year, wu Jilun develops a success again high frequency and medical machine of diagnostic X ray, realize movable type first store can Chongqing of X smooth machine is built, fill of this one new product home is blank, new product of key of the our city that be labelled. Current, hua Lun is about to build in 100 mus of of big crossing entire new product line, predict to produce per year a quantity to be able to amount to 1500.

Day sea Lu Anzhou: Circle ground does tea garden greatly strong

Lu Anzhou, 44 years old, general manager of limited company of equipment of medical treatment of Chongqing day sea.

In March 1995, raise fund in the Lu Anzhou of college teach school and friend 36 thousand yuan established institute of equipment of medical treatment of Chongqing day sea, official go into business.

The first kind of product that Lu Anzhou develops is one kind full automatic blood examines equipment, domestic manufacturer home is very few, major hospital uses entrance device. The base of gain of science and technology that studies in recumbent college, this kind of equipment that Lu Anzhou produces opens the market very quickly, only northeastern region earned 800 thousand yuan.

After 11 years, day sea medical treatment already ranked domestic blood to examine before equipment market industry 3, the product exports and other places of Egypt, Indonesian, Vietnam, United States. This year, the Lu Anzhou that does bigger more encircles the ground in south bank tea garden again 148 mus, university of preparation and British Deng Di cooperates, build western center of illume of semiconductor of the first Sino-British international, and " semiconductor lighting engineering is in of medical devices apply " this one new project, also applying for to enter 863 plans.

West hill Guo Yi army: Read go into business specializes in cure instrument

Guo Yi army, male, 41 years old, president of limited company of science and technology of Chongqing west hill.

18 years old read from native place Zhejiang, the reason that Guo Yi army left to indissoluble with Chongqing knot from now on. Arrive from undergraduate course, graduate student doctor, do poineering work to oneself again to market selling manager from the teacher when the boss, career mixes the student of Guo Yi army to be in from business experience around medical devices this industry revolve.

In May 2000, guo Yi army establishs west hill science and technology, main attack project is operation power plant, a skull getting that for instance the operation uses, electric drill. At that time, this one product relies on an entrance mostly, a machine should spend 400 thousand yuan at least - 500 thousand yuan, very costly.

Last a period of time 6 years, guo Yi army leads group research and development to give plant of power of first DK operation not only, the product sold the whole nation many 200 hospital, the price imports the 1/3 of the product only, and still get the country feeds medical inspect bureau (SFDA) accredit, establish the national occupation standard of category of product of this one medical devices, next year of this standard hopeful comes on stage.

Everybody talks fortune hero honored guest: Guo Yi of president of limited company of science and technology of Chongqing west hill army

Topic one: You most who is admired businessman?

Zhang Ruimin of presiding apparitor of sea Er group and associate group author Liu Chuanzhi.

These two people have very strong professional distinguishing feature, zhang Ruimin accomplishs Haierji from assistant manager of company of a home appliance round presiding apparitor, liu Chuanzhi does poineering work from transition of researcher of Chinese Academy of Sciences make piece associate Caesarean, their professional setting makes the rational thought of two people very strong, play sober, have global strategic eye, and they the heart is not had by look for, of one mind is dedicated at advocate course of study, this ability accomplished two entrepreneur and the fortune legend of two old homebred brands.

Topic 2: You most who is the change business of appreciation?

Yin Mingshan of boss of force sail group and Zun Zongshen of boss of Zong Shen group.

This two people are Chongqing rub help old man. Zun Zongshen although culture level is not high, but courage and insight is outstanding, very individualize, when industry development still is in muddled condition, dare enter dare go all out, make a the world. Yin Mingshan also has eye very much, be good at capturing business chance development to expand, his character charm is in Chongqing rub in the side very distinctive, he is built successfully still this year gave force sail car, laudable.

China International medical devices (Shandong) exposition

Ali G - Medical Ethics

By the whole nation government of people of city of association of wholesome property business management, Jinan, Shandong saves cure society and China International commerce to promote committee Shandong to save branch to be sponsorred jointly 2010 medical devices of the 24th China International (Shandong) exposition (autumn) and, beijing numerous benefit and the medical instrument that health science and technology develops limited company to carry a series of company international to precede attend this second exhibit meeting, the French eagle of my company between meeting exhibition period performs system of scanning of health of DDFAO whole body, korea glad points to analyzer of rich spirit pressure, holand AGEs candy base change eventually the product such as child detector is paid close attention to extensively, hospital of Shandong university Qi Lu, shandong provincial hospital each expert of large hospital and agency of medical devices are exhibited to my company look around, negotiate cooperative matters concerned.

The solution that RFID uses wholesale managing at medical devices

Rep. Ron Paul meets a medical marijuana patient--Nov. 9 2007

Work to improve the maintenance of medical devices, reduce missing state, wet benevolence company of medical treatment system is putting active RFID tag in succession in wheelchair, aerobic bottle and other on the medical devices that wants hire to give a customer.

On July 25, 2006, the medical jobber of ministry of Chinese and Western of an United States wets benevolence company of medical treatment system RFID label stickup on the medical devices that give to a lot of hire or sells a customer, through using RFID label, company and client are OK better dog the product of inventory is safeguarded regularly with what assure a product.

This company uses the active label of 915MHz in injector, appearance of portable nuclear magnetic resonance, wheelchair, aerobic bottle, decrease automatically quiver implement, go up with other medical devices. Every label has an UID identification code, with wet benevolence the electron that company of medical treatment system offers tracks software WrenTrack to undertake form a complete set is used, renTrack records the lifecycle of below each product, such families nurse the supplier of the product and user can track these products to be sent what place, at the same time OK also monitoring clean and defend the work of these products. Now, the application of RFID label is a form to piled up a system to increase additional protection, ensured medical treatment instrument can be produced according to the regulation, clean, safeguard and store.

