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The comparison in medical device regulation in china and us challenges and opportunities

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comparitive analysis between medical device markets and opportunities us usa and china

comparitive analysis between medical device markets and opportunities us usa and china

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  • 1. 1 The Comparison in Medical Device Regulation in China and US Challenges and Opportunities Mingzi Deng
  • 2. 1 Contents 1. Background - Rapidly developing China................................................................1 2. Chinese Medical Device Industry Snapshot ...........................................................2 2.1 The Current Medical Device Market............................................................2 2.2 Forecast and Potential Market......................................................................2 2.3 Where is the medical device industry located? ............................................3 2.4 Where are the medical devices imported from?...........................................4 3. Medical Devices Regulatory Authority in China and US.......................................4 3.1 Medical Devices Regulatory Authority In China.........................................4 3.2 Medical Devices Regulatory Authority In US .............................................5 3.3 The Comparison of SFDA and FDA structure .............................................6 4. The Comparison of Medical Device Definition......................................................7 4.1 The Definition of Medical Device in China.................................................7 4.2 The Definition of Medical Device in US .....................................................8 4.3 The Comparison of Medical Device Definition...........................................9 5. The Comparison of Classifications of the Medical Device ..................................10 5.1 The Classification of Medical Devices in China........................................10 5.2 The Classification of Medical Device in US..............................................10 5.3 The Comparison of Classification of Medical Devices..............................11 6. The Differences of Medical Devices Administration System in China and US ...12
  • 3. 2 6.1 The Legal Status.........................................................................................12 6.2 The Administration Status..........................................................................13 6.3 Opening Information ..................................................................................14 6.4 Dealing With Adverse Events.....................................................................14 7. How to Improve the Chinese Medical Device Registration System.....................15 7.1 Establish and Standardize the Nomenclature of Medical Devices.............15 7.2 Adjustment of the Product Classification...................................................16 7.3 Scientific Clinical Trails for Medical Devices ...........................................16 8. Challenges in Chinese Medical Devices Industry ................................................17 8.1 Standards in different levels are different...................................................17 8.2 Laws and Regulations are Constantly Changing........................................17 8.3 Limited Official Announcement in English ...............................................18 8.4 Much more Complex Relationships between Chinese Industry and Government...........................................................................................................18 9. Opportunities in Chinese Medical Devices Industry ............................................19 10. Conclusion ............................................................................................................19 References....................................................................................................................21
  • 4. 3
  • 5. 1 1. Background - Rapidly developing China China has the largest population in the world, which is estimated at more than 1.3 billion. Since opening the economy to the West in 1978, China’s economy has had an unbelievable growth in these past 30 years. In the last decade, China has kept a rapid GDP (Gross Domestic Product) growth rate at approximately 10%. According to the data from the World Bank (Fig.1), from 2003 to 2008, China keeps a growth rate of GAP over 9%. In 2009, China’s GDP is 4984 billion USD (The World Bank, 2009), and in this year, China’s GDP is estimated to 5738 USD (EBI, 2007). Although the per capita wealth is still low based on the large population, China still is one of several countries which can keep economic growth during the financial crisis. Figure 2 shows the export and import levels in recent years. It is obviously that the trade level quadrupled from 2002 to 2008 (The Word Bank, 2009). Based on its rapid development and huge population, China has the potential to be an important part of the global market, which includes the medical device market. Figure 1 Figure 2
