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Health care policy changes and market impact on medical practice – antibiotic management policy impact analysis
The new policy, I think we will be here many, many companies feel the immediate impact of antimicrobial drugs is now so strict control of our future operations, sales and even the layout of the target market to see how, probably will have some impact. The introduction of the policy background, this topic has been talked about at least three or four years, said the Chinese anti-bacterial medicinal too, and my impression that a lot of data we use antibiotics used to say simply outrageous. So that together, the actual drug resistance (English) also has a lot of problems out.
Practical point of view has been from the Ministry of Health wants to limit this thing, but also for many years, at least three or four years, in that we can do anything to limit the children these things. Practice has proved that in the end, in fact, this trend has not changed over the past ten years there, first of antibiotics has been China\\ s largest market, growth has been quickly the second, third antibiotic sales which, we are all peers, antibiotic sales behind the trick is simply endless, and the amount actually be the last of our own business is now injured, said antibiotics do it too difficult to do this thing, the trade rumors and even 80% of the rebate can give to the hands of doctors, We do antibiotics pharmaceutical companies are also injured.
Now we want to change this situation, how? In fact, from the whole, from policy trends, of course, not just that this year, out of the new policy to go along with this idea, in fact, the Ministry of Health has been thought to antibiotics is a three-pronged management, from the variety of restrictions on how, medication specification how to get to the so-called hierarchical management how to implement the program. In fact, so far this year, there are the so-called management approach them. Are limited to the original direction, policy, has been missing is the specific management measures, on one level in the end how do you manage this one thing, he saw the results, of course, many of us, including this time the new medical reform, the entire down there a lot of new things, ideas many, many ways, the policy number, how to perform the last fact missing. Has always been the problem. This time this year, in April this year, I feel the introduction of a policy, you see the direction it actually has not changed, the emphasis is the specific implementation, which in the end how to do a management. Not a few months out in April, August, and we know that a policy out of its adjustment, the actual implementation you see down, the Ministry of Health determined that there is a certain time, in the end how to change it, say within four months of the original policies should be revised, is the level of policy implementation in many parts of the original or not perform, he is willing to change it again.
Later, under the new policy, said in August down how the implementation of the future, we all like each (in English) do visit, we will feel really slow to implement, because it involves too many things too much. Such as species limits, a bit like our price, this is set, the best execution, we see that city, began to go large hospitals, the top three hospitals in Guangzhou are not started, but in Shanghai, Beijing started. In fact, we see companies in this regard, public relations at the hospital level, which significantly increased, which is now seen. In fact, now that August day out which was the final analysis, the hospital did not begin enforcement of the deadline, the deadline where this figure which we thought, we talking about, when implemented, probably have a while.
There is power together, we actually see is a general concept of income. Each hospital has a dedicated management committee called the antibiotics, or should they decide to open. Patients in the ICU, where you think, to use a special class of antibiotics, if not in charge of its two expert how should we do, in fact, many issues are still to look at. Interpretation of the policy a little bit, if we do business we are very familiar with antibiotics, a variety of restrictions on the most obvious limitation is the amount required, three hospitals 50 varieties and two hospitals thirty-five kinds of concepts, what is the situation now ? A larger type of the top three hospitals in 99 kinds of antibiotics, two hospitals and some up to more than one hundred kinds now reduced to 35 kinds. And must be done, the President should be held responsible. Varieties do it if I feel it should soon. Norms that are classified, so-called ordinary medication. What types of different situations of antibiotics, use of antibiotics in fact the worst is in front, is one, the direction of policy change now that the management of this class of drugs to be more strict. Such as penicillin, the original was open now and it was open, policy analysis point of view may not be able to misuse of antibiotics for this one thing reversed. Of course there are some very specific things, what kind of situation, especially a class of antibiotics that prevent the incision together, this is particularly evident in the decline, because a lot of this together with the original, this time together to do a lot for this restrictions. Hierarchical management concept I mentioned earlier, in fact, originally I was just non-restricted, restricted, restricted officers can use the above signatures are basically, but this time said no, I would add a special class of medication, that the original director sign on the line, must now be approved by the hospital management committee of antibiotics, this one actually operate in big trouble, a special class of medication, in fact, most of our foreign agents, such as our fungus medication, in practice there will be some difficulties, a little later we will see a lot of doctors now say how to do, where or not to save the patient, the actual hospital to discuss how this is to do this thing.
We expect the strength in accordance with the Ministry of Health are now talking about the fact that their determination, we expect a variety of restrictions that a child will soon be on our direct impact, if each company there are antibiotics in hand, the first things children say one thing to do this quickly, this is a truth for us is the survival of this species limits entered into, and out of the hospital as early as possible to give up, not you, not to say that once a medication how, basically want to say again the next time. Of course, there are special circumstances that you are purchasing the so-called temporary, this one is every hospital can do, but provides more than five times the next time you have to enter, or not set up this temporary purchases, a little gap, you see this one I think children need to do early, early varieties of line must be done.