Current, wet benevolence the user of the company is applied hold infra-red read write implement a form code label that scanning deposits the medical devices in checkpoint to go up. For example, begin an examination to be about to send toward a in patient home to be decreased automatically when a worker quiver implement when, he is used read write implement come to this scan decrease automatically quiver implement a form code that go up, read write implement feedback gives a form code information that scans the computer all round, show the result of a series of problems through WrenTrack software come. These problems include the worker‘s name, why will check this medical devices, this medical devices will carry where. If equipment is about to undertake expectant maintenance checking, employee also can be in be informed for a short while. After adding RFID label, supervisory job becomes very simple: If an employee forgets a form code on equipment of scanning medical treatment, or the information in software already by cram, when the instrument by move when, an installation is read in the RFID of checkpoint write implement can read the RFID label that takes medical treatment instrument to go up, call the police to WrenTrack system, and have on all computers that run this software show.

Wet benevolence company of medical treatment system has all give renting the droit of the medical devices of the user. So the company hopes to undertake supervisory to store and be being safeguarded of those medical devices. WrenTrack software is a software that is based on a network, can make wet benevolence company of medical treatment system dogs easily all medical devices that come from headquarters.
So far, wet benevolence company of medical treatment system is in about 50, 000 different medical devices used a form code on material, and plan be in 8 the middle of a month that did not come 100, material of 000 many medical devices deploys a form code. Ward of • of Er of company chairman Michael says, wet to at that time benevolence company of medical treatment system will be in about 25, RFID label is used on material of 000 medical devices.

WrenTrack software system needs a RFID to read write implement, this is read write implement can read inside limits of 100 meters of radius take label. Ward says: To most user, one is read write implement can offer read enoughly take range. Each are read write implement the network server join that contains IP address with, wet so benevolence company of medical treatment system can dog through the position of the user RFID is read write implement the position. Ward is offerred for the user be installed in the round and debug. WrenTrack system, form code scanner and RFID hardware can choose to be offerred by Wrenmedical, the user needs to pay only can. Wet benevolence company of medical treatment system is in charge of debugging software, install equipment, according to the user the requirement undertakes constructional. So far, wet benevolence company of medical treatment system has run WrenTrack system in about 200 places, ward says the company already installed RFID system then in a few users, but reject to make detailed introduction.

Wet benevolence company of medical treatment system believed to apply RFID technology to be able to think the company also is an user to improve asset management, ward says " since had RFID, if any medical treatment equipment without scanning left some site, we are met know for a short while. " the explanation says Ward: Will form code and RFID label are used at the same time, we just know, what is true inventory management.

As the use of RFID label, the amount of inventory is more exact, the client‘s expense also decreases subsequently. User hire or bought medical treatment equipment are average and annual, every need is cost 2, 000 dollars. And the loss of the user obtains these fee 10% to 15. Additional, because nurse company cannot seasonable from the patient over there resumptive medical devices, they must need much hire more actually than its or buy 30% to the equipment of 35% .

The harmful response of medical devices is invisible glasses resides head of a list of names posted up

Medical Massage For Hypertension

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Reporter yesterday learns from bureau of city medicine inspect, in the harmful response of near future medical devices invisible glasses resides head of a list of names posted up. The expert expresses, invisible glasses belongs to medical devices, sale glasses inn should look to whether have management aptitude when buying.
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According to statistic of bureau of city medicine inspect, end October, receive medical devices in all undesirable incident reports 70, involve soft cornea to contact lens among them (namely invisible glasses) have 15, rank head of a list of names posted up.
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Wuhan loves Er ophthalmic hospital to inspect Xie Guisheng of smooth department head to remind, buy invisible glasses needs to ask professional oculist guidance, close check should have before check matchs, include computer optometry, check shadow optometry to wait, the first time the person that adorn undertakes checking in a week after adorning and a month. The eye cannot be rubbed with the hand after wearing, cannot bathe, one day adorns time cannot exceed 8 hours. (data sources: LOOK glasses net
Http://www.lookwoo.com)

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Industry of medical devices invested an analysis 2010 -- benefit cure changes add crash long