  • 6. 2 2. Chinese Medical Device Industry Snapshot 2.1 The Current Medical Device Market It is obviously that China is a very potential market, so how is the current medical device market going? China is a large market, but how big it is, several reports give us different answers. According to the data from Osec Business Network Switzerland (OBNS), China’s medical device market in 2005 was 6.2 billion USD (OBNS, 2007). Based on the Espicom Business Intelligence (EBI) estimated, it was 13.7 billion USD in 2006, with a 12.9% increasing from the last year (EBI, 2007). It means that EBI estimated the China’s market as 12.1 billion USD, which is doubled as the OBNS’s result. Otherwise, according to the report from the National Development and Reform Commission (NDRC), in 2004, the medical device market size was 6.6 billion USD; in 2005, it was 7.3 billion USD (NDRC, 2005). 2.2 Forecast and Potential Market The three reports mentioned in last part have three different results, because these are all independent research. Generally speaking, the report from NDRC should be more authoritative as a Chinese official report. Although it does not have a unified result, there’s one thing in common – all these report agreed that China is a very potential market. EBI predicted the annual growth rate of the market in the period 2006-2011 is 11.1% (EBI, 2007); NDRC said it keeps a growth rate as 9 percent per year (NDRC, 2005); and according to the data from OBNS, the supply of medical
  • 7. 3 device in Chinese market only met approximately 60 percent of the demand from 2003 to 2005, despite the numbers of manufacturers increased 19% from 356 in 1985 to 10,447 in 2004 (See Figure 3; OBNS, 2007). 2.3 Where is the medical device industry located? As the most populated country in the world, China has several economic developing clusters, which is also related to the regional population. For instance, in 2007, according to the official data, Guangdong province had the largest population as 94.5 million people, equal as 7.2% of the total, and the Pearl River Delta, as one of the famous industry zone in China, is in there. Eastern China, which is the most populated region in the country, inhabits 379.8 million people, and includes the Yangtze River Delta and the Circum-Bohai-Sea Region. The Pearl River delta, Figure 3
  • 8. 4 Yangtze River delta and the Circum-Bohai-Sea Region are the areas where the medical device industry concentrates in. The sales income and output value in these three regions account for over 80% of the national total (EBI, 2007; Report, 2009). 2.4 Where are the medical devices imported from? “In the first half of 2007, the top countries for China's medical device imports remained the United States, Japan and Germany. China imported 580 million USD worth of medical device from the US, an increase of 11.15% over the previous year; 350 million USD from Germany, an increase of 16.33%; and 330 million USD from Japan, a drop of 3.17%. In fact, 65.26% of all China's medical device imports came from these three countries (See Figure 4; China, 2007).” 3. Medical Devices Regulatory Authority in China and US 3.1 Medical Devices Regulatory Authority In China The main medical devices regulatory authorities in China include the State Food and Drug Administration (SFDA), General Administration of Quality Supervision, Inspection and quarantine (AQSIQ), Ministry of Health (MOH) and Department of Commerce (DOC). The SFDA is mainly responsible for the medical devices Figure 4
  • 9. 5 registration and supervision. The AQSIQ’s main responsibility is to supervise the medical devices market, especially the import and export parts. The MOH is in charge of supervising all the hospitals and healthcare centers. The DOC is responsible for the macroeconomic regulation and control, and the policy implement on the medical device industry. There are two departments in SFDA related to the medical device – Department of Medical Devices and the Inspection Bureau. The Department of Medical Devices is responsible for the medical devices research and producing progress. The Inspection Bureau supervises the process of medical devices distribution and using, and punishes the manufacturers who build the unlicensed medical devices. These two departments have their own responsibility, but also cooperate with each other, in order to ensure the safety and effectiveness of the medical devices. There are 5 offices under the Department of Medical Devices – the General Office, the Registration Office I, and II, the Office of surveillance of manufacturing and distribution, and the Office of Device Research and Evaluation. There are 5 offices under the Inspection Bureau – the General Office and the Inspection Office I, II, III and IV. The Inspection Office II is the one who punishes the manufacturers who build the unqualified medical devices (SFDA, 2010). 3.2 Medical Devices Regulatory Authority In US The Food and Drug Administration (FDA) is one of the most respected administrations in the world with a long history in the United States. The FDA