There together with the original words related to the antibiotics, we have patents together, no problems have basically no generic drugs, in general more favorable. Relatively speaking, I think it is beneficial.
Top three hospitals in major cities now have taken antibiotics in the management committee, they have begun to do this one thing. But Chengdu, the three general hospitals began to do this are not many children. Now look at the management of the Ministry of Health, the speed should be fast, requiring hospitals to do.
In the hierarchical management that together, basically where specific policies which have medicinal requirements. Restricted special treatment to this level, this is a new level, this time the hospital has a great decision-making power, the advantage we are doing (in English) This is the level of division together, there are many drugs, the general limit of the special treatment can go, due to special drug approval process less complicated this together, I think (English) has a thing to do is (in English) above should also have some things to do.
Drugs to regulate these together, in fact, different surgical scale prevention, surgery is the prevention of the finest speakers, and even that surgery should prevent surgery hours between 30 minutes of surgery, should return to this category. So that specific management measures above are some very specific requirements. This is the actual medicine the doctor together will have an impact, to be honest with little effect on clinicians because the clinical, preventive medication classes most of the prevention of drug selection is a kind of habit, habit out of medicine, To be honest the new management system basically are allowed, only possible on the original master of this operation time is not so strict, must now be serious some, I think the difference is probably in this one aspect.
This is what the new policy together what kind of direction. We look at this policy for the entire so-called acts of our market what kind of impact, I think the biggest impact to see a doctor hands the power to imagine the future, this policy environment, a doctor will hand power to a small a small lot, especially in the drug selection of species, because you see the policy implications are basically limited variety of antibiotics, there is no relationship, and what you can influence. Rational use of drugs provides some surgery now can be used in accordance with the provisions of the original is not available, this one a great impact. Total control medication, tell the truth in each hospital had its own health insurance which, we also had to do this, the total control of impact, but should not be so great, because the doctor or the hands of the so-called flexibility. Surgical clinical pathway itself does not exist to tell the truth, medical treatment will have some impact but the impact on the basic few. The first clinical pathways, clinical pathways we have now a total of 20 in accordance with the rules of clinical disease path, and it basically does not recognize a national health insurance, most of the antibiotics used in clinical pathways, the Ministry of Health said there is no honest way to be, Basically no impact. This is from the policy level impact on the overall market analysis from several aspects.
The clinicians point of view, the actual medical treatment options will be limited, because fewer species, the original practice of using some of the drug habit or even prefer some of the brands, there are basic, no no, the choice of special medical treatment effect will that have on. Management at different levels, the average doctor will say that I go is so original, so there is no effect. Medicine will have some impact here, actually you see such a doctor complaining of personalized treatment for different patients how to pick these things are gone. This fact, together I think there are good and bad. For us, are generally said to establish the brand concept, and establish my (English) concept, but where this policy will also affect the choice of medical drugs, which together more of our (English) challenge, how this part of the future do, how to consider medication management under the framework can then talk about our brand.
Proportion of drug control has no effect, as has been doing, no matter what level of restrictions, had no effect.
In fact, the total reflection surface do more to make a fuss. Practice of doctors, the patient no good. Basically good, these restrictions are, the sick dancing, more and more disease. Doctors do not think much. I say enough of how many hospitals so much? He said that in full accordance with the provisions of 35 kinds is enough, but every doctor has to understand every doctor, every person has the choice of each person. He said the antibiotics, he also agreed to the use of sucks, but the problem lie? Level is not enough doctors, not make the right judgments, and have actually called the Ministry of Health to manage not solve this fundamental problem.
We look good, specific these effects are basically the first restriction that the so-called species together, which together tone of each hospital, all doctors we are the first execution, after the adjustment, acquire this number down to pay the difference, the latter how to do it again, have a look at the problem. The concept is so basic. Here the greatest impact on surgical prophylaxis for surgery, we say that this in itself does not require too many, with the only saying that the original from the 50 cephalosporins which can be selected from the two inside the election now, they will not feel much of a problem. Medicine greatest impact. Where is the largest? Like breathing, blood in this class sections, they are all using more high-end antibiotics, under the New Deal are essentially management, especially the strict set of procedures such as the use of drugs, will have a significant impact on them. Most medical departments to reflect the patient is not good for us so bad, in fact, is that this one thing wrong, of course, in practice, as we talk with the Department of Respiratory Medicine, Department of Hematology talk, they think this thing is not so large impact, basic antibiotics in the hospital management committee composed of, in particular, are basically the two leading sections of the people, will be a good sign to sign, should have little effect, so from this point on should be able to, but now power up close, receiving hospital, this will not be rent-seeking and out, a new round hotbed of corruption, kickbacks, said most antibiotics, and now power up close do not know which one will have to take a lot of money, most doctors would look at the limit .