Michigan Medical Marijuana Organizations

One. Definition of medical devices:
Point to perhaps combine alone use the instrument at human body, equipment, implemental, data other perhaps goods, include the software of a need;
The function that its use within watch of human body body and body is not to use the method that pharmacological, immunology perhaps metabolizes to obtain, but the likelihood has these hands
Duan Can and the auxiliary function with rise particular.
2. Global industry 9 years of market condition
Since entering new century, global medical devices exports market dimensions to magnify continuously, although be below the circumstance that financial danger four sweeps past, 2009 1-11
The month also reached one hundred and seventy billion four hundred and eighty-seven million dollar. As we have learned, 2007, size of market of global medical devices amounts to turnover of 300 billion dollar, commerce
It is 170 billion dollar about for trading business volume of 340 billion dollar, import about, average increase rate is the market 7% , market vacuum is giant.
Suffer economic crisis effect, demand of European Union import glided 2009 4 percent, its basically import origin country to be the United States, Switzerland,
The country such as China, Japan, among them China holds market share 8.35% , grow 2.1% compared to the same period. The others country glides somewhat.
Regard the whole world as market of the 2nd big entrance, american demand glided 5 percent, reached twenty-seven billion one hundred and eighty-five million dollar only 2009. As a result of this
Country the market is splitter, fail to form one state alone great topological features, the country such as Mexico, Ireland, Germany, China, Japan is being held main
The market, take import market 60% . China is the United States trade of the 4th big entrance is companionate, own the market share of 9% , came from China to enter 2009
The mouth grows 5% .
2009, japan imports demand to keep balance basically, glided 0.59% , the United States held main market, portion is as high as 36% . China
It is associate of the 3rd large trade, came from Chinese entrance to grow 7.26% , market share is amounted to 9% .
Data makes clear, europe, beautiful, day is the whole world markets of 3 big medical devices. Chinese market share is occupied 7% , year all increase rate is amounted to 18% ,
Have powerful inside need the market and the export market that grow quickly, become the state that has growing latent capacity most. Medical devices is relevant 2009 enterprise
Already amounted to 22666, exit forehead already amounted to 12.24 billion dollar. Chinese medicine health care tastes vice director of chamber of commerce of imports and exports ministry Cao steel expresses, in future,
The correlation of industry of our country medical devices and international market is spent will taller and taller.
Statistic shows, 2005, china already made the world that is next to the United States and Japan market of the 3rd big medical devices. 2006, in
Country frontal head exceeds imports and exports of medical devices one billion four hundred and ten million and sixty-five thousand four hundred and eight dollars close greatly, grow 17.57% compared to the same period,
The forehead 3.19 billion dollar. Amount of imports and exports of Chinese medical devices was twelve billion six hundred and ninety-seven million dollar 2007, grow 20.33% compared to the same period, annual commerce is suitable
Need 4.133 billion dollar.
In January 2010, our country medical devices exports amount to amount to nine hundred and fifty-four million eight hundred and nine thousand dollar, grow 10.73% compared to the same period, achieve the history new tall.
3. Pattern of home market competition
Industry of our country medical devices by small arrive big, develop quickly, already became category of a product to compare ability of all ready, innovation to increase ceaselessly now,
The sunny industry with market very exuberant demand. Especially in recent years, industry of medical devices grows speed to be accelerated further, not only produce per year more continuously
The value maintains two digit growth, and the quantity that the product exports and content of science and technology also promote ceaselessly.
Accelerate move as international industry, china will become the significant production base of global medical devices, the instrument that counts an import formerly partly is set
Coming true stage by stage fully homebred replace an entrance. The expert points out, henceforth 10 to 15 years, industry of our country medical devices will enter high speed to develop level.
According to concerning a section newest data shows, 2009, bead trigonometry, long triangle and group of industry of bay of annulus Bohai Sea lead an industry development, guangdong, Jiangsu,
The province city such as Shanghai, Zhejiang, Fujian, Beijing, Shandong, Liaoning, Hubei and Tianjin before the row 10 exit, among them forehead of Guangdong province exit is amounted to 28.82,
Occupy than 23.54% , be among the best of candidates.
Meanwhile, also want to see equipment of medical treatment of domestic high end basically has been held by the product firmly of transnational corporation, our country medical devices is produced
Industry grows instability, medical devices is superintended start later, business of medical devices is small, much, come loose to still did not get with the phenomenon of low-level competition
Essential sex transforms, the technical innovation capacity that increases property of our country medical devices quickly, yield that strengthens medical appliance research and development, learn, grind jointly, had become urgent matter. Market of Chinese medical treatment has 70% to master in hand of international big plant about, GEHealthcare, Siemens, Philips
Already set a plant in home, market of medical treatment of China of active race to control.
Main and video diagnose kind of product annual in light of sale, besides abroad big plant is main supplier outside, also see of all kinds product all have
Chinese home manufacturer is participated in.
Computer fault scanner is current the whole world is only 4 countries, 7 companies have the capacity of own production, and China east soft represent for China namely
company. Scanner of fault of Chinese market computer with 16 cut with 64 cut give priority to abortion to taste, among them 16 cut markets master in Philips and
In Toshiba hand, and 64 cut the market to be lead firm by GE Healthcare, china east soft in market of scanner of integral computer fault
The sale is next to GE Healthcare, for aggrandizement its compete advantage, 2004 east soft with Philips coact, those who use technical communication
Means, let the technical gap with complemental and former both sides, east soft the way that adopts strategy of open mode innovation, make its are offerred by former and single medical treatment facility
Money business, the digitlization hospital that change serves for medical treatment system and medical treatment IT is comprehensive the offer person of the solution.
Magnetism resonance product develops ceaselessly as global technology, also drove the development of product of resonance of Chinese home magnetism, 2004, in statistical discovery
Home already had the state more than 200 hospitals have this kind of product, nevertheless, in light of the contented degree with equipment of advanced country medical treatment, average every
1 million people have product of 40 magnetism resonance, and at present every 1 million people are less than China 2, showed China still has very big demand not by full
Sufficient. Chinese tall field and market of resonance of freeboard field magnetism are at present main by cross institute of national big plant to control, and after low field adopts entrance package mostly, assemble, and
Character and into poorer like speed, add price on the high side, lack competitive advantage. At present Chinese home has Beijing of Gao Yihe of Xin of new Ao Bo, Ningbo 10 thousand
The manufacturer waits to produce magnetism resonance product east, technical character still has ascensive space.
Already approached the rate that international manufacturer place produces what video equipment produces ultrasonic at present gradually, because ultrasonic is video,basically be the technology is diagnosing a shadow
In resembling a product, opposite technology doorsill is inferior, chinese home manufacturer serves as with this product cut hi-tech the first pace of video equipment, manufacturer collect
The technology of this product is developing in, make ultrasonic at present video technical development is more perfect already. In addition, because of,Chinese place manufacturer can understand more
Cure changes the giant business chance that policy brings, and know very well sensitive to the price China market, par changes the key of the size that is main effect market
Element, because this home firm is main,give priority to with black and white ultrasonic with producing B to exceed. Basis China statistic reports the data shows, 2008 China