  • 10. 6 compromises several offices and centers. In FDA, Center for Devices and Radiological Health (CDRH) is the medical devices regulatory authority. It includes the Office of the Center Director, the Office of Communication, Education, and Radiation Programs, the Office of Compliance, the Office of Device Evaluation, the Office of in Vitro Diagnostic Device Evaluation and Safety, the Office of Management Operations, the Office of Science and Engineering Laboratories and the Office of Surveillance and Biometrics. There are other important offices in the FDA, which enforces the laws related to medical devices and other products that the FDA regulates, called the Office of Regulatory Affairs (ORA). It is considered the "eyes and ears" of the agency, it includes 5 regional offices and 20 district offices; it is kind of similar as the Investigation Bureau in the SFDA in China (About the CDRH, 2010). 3.3 The Comparison of SFDA and FDA structure Based on the different national status, there is no one-to-one correspondence between the departments in SFDA and FDA, although the main purpose is the same – to protect and promote public health. Therefore, based on the same purpose and the different national status, we can only know which departments have the similar responsibilities. For instance, the Office of Regulatory Affairs (ORA) in FDA has the similar responsibilities as the Department of Commerce (DOC) and part of the Investigation Bureau; the Office of Device Evaluation, the Office of in Vitro Diagnostic Device Evaluation and Safety, the Office of Science and Engineering
  • 11. 7 Laboratories in FDA are similar as the Office of Device Research and Evaluation in SFDA; the Office of Surveillance and Biometrics in FDA is in part similar as the Office of surveillance of manufacturing and distribution in SFDA (See Figure 5). Actually, it might not be suitable to compare these different departments in FDA and SFDA, because the different registration and regulation system, although they have the same purpose. 4. The Comparison of Medical Device Definition 4.1 The Definition of Medical Device in China According to the Regulations for the Supervision and Administration of Medical Devices (Decree of the State Council No. 276) (Regulations, 2000): Any instrument, apparatus, appliance, material, or other article whether used Figure 5
  • 12. 8 alone or in combination, including the software necessary for its proper application. It does not achieve its principal action in or on the human body by means of pharmacology, immunology or metabolism, but which may be assisted in its function by such means; the use of which is to achieve the following intended objectives: 1) Diagnosis, prevention, monitoring, treatment or alleviation of disease; 2) Diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap conditions; 3) Investigation, replacement or modification for anatomy or a physiological process; 4) Control of conception. 4.2 The Definition of Medical Device in US FDA defines a medical device as "an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is: 1) recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them, 2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or 3) intended to affect the structure or any function of the body of man or other animals, and which does not achieve any of its primary intended purposes through chemical action within or on the body of man or other animals and which is not
  • 13. 9 dependent upon being metabolized for the achievement of any of its primary intended purposes (FDA, 2010)." 4.3 The Comparison of Medical Device Definition The definitions of Medical Devices in China and the US are similar, but still have several differences, such as: 1. In China’s definition, it is seeing the medical used software as medical devices, but the US doesn’t. The software does not mention in the definition of medical devices, however, the US FDA has the “General Principles of Software Validation,” and the software validation also administrates by the Center for Devices and Radiological Health (CDRH). Therefore, this is just a descriptive difference. 2. The US emphasizes that the devices are “recognized in the official National Formulary, or the U.S. Pharmacopoeia, or any supplement to them.” The FDA has a database which can check the classification of the medical devices, whereas China has the “Product Classification Catalog of Medical Devices.” 3. The US contains the devices for “the other animals” as medical devices, which China does not. China has a veterinary department the Ministry of Agriculture administrates the veterinary devices. Thus, in China, medical devices related to “the other animals” do not administrate by the SFDA; and in the US, all medical devices administrate by the US FDA. 4. In the China’s definition, the devices related to controlling of conception are