Impact on the market, the variety should be the maximum limit impact on the market. In terms of foreign species selection, selection criteria actually see behind me is the amount of the first, small manufacturers in the inside, the greatest impact on small manufacturers. Certainly increase the amount of the original hundreds, now thirty-five ten kinds of usage will increase, in general, I think it\\ s more beneficial to a number of species limits.
Standard real impact here, one is the prevention of where you choose what you choose so little, that the original surgery that together we all use their own medication, this should also okay. In terms of medicine, but also, you walk down to see all levels of the specific drug is not significantly affected. In fact, what you see is missing this together, the whole New Deal down, I personally agree with the doctor\\ s education is most important, specific restrictions on these things I can not see this one thing and antibiotic usage can be pressed down. There are three generations of insurance, including anti-fungal that together, the market should be more smaller. From the program management process, a lot of antibiotics is the original ladder, where a lot of time into the path more willing, I think there will be some impact.
This segment together, before the implementation of the so-called, where up second-generation with the new rules down can only use second-generation cephalosporin. The next generation of New Deal can only use it for good with a generation. This is considered a type of medication. Types of medical management at different levels with a little more, less restrictions, this special class together, because to the Board for approval, which together I think it will perform, together with this special class will perform a deeper, non-prescription signed decision will not change much, because most critically ill patients in these departments, to manage their own job is to lead, not too restrictive for them.
Together to prevent this is will be much affected. Because most of the varieties would be affected. Basically, you see that a good market, in the end what the impact of a general hospital that you have to do this thing, cut from the original 90,120 to 90,35 how reduced, the general said the first thing to do, we There are 100 kinds, with all the weed out less, which together directly affect small and medium enterprises, our so-called small products, a similar but do little peril, because the hospital there is no room for bargaining, basic across the board, then is not a class of drugs of various types of state regulations inconsistent with the state to change over, this is the second child to do things, and the third thing is to consider the children how to regulate a specific product, and domestic and imported how do you balance the total The view will follow the basic high-level antibiotic has been used in recent years. And feedback from primary care doctors, too, which could do with our relationship the way different products, there is still some difference between the brand, this time I feel that every hospital in the so-called concept of a domestic imports of the above, there will be a consideration, then consider the price factor, this time it is difficult to consider, you have only two options for a price like this, to be honest there is no competition. We are also listed, in fact, the most important thing is that few, that is, product regulation, in the present market share, the size of the market capacity, as well as national regulations. The state has said this is a new special class of drugs, which together let me in the hospital level to address, we said yes, there are a lot of work to do.
It looked different types together what, in this case is a special case has been how to get out. Just now we talked a lot, the Chinese market very, very good, how kind of the direction of health reform, how kind of policy, we would like to say well I see a specific policy in the short term, the market conduct of the doctors have any effect, I hope shed some light on you, our market strategy to help make the product measure, we will see that in fact the policy analysis, policy implications, I think it is necessary to support the content. Changes in the macroeconomic environment in the market for a product focus is the recent influential. Here is my contact information, we can communicate back, thank you.
Growth in demand for home medical equipment, life-changing health care
Advanced semiconductor technology makes medical devices get smaller and more powerful, or even home use. For patients, this means that medical care more convenient, outpatient visits less and less, getting lower and lower medical costs. However, to use at home, medical equipment must be simple, safe, and can even withstand misuse, and can distinguish between right and wrong results the results of the program.
As the aging population, home health care equipment demand expansion. According to WHO data, the population over the age of 60 in 2006 reached 650 million, is expected by 2025 this figure will reach 1.2 billion. Currently focused on semiconductor development areas of home entertainment and communications and handheld consumer electronic devices.
This type of design experience and even some of the devices on the new generation of home health care equipment, the implementation is useful. When the technology level and high-performance instrumentation with sensors and data acquisition devices, the final product can be built into the medical-grade system, and easily deployed in the home. Precise and reliable, high-performance semiconductor products include sensors, amplifiers and data converters, which is used to extract precision and digital signal; and embedded processors, used to perform complex analysis of signal acquisition.
Sensor
Current diagnostic measurement system is based on integrated solutions and monitoring specific targets related to the clinical material. Measurement system consists of a detection layer, used to identify the target material, and generates biochemical signals measured by the sensor. An example of this technique is the blood glucose testing. Glucose test strips on the enzyme selectively converts glucose measurable substance. This process, the resulting electronic and proportional to glucose levels.
These electrons can be used to measure based on current meter. Silicon capacitive sensors including digital converter, digital converter impedance, LED-based photonic systems, photodiodes, MEMS-based motion sensor (for measuring acceleration, gravity and tilt) and the gyro sensor for detecting rotation.