Churchyard has many 30 firm about, among them the mainest install head of division hi-tech Inc. , Shan for Shenzhen respectively supersonic instrument institute and
Limited company of Shanghai Mai Disen medical devices. Among them Shenzhen installs division hi-tech Inc. to be 1986 by the Chinese Academy of Sciences and
Analogic is collective and joint-stock the company of high-tech medical devices that establish, have opposite international big plant besides its relatively outside the equipment of par, also accumulate at the same time
Extremely seek level of as congener as international product, manufacturing color is predicted strap ultrasonic and scanner of black and white and supersonic wave, with because answer,differring the demand of the market.
Digital X is smooth of detector of product criterion basis different can divide reach for veneer double board digital X optical system, light of veneer number X basically is used at limb and thorax
Examination, and double board digital X optical system can finish the whole body the examination of each place. At present digital X light basically is supplied by international manufacturer place, with
Siemens, Philips, Carestream Health, GE Healthcare and ShimadzuCorporation are given priority to want 5 big supplier.
4. Cure changes the effect that develops to the industry, domestic industry grows new trend
The industry that 1. cure changes is affected
2009, china promotes medical treatment reform formally, announced " the opinion that the State Council of Central Committee of Communist Party of China reforms about deepening medical sanitation system " ,
Will 2009 - enlarged medical treatment budget 2011, increase 8, 50 billion, main goal is being protected at realizing doctor of the whole people, establish medical service of perfect basic level
Cure serves a system, solve people to see a doctor expensive the question with see a doctor difficult, also promote basic and public wholesome service to be changed equably at the same time, build a nation basic medicine
Content system and advance public hospital reform is pilot. Among them, system of rural medical treatment is the target object that reforms this, because,basically be
North and the hospital of inland villages and towns of the area lack a standard to configure or repeat configuration the phenomenon is serious, accordingly period make can solution of policy of reform of medical treatment of by means of
Definitely the plant layout of hospital of 39441 villages and towns presents disequilibrium state, also show those who say to accord with GB to purchase limits is medium cheap base
Equipment of plinth medical treatment is the development opportunity with the greatest reform of this medical treatment namely, resembling is portable or portable diagnosis is video equipment.
The new medical treatment that released last year according to China reforms scheme, inside 3 years since last year, in the center of to medical treatment sanitation with local government the industry invests
200 billion yuan. According to lucky silver the group invests sectional estimation, in allowance of courtyard of its doctor of traditional Chinese medicine 1/3 will use at China the hospital of 20 thousand above and 30
Hospital of 10 thousand countries buys new medical treatment facility newlier.
The expert points out, this is lesser to many 3000 dimensions and the company of production of domestic medical devices with market limited ascendant, be fond of care half. Happy is market of high end of Chinese medical devices is held by foreign enterprise all the time, domestic company can be in only low end the market relies on price war competition. As new
Cure changes plan to advance, basically be aimed at basic level is market of rural medical treatment even, will give undoubtedly have price advantage and the state that has mature channel and network
The enterprise offerred entered opportunity inside.
By what guild of medical devices sponsors Guangzhou city Guangzhou medical devices exhibited news 2010 the bulletin discloses trade of our country medical devices on the meeting
Total 2010 production value will achieve 100 billion yuan. In the near future, industry of equipment of Chinese medical treatment grows 20% every year, be in among them in low end medical devices
The increase rate of the respect more amount to 30% .
New structure of 2. home competition -- market of endowment of inside and outside gradually hasten coincide, competition is directer and intense
Because cure changes to tilt to basic level, the market space that the huge gap of hospital equipment produces even temporarily " adv unimaginably " . Money of compasses of Ministry of Public Health manages
Data shows, at present equipment of more than 2000 county hospital of our country configures average breach 30% , specific for, this includes medical service of many 2000 county of countrywide
Hospital of villages and towns of many 5000 courtyard, center and service center of 2400 community sanitation reach 30 thousand ～ the construction of clinic of 50 thousand villages.
Say to international old brand, rely on brand and product only can the period that firmly palm dominates the market already far go, want to live firmly in Chinese market
Calcaneal, need is done morely, for instance, more than roll out new product, should cooperate actively with agency more, roll out sale of more a complete set of to solve
Plan, and put down figure, in be aimed at low end the market develops more " economy is applicable " machine and the solution of fundamental medical treatment that are aimed at Chinese market technically
Definitely plan.
Serve as the world‘s greatest medical treatment to become for example resemble and IT supplier, acute medical treatment aing jade-like stone is in while to traditional high end the market rolls out a product, apparent
Considered in products plan more " Chinese national condition " . Compare with the product photograph that fixes a price to fluctuate in 2 million yuan before for example, acute medical treatment aing jade-like stone grinds newly
Send resembling systematic price is former only 1/3 even half, and 6 seconds are become picture, wait for a characteristic to locate directly movably at rural market
In low end hospital. In low end the proportion that product sale holds total sales promotes in year after year, 2009, specific gravity had been achieved 40% .
Regard domestic base as the bibcock of medical devices, fish dive medical treatment is benefited to what cure changes experience most direct. Money newspaper showed 2009, fish dive
Medical treatment did business 2009 income and profit total are 537 million yuan mix 118 million yuan respectively, relatively grew respectively 2008 34.03% with 61.16% .
Dong Bi Chen Jian expresses to the reporter, although brand of foreign capital high end is down osmotic effect to still need for some time to just can be shown, but be in now 2 class cure
Courtyard even a few common 3 class hospital, the competition of mainland and company of foreign capital appliance has begun to show, "Each other are in of little nibble the other side
The market, who to see a bit faster. " he says.
Fish dive medical treatment began to build independent professional laboratory 2010, chen Jian calm old, the development previously compares extensive, must go now
Specializationed road, he discloses, fish dive medical treatment hopes to be in certain the domain that be good at, make the oxygen machine occupation standard that establishs China for instance, final
Still want to rely on content of science and technology to compete.
With fish dive medical treatment, soft cure is in east after new 2009 medical service changes policy to announce before long, released quickly " medical sanitation is solved in the round square
Case " , increased the direct cooperation with hospital terminal. East soft group vice president, east root of river of president of soft medical treatment discloses, east soft at present already
Fill the collaboration of more than 30 hospitals such as Beijing hospital to form medical treatment group with Chinese medical university, make differ with technical measure of layer class hospital examine result
Can each other admits, support cure to change advocacy large hospital and community hospital thereby between turn examine, lead preoccupy terminal market.
The aspiration that another bibcock Shenzhen of domestic strides lucky internationalization is more direct. Xu Jiajun of chief inspector of the home market that stride luck says: "Still do not have in international tycoon
Have when making basic level market, we are in this market, now, we want morely outward, to more high-end market is stood by. " stride luck
Taste by initial brief per unit area yield -- build up of appearance of custody of hematic oxygen degree of saturation, develop B of word of current haemal analyzer, total number to exceed, full automatic biochemistry
The equipment of series medical treatment such as analyzer, it is forerunner with the technology, the international business of resource is disposed in the whole world.