  • 14. 10 medical devices. In the US, there are no such words. Although I reviewed the “Product Classification of Medical Devices,” I cannot find any devices related to the control of conception. 5. The Comparison of Classifications of the Medical Device 5.1 The Classification of Medical Devices in China The classification of medical devices in China divides by three risk levels from low to high (Regulations, 2000). Class I Medical Devices: safety and effectiveness can be ensured through routine administration; Class II Medical Devices: further control is required to ensure their safety and effectiveness; Class III Medical Devices: implanted into the human body, or used for life support or sustenance, or pose potential risks to the human body and thus must be strictly controlled in respect to safety and effectiveness. 5.2 The Classification of Medical Device in US Class I: General Controls Devices for which general controls are sufficient to ensure safety and effectiveness Pose minimal harm to user. Examples: bandages, examination gloves, Class II: Performance Standards and Special controls
  • 15. 11 General controls determined to be insufficient to provide reasonable assurance of safety and effectiveness However, there exists sufficient information to establish performance standard to provide such assurance Higher risk that class I Examples: wheelchairs, infusion pumps, daily wear contact lenses, urological catheter, condoms Class III: Premarket Approval Stringent regulatory class Used for life-sustaining or life-supporting purposes, those implanted in the body and; Those presenting potential unreasonable risks of illness or injury These devices have insufficient information to provide reasonable assurance of safety and effectiveness Examples: overnight wear contact lenses, replacement heart valves, cardiac stents (Part 860, 2010) 5.3 The Comparison of Classification of Medical Devices The US FDA is the one who proposed to classify the medical devices in order to improve the management effectiveness; The European Union and China have followed and modified the pattern. The European Medical Devices Directive (MDD) divides medical device products into 4 levels – I, IIa, IIb and III, as the US and China have 3 levels. The Global Harmonization Task Force (GHTF), which is an unofficial
  • 16. 12 international organization focus on achieving greater uniformity between national medical device regulatory systems, considers the 4 level European classification is more reasonable. The EU classification system is based on the principle of classification; the US is based on the medical devices classification database, with the experts support. Compare with EU and US, China uses the product classification catalog of medical devices, similar as the US classification database, but also use the principle of classification. Briefly, based on its unique status of the medical device market, China learned from US and EU on the medical device classification. Otherwise, the proportion of high-risk level medical devices is different in these three systems. In EU and US, the medical devices divided into level III are much less than the ones in China. Actually, too many products divided into level III will give the manufacturers a heavy burden, and cause the low effectiveness on the governmental administration. 6. The Differences of Medical Devices Administration System in China and US 6.1 The Legal Status In the United States, the medical device related laws were passed by the congress. The current laws related to medical device include “Federal Food, Drug, and Cosmetic Act (FD&CA)”, “Fair Packaging and Labeling Act”, “Medical Device Regulation Act”, “Food and Drug Administration Modernization Act” and “Medical Device User Fee and Modernization Act (MDUFMA).” All these laws were passed by
  • 17. 13 the US congress. The Federal Food, Drug, and Cosmetic Act, as the basic law in medical device regulation, has been modified many times, and has very detailed rules for the specific medical devices, such as the definition on mislabeled or unqualified medical devices. Other countries always use US standard as the reference standards. The China’s “regulations on supervision and management to medical devices” was promulgated by the State Council, so the legal status is not as high as the US FD&CA. The detailed rules in China’s regulation are not so specific, because China does not have so much experience as US does. Otherwise, there are some overlapped responsibilities between the different departments. 6.2 The Administration Status FDA is a federal agency, and it has district offices in more than hundred cities. Compare with the FDA, SFDA has 2 levels, besides the national level, there is a provincial level, which lead the city and country levels below. There are more than hundred city level agencies and thousands country level agencies all over the nation. The FDA model is more appropriate to implement the policies. The administrational level differences are caused by the different political systems. The United States is a federal country; every state has its own autonomous rights. The federal government only controls inter-states and international business. The federal government set the agency like FDA because the medical devices relates to people’s health. It is serious, and need the communication between all the states, so the states do not need to have their own state-level FDA, all in charge by FDA.