Data converters
The signal processing module often used in conjunction with high-precision amplifier can drive the sensor and the digital conversion. ADC and other products can achieve low power, high accuracy system. Successive approximation register (SAR) and the Σ-Δ converter is required for the resolution of these systems and the measurement signal bandwidth.
Embedded processing and wireless communication
Want in the clinical environment to provide a compact, battery-powered medical diagnostic and monitoring applications that require high performance, low power, low cost and secure embedded processing. Embedded processor analyzes the collected signal, first verify the quality and signals into the medical information available, and then format the results can be passed to the patients, while the control device.
Processor can also be used to manage wireless (or wired) connection to the patient data to physicians. Not difficult to imagine, you can design a watch-type device, a non-invasive ways to monitor vital signs. For developers who want the lowest system cost and power consumption based on the improved performance, consider the integration of DSP and microcontroller, such as ADI\\ s Blackfin. ADI\\ s recently launched radio SoC combines data conversion, RF and 32-bit processing power, providing power-efficient wireless connections.
Ideal for high noise environments must be quickly capture, measurement, and send data, but not allowed to consume a lot of battery power medical applications. For example, patients wear a wireless Holter or telemetry monitor must be very small, able to work long-term low-power battery-dependent, and have a high enough level of performance that can continuously transmit the patient\\ s vital signs. ADuCRF101 support these applications, but also in the care of patients outside the hospital environment.
Existing home health care equipment
Examples of home healthcare equipment are: Night lung monitor Wholter, personal asthma assessment equipment Wheezometer, two products developed by Israel Karmelsonix. Wholter and Wheezometer meet the world\\ s 48 million asthma needs assessment and control of disease, but only by the patient before surgery or hospital to get treatment.
Must be immediately effective and accurate assessment of asthma, in order to provide the basis for appropriate medical measures. In the past, only the hospital or operating room of the spirometer before has such a high reliability. To the medical technology transfer from the hospital to home, Karmelsonix ADI\\ s BlackfinDSP and other precision signal processing devices, to ensure that asthma patients have access to accurate and reliable \"breathing rate\" (an important indicator of an asthma attack) assessment information.
The forms of Chinese medical device industry outlook
medical device industry, as opposed to R & D for new drugs, indulge in fast track, and China is relatively backward areas of medical devices, is also inadequate allocation of resources, coupled with new support for health reform in the diagnosis, imaginative space for future growth. At present, China\\ s medical equipment market capacity of only 100 billion yuan, compared with drugs, only about 10% of medicines, while in developed countries, close to 1:1. Additionally, the annual growth rate in recent years, the medical device market are more than 20%, so by the investors. But somewhat low-end product structure, industry size is limited, but also widely criticized. Tree of Heaven is also rooted in the soil, this paper from the current format of domestic medical device industry perspective, to provide some reference point.
China\\ s medical device industry formats and future development
The so-called format, which form the industry, that is a development of the industry\\ s overall size, trends, structure and layout characteristics.
Although the number of Chinese medical device companies to more than 20,000, only export up to 16,000 businesses in 2011 is expected to export 150 billion U.S. dollars. However, China\\ s medical device products is still the basic low-end products, such as cotton wool, gauze, bandages, disposable syringes, ultrasound, X-ray and monitors, etc., of which foreign investment and joint ventures accounted for about half of exports. Thus, our domestic medical device companies and the overall situation is not optimistic.
Although low-end products based product structure widely criticized, but any development of the industry, are inseparable from the overall format environment. Low-end products of the forms, precisely because the current actual situation. If immediately launched high-end medical products, such as magnetic resonance imaging (MRI), PET / CT, etc., and not realistic. With proof that doing business in low-end products, live more moisture, and do so-called high-end products companies, most of the living is not easy. The reason is that, in the current format high-end products of domestic enterprises have not yet fully formed, is not capable of producing high-end products of the soil. High-end medical equipment areas covered a very wide range, from precision processing, imaging, biochemical products, new materials, software development, continued investment in capital and other requirements are very high. Although it is a product that is actually less than a complete industrial chain innovation. If some high-end accessories rely on imports, on the one hand, Vice value-added products declined significantly, the cost advantage is difficult to embody. Even some high-end accessories, imports are still many restrictions. Thus, the domestic production of these high-end medical equipment, will face mangled situation. If you try to break through the various bottlenecks, but also non-overnight. Even at this stage, we have some high-end medical breakthrough, but the rapid rate of replacement of high-end products, R & D investment is quite amazing, are often the result is that we finally developed, but has long been out of the market, there is no market support, out of the question follow-up research and development.