~~ Medical Protection appliance / ~~ of common sense of advertisement of health food of medical devices of medicines and chemical reagents

Dina Martina - Medical College Commercial

1, before is advertisement of medicines and chemical reagents, medical devices, health food released, need to examine and approve?
..Concern the provision of legal laws and regulations according to our country, advertisement of medicines and chemical reagents, medical devices, health food must supervise management department to examine via provincial food medicines and chemical reagents before release. After examining approval, send advertisement to approve article order. When advertisement is being released, must indicate the signal of advertisement approval article that nucleus of supervisory management department of food medicines and chemical reagents sends.
..Did not obtain advertisement to approve advertisement of the medicines and chemical reagents of article date, medical devices, health food to must not be released.
..2, how to identify medicines and chemical reagents, medical devices and health food advertisement to approve article date and period of efficacy?
..Advertisement of medicines and chemical reagents, medical devices, health food approves article order form to be: Advertisement examines the abbreviation of the province of mechanism seat, municipality, municipality directly under the Central Government, add advertisement category and 10 digit word. Before 6 delegates of 10 digit word examine a particular year of approval and month, 4 delegates examine the advertisement serial number of approval after, be like: Beijing medicine wide careful (civil) wide careful of instrument of cure of the 2005010001st date, Beijing (civil) the 2005010001st date, Beijing is fed be good at wide careful (civil) the 2005060180th etc.
..The period of efficacy of date of article of approval of advertisement of medicines and chemical reagents, medical devices, health food is a year, can give advertisement to release from the judgement in approving article order whether be inside period of efficacy.
..3, at present, what does advertisement of illegal medicines and chemical reagents, medical devices, health food have to basically behave a form?
..Release advertisement without examining and approve do sth without authorization (be like: Release advertisement of the drug that approves article order without advertisement, medical devices, health food) ;
..Do sth without authorization distorts the advertisement content that examines approval undertakes issuance (whether did the ad that judgement has advertisement to approve article order distort to examine content, but basis " how to spot ad of illegal medicines and chemical reagents, medical devices, health food " try to judge, also can land Www.sfda.gov.cn to undertake inquiring) ;
..Forge, risk use or use expire date of article of invalidation advertisement approval undertakes issuance (land Www.sfda.gov.cn to examine and approve article date to undertake inquiring checking to advertisement, OK also basis " how to identify medicines and chemical reagents, medical devices and health food advertisement to approve article date and period of efficacy " undertake judging) ;
..Prohibit releasing advertising medicines and chemical reagents to release advertisement (be like: Anaesthetic medicines and chemical reagents, spirit medicines and chemical reagents, noxiousness medicines and chemical reagents and radioactivity medicines and chemical reagents) ;
..4, how to spot ad of illegal medicines and chemical reagents, medical devices, health food?
..The ad that whether there is classics food medicines and chemical reagents to supervise management department nucleus to send in should examining advertisement above all approves article order. Advertisement of lawful medicines and chemical reagents, medical devices, health food should send markers to give advertisement to examine approval article number in print.
..The following content should not contain in the advertisement via examining approval:
..The language that changes absolutely is contained in advertisement, be like: Effect a radical cure, eradicative, do not rebound, medicine is divided to disease, the diction such as the national level, most advanced science, highest technology.
..Contain in advertisement " invalid refund " , " insurance company is safe " , " avirulent side-effect " , " take 1 to disease of a few period of treatment devoid " wait for acceptance.
..The effect that benefit contains to be a product with orgnaization of unit of medical scientific research, learning, medical establishment or doctor in advertisement makes proof and affirmation, perhaps claim this product be waited to recommend the content such as the exclusive or optimal product that is health care of remedial disease, rehabilitation by some learning orgnaization, government sector, medical establishment or doctor.
..Contain in advertisement cure rate, businesslike and the content such as bear the palm.
..There is the letter of patient incoming letter, acknowledgment effect that is a product to make a proof in advertisement, after claiming to use this product, disease is reduced or the content such as heal.
..In health food advertisement, claim to be able to treat some kind of disease, can treat the content such as diabetic, tumour for example. ..Information form code: 728382754152867

925 programs are making industry of medical devices encourage " walk out of "

Second year medical school

Chinese cure protects Cai Tianzhi of head of department of medical devices of chamber of commerce to introduced to the reporter recently, situation of development of production estate of our country medical devices is favorable, of this industry " 925 " plan intense in making.
Meanwhile, cai Tianzhi expresses, the exit of industry of medical devices of second half of the year adds fast hopeful to continue the swift and violent impetus first half of the year, annual is added fast will achieve 18%-20% .
Urge a company " walk out of "
According to divulging, industry of medical devices " 925 " in the program, will urge a company " go " , encourage an enterprise to increase the cooperation with foreign capital.
Come from Dongguan to appear on the market the personage tells Shanghai negotiable securities the newspaper related iatrical of company in relief general, the consumption of medical devices of American market occupies whole medicine to consume the 40%-50% of amount, the vacuum is giant. This personage expresses, collect blood-vessel to be with vacuum exemple, consumption of average per capita just is less than our country 1, and consumption of average per capita is 4, the United States is 10, accordingly, development is abroad the strategy, hold to " go " will make the development policy with Yang Pu adamantine medical treatment.
And in " go " in the process, fish dive iatrical basically exports a product to already all obtained the Japan, European Union attestation that imports an area, because relevant attestation job is time-consuming longer, cost is higher, the advantage of product international attestation will make a competitor be in short-term inside surmount hard.
It is reported, enterprise of our country medical treatment develops American market to already had successful precedent. Facility of the China that entered American market all right together through buying the United States 2008‘s largest high-tech medical treatment creates a company -- limited company of medical treatment of the international that stride luck, up to now the product that the company develops production independently already had nearly 40% to infiltrate international market.
Export increases hopeful to quicken
The export growth hopeful this year quickens our country medical devices. "Since since global banking crisis erupted 2008, euramerican wait for a country to be in of medical devices purchase fund somewhat shrink, they are being searched more cheap replace a product. And product of our country medical devices is a weapon with cheap of qualitative actor price, on the base that increases ceaselessly in level of workmanship, research and development, export situation when the river rises the boat goes up-particular things improve with the improvement of the general situation, prospective 2-3 year foreground also comparatives value. " the exit prospect that Cai Tianzhi evaluates industry of medical devices so.
Keep the data that chamber of commerce published recently according to cure, 2010 first half of the year, asia, Europe and North America remain our country medical devices to basically export the market, corresponding exit forehead is 2.164 billion dollar, 1.838 billion dollar is mixed respectively 1.878 billion dollar, 3 person be occupied compare coincide plan to be as high as 89.45% .