  • 18. 14 Compare with the US, China is a centralized country, the city level agencies lead by the provincial level and national level agencies at the same time. China built the surveillance and communication network from nation level to city level, in order to enhance the management of medical devices. 6.3 Opening Information FDA is one of the most respected administrations in the US legal system, although it has been doubted in recent years. According to the official survey, the approval rate of FDA is higher than the federal government. Even after the Vioxx event, the FDA planed to have some innovation. The way FDA can get support from public is the scientific decision-making, information opening and propagandizing widely. FDA not only has the experts to evaluate the advanced medical devices, but also prefers to get feedback from the public and make improvement. This is the way FDA keeps a good relationship with the public. Compare with FDA, SFDA emphasizes the pre-market approval and supervision. All the medical devices need to get the pre-market approval, and the manufacturer who produce level II and III medical devices also need the certification. The transfer to pay more attention on post-marketing supervision will spend a long time for SFDA. 6.4 Dealing With Adverse Events FDA and SFA have different ways on dealing with adverse events. If the FDA meets such problems, their main actions will be correction and punishment. The FDA
  • 19. 15 encourages the manufacturers recalling the products, and sometimes the problem can be solved by improve the product or correct the management on-site. Otherwise, the FDA will release the warning letter to the public or the manufacturer. If the manufacturer does not do anything, the FDA will enforce the punishment. SFDA has the similar punishment policy as FDA, but it is has more freedom. In China’s medical device regulation, there is specific punishment for the slightest illegal act, and there is no policy about recalling and releasing a warning letter. 7. How to Improve the Chinese Medical Device Registration System. 7.1 Establish and Standardize the Nomenclature of Medical Devices The naming of medical devices is a scientific nomenclature which should be simple, practical, scientific and standard. The uniform of the medical device products’ name is directly connected with the uniform of medical devices market. All the non-standard names, deceptive name and the name departure the legal advertising regulations should be removed or corrected. Government should build a completed system to standard the requirements of medical devices marketing, the testing methods, and the guidelines for technical reviewing. US FDA has already established a detailed naming system of medical devices. It can also be used in China. But the most important thing now is to establish the nomenclature for medical devices. In general, the name of medical devices is very important as the basic theory and combined with functional objects, producing purpose, forms and other elements.
  • 20. 16 Standard name of medical devices should be regularly edited and announced in public, then supervised by people and market. 7.2 Adjustment of the Product Classification. The current category version of medical devices classification in China is too old with unclear and unscientific standards. Different class of medical devices should have different principles and different requirements followed with the general control, special control and high-risk control. Senior scientists reviewing or auditing review is necessary when it is unsure how to make a product name. Classification should not proved only by a report from manufacturer or a governor. Only the relevant departments of State Council on the substantive reviewing and products evaluation can give the correct name. 7.3 Scientific Clinical Trails for Medical Devices In Chinese pharmaceutical industry, not all the medical devices need to do the clinical trail, some of which need to do the clinical trail even investigation after being published, some of which only need to do the results comparison testing with another similar functional equipment if the medical device is under a low management risk. Different situation should be treated different. Building the technical guidelines for different types of medical devices, different type of clinical trails and clinical validations is the first important thing to do on current situation to make clear requirements. The guideline should be built under the
  • 21. 17 control of government administration. 8. Challenges in Chinese Medical Devices Industry 8.1 Standards in different levels are different In China, manufacturing and management standards always changed with the development of technology, which makes a big challenge for companies and agents. An application or manufacturing procedure used in one product can never be used in another product. Governmental document said that “changes occur to the national standards or industry standards for which the product standards are adopted, medical devices which had received registration approval…should approved according to original standards…however, the medical device should be manufactured according to the new version”. It is unclear here that which version of standard we should follow, the national standard, the industry standard or the product standard? And which should be the original standard? Those confusing information also happened frequently in all the related standards. 8.2 Laws and Regulations are Constantly Changing Not only the standards, but also the laws and regulations are constantly changing. Take the State Council Order 276 for example. Order 276 is regulation for the supervision and administration of medical devices, governing China’s health sector. It is enacted in April 1st, 2000 and has been amended on several occasions by “red letters”, which is given legal effect. But until Sep. 6, 2010, Order 276 has been