All in all, in the current environment of China\\ s medical device formats, and take a solid upgrade path more appropriate. Industrial base from the start with Chinese characteristics, combined with China\\ s cost, human resources and market advantages, gradually moving from low to high end. Such as Mindray, made medical devices and electronic products are mostly related, in fact, the domestic electronics products through 20 years of development, a strong foundation and infrastructure, supporting complete industrial chain. Coupled with international recognition of China\\ s electronic products is high, easy access to international markets, but also easier to form a competitive advantage. On this basis, step by step through cooperation, mergers and acquisitions, innovation, OEM and other means, to seek innovation and development, escalation, and ultimately the establishment of China high-end medical equipment industry formats. Once the high-end industrial format established, it is the equivalent of a good soil, trees towering achievement is a natural thing.
Circle Medical Devices Construction and structural upgrades
Format of form, not a single business can be completed. Required upstream and downstream sectors as well as supporting a full sound, and join forces, and ultimately the formation of an industry format.
Currently, the majority of the domestic medical equipment alone. Medical devices with the traditional drug development is indeed different from a chain drug development, very close, have specialized in drug screening, and have engaged in pre-clinical trials, but also in clinical trials, as well as registration approval, intellectual property, outsourcing of production and so on. However, all medical device companies often assume all functions, including research and development, approval, production, sales and other train. Many categories of medical devices, but the correlation between too few businesses. Also, many medical device product technical content is not too high, easy to imitate, so, some companies also worry about leaks and other risks. If the industrial park, based on a number of traditional industries with local advantages, such as some of the regional electronics industry, a good foundation, or basis for precision machining, mold or foundation, or basis for new materials, etc., which pave the way for the industrial base to create a close link with Circle Medical Devices format is quite good. Meanwhile, upstream and downstream of the collaboration, but also to avoid product homogeneity, and low vicious competition there.
Indeed, many areas in China, has formed a unique medical device rings, such as Shenzhen Nanshan, Changzhou, Jiangsu, Shandong and other places, these areas of medical devices has begun to take shape. Many parts of the biomedical industry park will also attract investment as a key target of medical devices. However, on the whole, but also the lack of medical device industry format of the macro layout, especially high-end medical equipment to build the forms. China to enhance the medical device industry as a whole, not individual companies to enhance, but the entire industry chain to enhance the forms in order to realize the structural upgrade.
Internationally, such as Ireland, Germany Duse Fu is well-known medical device industry base, has a very complete industrial chain, from product design, new materials and new product development, processing and have different business commitment, close collaboration between enterprises. At the same time formed a \"multi-area\" situation, that is a leading business, drive around the dozens, or even more business for the production of parts, or OEM.
Ministry of Health: Medical problems do not take the initiative to recall the severe penalties
Closely related with people\\ s health is a problem if the medical device, medical device manufacturers must implement the recall. \"Medical Device Recall Management (tentative)\" (hereinafter referred to as the \"Rules\") by the Ministry of Health issued Decree No. 82, came into effect from this month. Reporters learned that the \"measures\" after the implementation of a security risk rather than a voluntary recall of medical devices companies will be punished severely. Medical device recall if harm to patients, patients can seek compensation.
What kind of medical equipment to recall
\"Under normal use, there is likely to endanger human health and safety of the unreasonable risk of medical devices\", are in the \"measures\" referred to recall.
Medical device recall, is the medical device manufacturer in accordance with the procedures provided for its sale of the defects have been of a class, type or batch of products, to take warning, inspection, repair, re-label, modify and improve the specification, software upgrades, replacement, recovery, destruction, etc. to eliminate defects in behavior.
medical equipment manufacturers to control and eliminate the main defects should be responsible for the safety of their products. Medical device manufacturers should be required to establish and improve medical device recall system, the safety of medical devices to collect information on defective medical devices may investigate, evaluate, and timely recall of defective medical devices.
Medical equipment enterprises, and use that their operation, use of defective medical devices, shall immediately suspend the sale or use of the medical device, medical device manufacturers promptly notify the supplier or to the drug regulatory department reports; use units medical institutions, should also be reported to health administration departments at the same time.
China will no longer be excluded from the recall beyond
Because this approach applies to \"sales in the PRC, the recall of medical devices and monitoring management\", which means that also applies to imports of medical equipment. Experts believe that this will regulate the multinational medical device companies in China to recall.
According to publicly available data, 2010, the total output value of China\\ s medical equipment breaking hundreds of billions, but, more than the local device company focused on the consumption of conventional varieties of low-end market, NMR, CT high value-added of large equipment market was almost GE, Siemens Philips and other foreign companies to monopolize. \"Measures\" after the implementation, including Johnson & Johnson, including a number of multinational companies in the global recall of Yi Xie, China can no longer take exception to the grounds of relief recall responsibilities.
This, according to the \"measures\" requirements, the import of medical equipment manufacturers in the extraterritorial application of foreign medical device recall, it shall notify the designated agent in China SFDA and timely reports; in the territory of the recall, must be specified by its agent in China responsible for implementing required.