Article origin: Clever medical industry

Medical devices manages business license to run way

Swine flu vaccince may have medical threat?

Medical devices manages business license to run way

(bureau make the 15th)

.

." license of management business of medical devices runs way " supervised joint hearing of Wu of management board bureau to discuss via national provision medicines and chemical reagents on June 25, 2004 through, grant to announce now, apply since the day that announce.


Two years on August 9

General principles of the first chapter

The first controls government to strengthen what manage a license to medical devices, basis " medical devices monitors regulation " , make this way.

The 2nd " license of management business of medical devices " hair card, change card, change to reach supervisory management applicable this method.

The 3rd manages the 2nd kind, the 3rd kind of medical devices ought to hold " license of management business of medical devices " , but the 2nd kind of a few medical devices that can assure its security, effectiveness through convention management in current process need not apply for " license of management business of medical devices " . Do not need application " license of management business of medical devices " directory of product of the 2nd kind of medical devices supervises management board to make by national provision medicines and chemical reagents.

Supervisory management board of medicines and chemical reagents of provision of the 4th state is in charge of the whole nation " license of management business of medical devices " supervisory government works.

Province, municipality, municipality directly under the Central Government (food) supervisory management department of medicines and chemical reagents is responsible inside this area under administration " license of management business of medical devices " hair card, change card, change and supervisory management job.

The city stage that sets an area (food) supervisory administration of medicines and chemical reagents perhaps is saved, municipality, municipality directly under the Central Government (food) the prefectural stage that supervisory management department of medicines and chemical reagents sets directly (food) supervisory administration of medicines and chemical reagents is responsible inside this area under administration " license of management business of medical devices " day-to-day supervisory management works.

Supervisory management board of medicines and chemical reagents of provision of the 5th state carries out medical devices to manage quality standard to run a system stage by stage. Medical devices manages quality management standard to supervise management board organization to make by national provision medicines and chemical reagents.

The 2nd chapter applies for " license of management business of medical devices " condition

The 6th application " license of management business of medical devices " ought to have following requirement at the same time:

(one) have the quality administration that suits with operation and photograph of scope of operations or full-time quality administrator. The relevant and professional record of formal schooling that quality administrator ought to have a country to approbate or title;

(2) the management place that has the opposite independence that suits with operation and photograph of scope of operations;

(3) have what suit with operation and photograph of scope of operations to store condition, include to have those who accord with requirement of item characteristics of medical devices to store establishment, equipment;

(4) ought to build perfect product quality to run a system, include to purchase, replenish onr‘s stock is checked and accept, system of check of custodial, delivery of cargo from storage, quality trace mixes storage the report system of undesirable incident;

(5) the technology that ought to have the photograph of product of medical devices that runs with its to suit grooms and the ability of after service, perhaps agree provide technical support by tripartite.

The 7th application " medical devices manages business license " , must pass (food) the examination of supervisory management department of medicines and chemical reagents is checked and accept.

Province, municipality, municipality directly under the Central Government (food) medicines and chemical reagents supervises management department ought to according to this method, join this area under administration actual, make medical devices manage enterprise examination to check and accept a standard,

The 8th " medical devices manages business license " the administrative category that stated scope of operations ought to classify the regulation in catalog according to medical devices, kind code name name is affirmatory.

The 3rd chapter applies for " license of management business of medical devices " program

The 9th plans to do enterprise seat province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents is in charge of accepting " license of management business of medical devices " the application that send card.

The 10th province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents ought to be in website of its executive authority perhaps applies for to accept a place make public show application " medical devices manages business license " requires condition, program, .

Eleventh application " medical devices manages business license " when, ought to submit following data:

(one) " application form of license of management business of medical devices " ;

(2) department of industrial and commercial administration issued company name beforehand approve proves a file;

(3) the Id that plans to do company quality administrator, record of formal schooling or title proof photocopy and resume;

(4) plan to handle company origanization construction and function;

(5) the situation plan that plans to do an enterprise to register address, storehouse address, ichnography (make clear an area) , building property right proves (perhaps rent an agreement) Xerox;

(6) plan to do company product quality to manage system file to reach store list of establishment, equipment;

(7) plan to do company scope of operations.

Dozenth an applicant ought to to plan to do enterprise seat province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents puts forward " license of management business of medical devices " the application that send card.

Put forward to the applicant " medical devices manages business license " the application that send card, province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents ought to make processing respectively according to following case:

(one) application item does not belong to this sectional limits of one‘s functions and powers, ought to make the decision that does not grant to accept immediately, send " do not grant to accept advice note " , inform an applicant to apply for to concerned branch;

(2) of the mistake that application material existence can correct on the spot, ought to allow an applicant to correct on the spot;

(3) application material is not all ready perhaps do not accord with legal form, perhaps ought to be in on the spot 5 workaday indrawn applicants are given out " make good omissions material advice note " , one-time the entire content that informs need to make good omissions. Exceed the time limit does not inform, it is namely since the day that gets application material accept;

(4) application item belongs to this sectional limits of one‘s functions and powers, all ready, coincidence method decides application material form, or the applicant is referred according to the requirement make good omissions entirely of application material, send " accept advice note " . " accept advice note " ought to build accept special rule and make clear accept date.

Thirteenth province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) examination of management enterprise of medical devices of basis of supervisory administration of medicines and chemical reagents checks and accept a standard to undertake the spot check to planning to do a business, undertake checkup to filing a material according to this method.

The 14th province, municipality, municipality directly under the Central Government (food) supervisory management department of medicines and chemical reagents ought to rise in accepted day make inside 30 weekday whether the nucleus is sent " license of management business of medical devices " decision. Think to accord with a requirement, ought to make allow nucleus send " license of management business of medical devices " decision, remove indrawn applicant 10 days to issue in the day that makes a decision " license of management business of medical devices " . Think not to accord with a requirement, ought to written announcement applicant, show reason, inform an applicant to enjoy the right that application administration is reconsidered or carries lawsuit of politics of start on a journey lawfully at the same time.

The 15th (food) when medicines and chemical reagents supervises management department to undertake checkup to the applicant‘s application, ought to fair show examine and approve process and examine and approve a result. Applicant and interests person can are opposite immediate impact the matter that its weigh golden eggs refers written opinion to have allegation and argue one‘s case.

" license of management business of medical devices " application involves what significant increase concerns between applicant and other directly, (food) the right that medicines and chemical reagents controls management department to ought to inform applicant and interests person to enjoy application hearing of witnesses lawfully.

(food) supervisory management department of medicines and chemical reagents thinks " license of management business of medical devices " involve public interest, ought to to social announcement, hold hearing of witnesses.

The 16th province, municipality, municipality directly under the Central Government (food) supervisory management department of medicines and chemical reagents ought to announce what had issued " license of management business of medical devices " concerned information, the public has authority to undertake inquiring.

The 4th chapter " license of management business of medical devices " change and change hair

The seventeenth " license of management business of medical devices " the modificatory cent of the project is changed to allow item and register item to change.

Permissive item change includes quality administrator, register address of address, scope of operations, storehouse (include storehouse of increase and decrease) change.

Change of the item that register is to point to afore-mentioned item beyond the change of the any other business.

The 18th change " medical devices manages business license " allow item, management enterprise of medical devices ought to fill in " license of management business of medical devices " modificatory requisition, carry occur simultaneously to build this enterprise seal " business charter " and " medical devices manages business license " Xerox.

Change quality administrator, ought to submit letter of the Id that holds the post of quality administrator newly, record of formal schooling at the same time or title certificate photocopy; Modificatory enterprise registers an address, the property right that ought to refer the address after change at the same time proves or rent graph of consultative photocopy, situation, ichnography and memory condition specification; Change scope of operations, ought to refer the specification of the photocopy that plans to manage a product to register card and corresponding memory condition at the same time; Change storehouse address, the property right that ought to refer address of the storehouse after change at the same time proves or rent graph of consultative photocopy, situation, ichnography and memory condition specification.

The 19th medical devices manages an enterprise to apply for to change those who allow item, province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents ought to be in since the day that hears medical devices to manage an enterprise to permit item change to apply for inside 15 weekday according to medical devices management enterprise examines check, and by province, municipality, municipality directly under the Central Government (food) the decision that medicines and chemical reagents controls management department to make allow change perhaps forbid to change; Need spot is acceptable, the decision that allow is changed or prohibits change ought to be made inside 20 weekday since accepted day.

Province, municipality, municipality directly under the Central Government (food) medicines and chemical reagents supervises management department to make allow change a decision, ought to be in " license of management business of medical devices " the content that change records on carbon and time; Forbid to change, ought to written tell an applicant and show reason, inform an applicant to enjoy the right that application administration is reconsidered or carries lawsuit of politics of start on a journey lawfully at the same time.

Management enterprise of medical devices is changed " license of management business of medical devices " after allowing item, ought to change procedures to the concerning that is versed in administration department conduction business registers business lawfully. After change " medical devices manages business license " period of efficacy is changeless.

Management enterprise of the 20th medical devices is managed because of breaking the law already by (food) investigation of put on record of supervisory management department of medicines and chemical reagents, but have not of end a case; Perhaps had received administration to punish a decision, but have not fulfill punishment, province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) medicines and chemical reagents supervises an administration to break down is accepted or ought to examine its " license of management business of medical devices " permissive item changes application, till the case handles end.

Management enterprise of the 21st medical devices is changed " license of management business of medical devices " of the item that register, ought to be in after change of approve of department of industrial and commercial administration inside 30 days fill in " license of management business of medical devices " modificatory requisition, to province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents applies for " license of management business of medical devices " change is registered. Province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents ought to be in since the day that gets modificatory application inside 15 weekday deal with modificatory formalities for its, inform an applicant.

The 22nd " medical devices manages business license " after the item that register is changed, province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents ought to be in " license of management business of medical devices " the content that change records on carbon and time. After change " medical devices manages business license " period of efficacy is changeless.

Component of the 23rd company, amalgamative perhaps cross former administer migratory, ought to apply for afresh according to the regulation of this method " license of management business of medical devices " .

The 24th " license of management business of medical devices " period of efficacy is 5 years. At the expiration of one‘s term of office of period of efficacy, need continues to manage product of medical devices, management enterprise of medical devices ought to be before at the expiration of one‘s term of office of period of efficacy 6 months, to province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents applies for to change hair " license of management business of medical devices " .

Province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents stipulates according to this method trade card applies for to undertake checkup.

Province, municipality, municipality directly under the Central Government (food) supervisory management department of medicines and chemical reagents ought to be in " license of management business of medical devices " make before at the expiration of one‘s term of office of period of efficacy whether its change allow the decision of card. Exceed the time limit did not make a decision, regard as agree to change testimony and grant to fill do corresponding procedure.

Province, municipality, municipality directly under the Central Government (food) medicines and chemical reagents supervises management department to think to accord with a requirement, ought to be in " license of management business of medical devices " give when at the expiration of one‘s term of office change hair new evidence, call in former " license of management business of medical devices " ; Do not accord with a condition, ought to deadline undertakes rectifying and reform, the condition still does not accord with after rectifying and reform, ought to cancel when at the expiration of one‘s term of office of period of efficacy former " license of management business of medical devices " , written tell an applicant and show reason, inform an applicant to enjoy the right that application administration is reconsidered or carries lawsuit of politics of start on a journey lawfully at the same time.

The 25th medical devices manages enterprise losing " license of management business of medical devices " , ought to instantly to (food) medicines and chemical reagents monitors management department report, be in province, municipality, municipality directly under the Central Government (food) publish on the media that supervisory management department of medicines and chemical reagents appoints lost property notice. Province, municipality, municipality directly under the Central Government (food) supervisory management department of medicines and chemical reagents ought to publish in the enterprise since the day of lost property notice full after a month, reissue according to former approve item " license of management business of medical devices " . Reissue " license of management business of medical devices " with former " medical devices manages business license " period of efficacy is identical.

The 5th chapter supervises an examination

The 26th superior (food) supervisory management department of medicines and chemical reagents ought to be strengthened right inferior (food) the supervisory examination that medicines and chemical reagents supervises management department to carry out medical devices to manage a license, correct administration in time to permit the illegal action in carrying out.