Municipal food and drug regulatory authorities, the officials said, this one will help to eliminate some of the medical devices multinational corporations engaged in international product recall, the Chinese exclusion phenomenon.
Found that enterprises should take the initiative to recall defective
Medical device manufacturers to investigate the required assessment, medical equipment found defective shall be immediately decided to recall.
Imports of medical equipment manufacturers in the extraterritorial application of foreign medical device recall, it shall notify the designated agent in China to timely report State Food and Drug Administration; in the territory of the recall, by its designated agent in China accordance with the provisions to be responsible for implementation.
Recall notice should at least include the following: medical device recall the name, batch and other basic information; the reasons for the recall; recall requirements: such as an immediate moratorium on the sale and use of the product recall notice will be forwarded to the relevant enterprises or use of units; recalled medical devices are handled.
Companies to re-recall recall is not complete
Drug administration departments can organize experts based on the actual situation of medical device manufacturers to submit plans to assess the recall, medical device manufacturers that the measures taken to eliminate the defects can not be effective, medical device manufacturers should be required to improve the recall level, expand the scope of the recall, shorter recall time or change the handling of product recalls and other more effective measures.
Medical equipment manufacturers medical equipment for the handling of the recall should have detailed records, and medical device manufacturers and drug regulatory department. Through warning, inspection, repair, re-label, modify and improve the specification, software upgrades, replacement, destruction, etc. to eliminate product defects, and can complete the above location in the product behavior. To destroy, should be destroyed to drug regulatory department under the supervision of the destruction.
Drug regulatory authorities to evaluate the effect of the recall. After review and evaluation, that the recall is not complete, yet effective to eliminate defects, the drug regulatory department of medical device manufacturers should be required to re-recall.
Drug regulatory authorities the right to order the recall
After investigation, drug regulatory authorities assessed that defective medical device manufacturers should be recalled without active medical device recall, it shall order the recall of medical device manufacturers of medical devices.
If necessary, the drug regulatory department shall require medical device manufacturers, enterprises and the use of units immediately suspend sales or use to inform the user immediately suspend use of the medical device.
Drug Administration ordered the recall to make the decision, shall order the recall notice on the import of medical equipment manufacturers medical equipment manufacturers or domestic agents. Medical device manufacturers receive compulsory recall notice, shall be required to notify the medical device business units or enterprises and inform the user to use, develop, submit the recall plan, and organize the implementation.
Was ordered to recall the \"severely punished\"
Defective medical devices, companies active recall, can be \"lenient.\" However, if the violation of the \"Rules\", found that medical devices do not take the initiative to recall a security risk, and once by the drug regulatory department shall order the recall, will be \"severely punished.\"
As a rule, the drug regulatory authority to confirm medical device manufacturer for breach of laws, regulations, rules and regulations resulting in defective medical device market, which shall be given administrative punishment, but the companies have taken proactive measures to eliminate or reduce recall harmful consequences, according to \"Administrative Punishment Law,\" a lighter or mitigated punishment; offense is minor and promptly corrected, did not result in harmful consequences, not punishment.
Medical device manufacturer in violation of the provisions found in medical devices and not take the initiative to recall defective medical devices, ordered the recall of medical devices, medical device recalls and impose the value should be 3 times the amount of the fine; serious consequences, from the the original issuing department shall revoke the certificate of medical device product registration, or revoke \"Medical Device Manufacturing Enterprise License.\"
Medical device manufacturers refuse to recall medical devices, medical equipment at the value should be recalled three times the amount of fines; serious consequences, the original issuing department shall revoke the certificate of medical device product registration, or revoke \"Medical Device Manufacturing Enterprise License witness. \"
Recall of medical devices to patients with damage, patients can seek compensation to the manufacturers, medical device can also operate businesses, and use to seek compensation. Patients to medical equipment enterprises, and use the request for compensation, medical equipment enterprises, and use of compensation, the right to the production company responsible for recovery.
Health care reform boost digital medical imaging products to a new level
Digital medical imaging equipment to upgrade the equipment as traditional products, from traditional photo imaging as the only carrier in order to achieve a digital image output, processing, storage and network transmission and other functions, greatly improving the efficiency and accuracy of imaging . One, CR (Computer Radiography) and DR (Digital Radiography) as the main digital flat panel X-ray imaging equipment in China has begun to be widely used.
According to the China International Bidding Data, the first half of January to June, China\\ s CR through an international tender for procurement of a total of nine, winning project involved a total of $ 7,663,000, of which seven are multi-slot CR. As with conventional X-ray machine to upgrade to digital transformation of the product, CR imaging systems in the ten years after its launch, as readers continue to improve and increase image resolution IP board, as well as product prices continue to drop, coupled with its without the original X-ray generator and the projective bed to make any changes, reducing the cost of the transformation of the hospital, etc., by the radiology community in general. Which, due to multi-slot CR mechanism automatically slides the use of technology to reduce time-slot CR films of human input and also saves the time to re-enter patient data. Therefore, the multi-slot CR CR is gradually replacing the Single market dominance and become the new darling of CR market.