The 27th (food) supervisory management department of medicines and chemical reagents ought to be built " license of management business of medical devices " the hair card, job file that changes card, change and the aspect such as supervisory examination, go up in the 1st week general of every quarter quarter " license of management business of medical devices " hair card, change on card, change and the circumstance newspaper such as supervisory examination one course (food) medicines and chemical reagents supervises management department. To becoming invalid lawfully, call in " medical devices manages business license " , province, municipality, municipality directly under the Central Government (food) supervisory management department of medicines and chemical reagents ought to build archives to save 5 years.

The 28th (food) the supervisory examination that medicines and chemical reagents supervises management department to ought to strengthen pair of medical devices to run a company. The main content of supervisory examination includes:

(one) legal representative of company name, industry or chief and quality administrator are fluctuant circumstance;

(2) the enterprise registers address and storehouse address fluctuant circumstance;

(3) condition of business place, memory and basically store circumstance of establishment, equipment;

(4) the execution of the main item such as scope of operations and fluctuant circumstance;

(5) the executive circumstance of system of management of company product quality;

(6) the concerned item that other need inspects.

The 29th supervisory examination can take written examination, spot examination written perhaps the kind that ties with spot examination. Medical devices manages an enterprise to have one of following state, (food) supervisory management department of medicines and chemical reagents must undertake the spot checks:

(one) the enterprise of new start of on one year;

(2) the enterprise of problem of the existence in inspection of on one year;

(3) because violate concerned law, statute, the enterprise that is punished by administration;

(4) (food) the other company that supervisory management department of medicines and chemical reagents thinks to need to undertake the spot is checked.

Thirtieth " license of management business of medical devices " change testimony in those days, supervisory examination and change card to examine can undertake along with all the others.

Thirtieth (food) when medicines and chemical reagents supervises management department to manage an enterprise to undertake supervisory checking to medical devices lawfully, ought to mix the circumstance of supervisory examination processing result on record, by the file after supervisory examination staff signs. (food) medicines and chemical reagents supervises management department ought to announcement is in " license of management business of medical devices " the result that spot examination records on carbon.

Thirtieth has one of following state 2 times, " license of management business of medical devices " cancel by the former office that send card:

(one) " medical devices manages business license " at the expiration of one‘s term of office of period of efficacy did not apply for or did not change testimony permissibly;

(2) management enterprise of medical devices stops what manage or shut lawfully;

(3) " license of management business of medical devices " by lawfully cancel, recall, revoke, call in or announce to disable;

(4) force majeure brings about medical devices to cannot manage an enterprise normally;

(5) the regulation ought to cancel law, code " license of management business of medical devices " other state.

(food) supervisory management department of medicines and chemical reagents is cancelled " license of management business of medical devices " , labour informs of commercial firm politics inside 5 since day weekday that ought to cancel oneself management department, announce to the society.

Responsibility of law of the 6th art of composition

Do sth without authorization of management company of 3 medical devices changes thirtieth of quality administrator, by (food) supervisory management department of medicines and chemical reagents instructs deadline to correct. Refus of exceed the time limit does not correct, place fine 10 thousand yuan below with 5000 yuan of above.

Change of do sth without authorization of management company of 4 medical devices registers thirtieth of address, storehouse address, by (food) supervisory management department of medicines and chemical reagents instructs deadline to correct, give notice of criticism, be in 5000 yuan of above 20 thousand yuan of the following amerce.

Do sth without authorization of management company of 5 medical devices enlarges thirtieth scope of operations, lower management requirement, by (food) supervisory management department of medicines and chemical reagents instructs deadline to correct, give notice of criticism, be in 10 thousand yuan of above 20 thousand yuan of the following amerce.

6 applicants conceal thirtieth to perhaps offer false data to apply for about the circumstance " license of management business of medical devices " , province, municipality, municipality directly under the Central Government (food) the city level that medicines and chemical reagents monitors management department to perhaps accept precatory to establish a division (food) supervisory administration of medicines and chemical reagents is accepted to applying for not to grant or do not grant the nucleus is sent " license of management business of medical devices " , give a warning. The applicant must not apply for again inside 1 year " license of management business of medical devices " .

Thirtieth 7 applicants are obtained with the wrong step such as deceit, bribery " license of management business of medical devices " , (food) medicines and chemical reagents supervises management department ought to cancel its " license of management business of medical devices " , give a warning, be in 10 thousand yuan of above 20 thousand yuan of the following amerce. The applicant must not apply for again inside 3 years " license of management business of medical devices " .

8 medical devices manage thirtieth the enterprise has one of following action, (food) supervisory management department of medicines and chemical reagents ought to instruct deadline to correct, give a warning; Refus of exceed the time limit does not correct, place fine 20 thousand yuan below with 10 thousand yuan of above:

(one) alter, buy in and sell at a profit, rental, lend " license of management business of medical devices " perhaps make over illegally with other form " license of management business of medical devices " ;

(2) surmount " license of management business of medical devices " stated scope of operations develops management activity;

(3) concerned condition is concealed in supervisory examination, offer false data to perhaps reject to provide the real data that reflects its to manage a case.

Thirtieth is in 9 times " license of management business of medical devices " hair card, change card, change and there is the other state that offends relevant law, code to set in supervisory management, according to the formulary processing of concerned law, code.

Supplementary articles of the 7th chapter

The 40th " license of management business of medical devices " include original and copy. " license of management business of medical devices " original and carbon have coequal law effectiveness. " medical devices manages business license " original ought to the marked place that park medical devices runs an enterprise to run a place.

" license of management business of medical devices " ought to carry legal representative of bright company name, industry, controller and quality administrator full name, scope of operations, register address of address, storehouse, licence the project such as date of card of mechanism of card of date of date, licence running water, hair, hair, period of validity.

The 41st " license of management business of medical devices " by national provision medicines and chemical reagents supervisory management board is united print. " medical devices manages business license " style of original, carbon and number method, by national provision medicines and chemical reagents supervisory management board is united make.

This the 42nd method is carried out since the day that announce. Supervisory management board of national medicines and chemical reagents makes the 19th " management enterprise of medical devices supervises administrative measure " abolish at the same time.