In addition, as a direct digital technology, the DR is through the human body by X-ray projected onto the flat panel detector (referred to as the DR board) direct access to digital image signals to the collection of images, the image quality is better than CR. Meanwhile, the image acquisition speed also greatly improved, therefore, the market is very promising. The first half of January to June, China through an international tender for procurement of a total of 86 sets of DR involving a total of $ 33,640,500 project successful. Be floating over the previous year.
Since the introduction of our first CR, the formal entry into the traditional flat-panel X-ray imaging to digital transition. In the beginning of the transition, due to constraints of the level of economic development, digital medical equipment with an impact on the high price of the digital transformation of health care institutions to a major obstacle. With China\\ s rapid economic development during the arrival and introduction of health care reform policies, the number began to accelerate the pace of health care. Also, because China is the world\\ s most populous country, the number of hospital outpatient day far more than the number of foreign hospitals, outpatient, which makes digital medical imaging equipment advantage of short image acquisition has become more prominent, in order to meet the patient\\ s inspection needs, which is bound to promote the hospital to speed up the pace of reform of digital. In the past decade, digital medical imaging products continue to lower prices, but also more and more hospitals have the ability to buy, it all becomes another forward the reform of China\\ s digital medical accelerator.
China\\ s \"Eleventh Five-Year Plan\" clear that the \"Eleventh Five-Year\" period will further increase investment in health care, focusing on public health, rural health and community health, the establishment of the health system to prevent major diseases. These relatively backward as our current health care and medical sectors, the start of its reform plan, is bound to bring medical equipment procurement market to heat up. Digital medical imaging products as the leading medical equipment market, it must benefit.
TI for medical imaging applications to provide the best noise performance and low power ADC
Texas Instruments Incorporated (TI) announced the industry s best noise performance with minimum power consumption of 80MSPS, 8-channel 14-bit ADC (ADC). The ADS5294 can be 5MHz to support 75.5dBFS best signal to noise ratio (SNR), the sampling rates up to 80MSPS, fully meet the designer of the high power efficiency and low cost designs. ADS5294 at 80MSPS and can provide high performance under 77mW per channel, the lowest power consumption, integrated digital processing block, low-frequency noise suppression mode, and programmable input to output mapping function. All of these features can help the designer in a smaller package to integrate more features to the development of smaller medical imaging systems.
Key features and benefits
Industry-leading low-power low-noise performance: ADS5294 provides best-of SNR, can help designers of high-density applications without increasing power consumption in case of increased number of channels;
5MHz/80MSPS when the SNR is 75.5dBFS
5MHz and the decimation filter is enabled when the SNR is 78.2dBFS
SFDR of 84dBc at 5MHz/80MSPS
Under the power per channel 80MSPS 77mW (two per channel LVDS line)
Low-frequency noise suppression mode
Digital processing blocks integrated system of several commonly used functions, such as 2, 4 or 8 filter with dual-channel or 4 channel average or extraction function;
Digital processing block can be used to greatly enhance the SNR and harmonic filters, narrow-band applications, while reducing the output data rate;
Dual LVDS interface: The ADS5294, the digital data available for each single or dual channel LVDS output pins to reduce the number of interface lines. This will create a two-wire interface, serial data rates to maintain low to enable designers to use low-cost FPGA;
In addition to medical imaging systems outside, ADS5294 also for radar, communications, test and measurement, and other multi-channel data acquisition applications bring the same advantages.
Availability and Packaging
12 mm x12 mm, 80-pin QFP package ADS5294 is available now.
Tools and Support
To test the ADS5294 under a variety of situations to provide flexible environments, evaluation boards now (EVM) has started to provide. ADS5294EVM can be ordered through the following site.
Verify circuit board signal integrity requirements of IBIS models are available now.
Highly optimized simulation products and a full range of products medical applications
ADS5294 is optimized for TI s analog products, the newest member, designed to meet the medical imaging systems and other medical applications. Include:
Ultrasound: Ultrasound applications AFE58xx family for analog front end for handheld systems AFE5801 and AFE5851, for portable to mid-range systems AFE5805 and AFE5804, and high-end ultrasound systems AFE5807 and AFE5808.
TITX810T / R switch on the transmitter all the complementary products;
ECG / EEG: ADS1298 series of front-end for the electrocardiogram (ECG), electroencephalogram (EEG) and other patient care applications to bring the highest integration and lowest power consumption.
TI s full range of medical applications, including semiconductor products and other embedded DSP and MCU processor, rich analog signal chain, power management and wireless connectivity solutions to help manufacturers accelerate the medical electronics market.
China is expected to become the world s largest medical device market
Fuji Photo Film (China) Investment Co., the former vice president of 27 Goto Tanigaki said, as China\\ s accelerated urbanization in rural areas and expanding middle class, China is expected in the future to become the world\\ s largest medical device market.
Goto radiation in the 2011 academic year in North America during an interview with reporters, said it is optimistic about China\\ s medical device market, General Electric (GE), Siemens and Philips, the world giant in the medical field on the layout of the 1990s, China market, Hitachi, Toshiba and other Japanese manufacturers are the late 1990s into the Chinese market. Recently, due to appreciation of the yen, export medical devices to reduce profits, many Japanese companies to invest in China began to accelerate speed to market.
Goto said, at the same time, China\\ s local enterprises is also increasing. Five years ago, not a Chinese company will participate in academic radiology in North America. This year, attend the annual meeting of Chinese enterprises reached more than 10, hundreds of participants.
2011 school year will be the North American radiation from 25 to 30 in Chicago McCormick Convention Center, attracting 60,000 from around the world industry participants.
Talking about health care reform in rural China and rural urbanization impact on the medical device market, Goto said, the acceleration of urbanization in rural areas led to the proliferation of small towns, people increase the demand for medical care. However, due to the small town of resources and medical qualifications of doctors as large cities, the popularity of the Internet gave birth to a business opportunity: small town doctor can be taken through the network spread to large hospitals, medical images, physicians, hospitals, large physician from the diagnosis of views. He disclosed that the company is currently in progress in this regard Fuji attempt, cooperation with local enterprises in China, for small towns to provide medical diagnostic products and services.
Goto Tanigaki stepped down in January this year to return after he was responsible for business in China for seven years.
Local medical device companies should pay attention to trends in international law
November 25, SGS-CSTC Standards Technical Services Co., Ltd. (hereinafter referred to as \"SGS\") together Shenzhen medical device Industry Association, held in Shenzhen, the international medical market access seminars.
International medical device market in recent years the rapid expansion and growth in demand for medical products, to promote China\\ s medical device industry has made leaps and bounds, and with the expansion of exports, exports of medical equipment is increasingly faced with the importing country and customer\\ s new requirements, foreign clients pay more attention to medical equipment and parts quality is good or bad, they continue to require manufacturers and suppliers to provide the best quality products. Meanwhile, exports of medical equipment in the various countries will face different market access requirements, these requirements which, the development trend of enterprises how to deal with, how to get the importing country\\ s market access? From the interpretation of the international export market access seminars countries face different regulations start, the medical device companies for the domestic regulatory trends analysis to explore the coping strategies of enterprises.
Currently, the global pharmaceutical and medical device consumer ratio is about 10:7, while Europe and other developed countries has reached 1:1.02, the global medical device market has accounted for the international pharmaceutical market 42% of the total scale, and expanding. Industrial output value of China\\ s medical equipment in 2010 exceeded 100 billion yuan mark for the first time, many medical device production scale ranks first in the world. In 2010, China\\ s exports of medical products for the month were $ 1.225 billion in November and December exports are exceeded $ 1.4 billion, that the international market for medical products in China increasingly dependent on high. These factors are the rapid development of China\\ s exports of medical devices has created favorable conditions. China\\ s exports of medical equipment industry is in rapid development of the rise.
\"Although the medical equipment market continues to expand exports, but domestic manufacturers of medical equipment products are generally low-tech, export enterprise from the entire composition, foreign investment and joint ventures are still the main force of domestic exports of medical equipment.\" SGS in port Medical Services Director off Junchao said: \"Faced with the continuous expansion of the industrial scale, improve product quality and technological content of products medical equipment export business will be to seize the international market, the key to the medical equipment export enterprises should attach importance to product quality, early understanding of international market access requirements and the specific provisions of national standards, early production and export of the corresponding well prepared to provide guarantees to expand the international market. \"
Shenzhen Wang Bin, Medical Devices Industry Association, said that with the expansion of the medical device market demand, China\\ s medical device industry must also continue to grow. Improve product quality, to enhance the competitiveness of products, will be the challenge for many enterprises. Medical Device Industry Association, Shenzhen will integrate industry, government and community resources, communication and technical support to establish platform for government and enterprise, organization-related training, to enhance the business competitiveness of products in the market to provide technical support to improve the capability of independent innovation and quality management; to help businesses through technical means and means to achieve corporate commitment to quality management, product value and enable enterprises to enhance brand value, improve the Shenzhen company\\ s competitiveness in the international market. In addition, the Shenzhen medical device industry associations will continue to strengthen cooperation with other international renowned certification body SGS close cooperation, providing medical equipment testing and certification products and international market access series of training.
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