  • 22. 18 amended 6 times, expanded from 6 chapters, 48 articles to 9 chapters, 88 articles. 8.3 Limited Official Announcement in English The SFDA website is using simple Chinese as the official language which is hard for foreign companies to understand and follow. Chinese government updates latest domestic news about the safety of food and drug, also the policies and rules frequently through the State Food and Drug Administration on its website. But all the information is written in Chinese. The English translated website of SFDA does not include all the information from the original webpage and only updated monthly with few news and regulation guidelines. Some translations of regulations provides in “Chinglish” which means “Chinese English”. “Chinglish” can annoy readers, and embarrass non-native English speakers and always make them misunderstand the real meaning of Chinese regulations and policies. 8.4 Much more Complex Relationships between Chinese Industry and Government With the development of thousands of years, relationship becomes very important in Chinese culture. The same in health industry, all the business man in medical device field have to learn the relationship between human beings, the relationship between government and industry, the relationship between consumers and producers. The manufacturer has to be aware of consumers’ needs and will take them into account when deciding the course of the future actions which concern or
  • 23. 19 could concern themselves without any specific discussion or request. The manufacturer should also consider about how to build a good relationship with government and public, which is a big challenge for those who are not really familiar with Chinese culture and custom. 9. Opportunities in Chinese Medical Devices Industry April 6, 2009. Chinese government announced a new reform scheme on medical and health system. About RMB 850 billion (about 127 billion dollars) will be invested through 2009- 2011 to promote medical and health system reform, which is a good news for both domestic and international medical device manufacturers. Expert in related field estimated that at least RMB 16 billion will be used in Medical Device investment. This is a big opportunity for those competitive companies which want to expand capital in international market to fight for the benefits from this reform. For those developed countries, they have competitive advantages to develop the most advanced technologies or import new products to Chinese market. In China, they don’t have any domestic medical device companies with the capital of more than 5 hundred billion dollars. The only few competitive companies are those international Joint-stock cooperative enterprises or international investment company. But in the world, it has more than 300 hundred companies in health field with the capital of more than 5 hundred billion dollars. America takes 170 of them. 10. Conclusion
  • 24. 20 After comparing the medical device regulation difference in US and China and analyzing the challenges in Chinese industry, we can find out that Chinese government has paid more attention to promote the development of medical device industry. With the improvement of related polices and regulations, Chinese will become a large market to provide more opportunities to medical device manufacturers and perfect its health system.
  • 25. 21 References About the Center for Devices and Radiological Health. FDA. http://www.fda.gov/AboutFDA/CentersOffices/CDRH/default.htm. Accessed by Nov 23, 2010. China Medical Devices Research Report. 2007. http://www.ucbcgroup.org/News/..%5CFileFolder%5CUCBC%20Sep08%20New sletter.pdf. Access by Nov 23, 2010. Espicom Business Intelligence (EBI). The Chinese medical device market: Facts and figures. China: Accessing the Medical Device Market. July 2007 http://www.tmta.ca/attachments/Medical%20Devices%20in%20China.pdf. Access by Nov 23, 2010. http://www.espicom.com/prodcat2.nsf/Product_ID_Lookup/00000541?OpenDoc ument. Access by Nov 23, 2010. FDA. Is The Product A Medical Device? http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Overview/C lassifyYourDevice/ucm051512.htm. Accessed by Nov 23, 2010. National Development and Reform Commission (NDRC). The Research Proposal of Chinese Medical Device Market and Price evaluation. 2005. http://www.sdpc.gov.cn/yjzq/W020060711533235210478.doc. Accessed by Nov 23, 2010.
  • 26. 22 Osec Business Network Switzerland (OBNS). Market Report: Medical Device Market in China 2007. http://www.osec.ch/internet/osec/de/home/export/publications/free.-ContentSlot-3139 1-ItemList-67490-File.File.pdf/BB_Marktstudie_Medical_Device_Market_in_China_ 070215.pdf. Access by Nov 23, 2010. Part 860. Code of Federal Regulations Title 21 (21CFR). FDA. http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm?CFRP art=860. Accessed by Nov 23, 2010. Regulations for the Supervision and Administration of Medical Devices. State Food and Drug Administration (SFDA). P.R.China. Jan 4, 2000. http://eng.sfda.gov.cn/cmsweb/webportal/W45649038/A48335998.html. Access by Nov 23, 2010. Report on China's medical device market and investment. The Medical News. Sep 8, 2009 http://www.news-medical.net/news/20090908/Report-on-Chinas-medical-device- market-and-investment.aspx?page=2. Access by Nov 23, 2010. State Food and Drug Administration (SFDA). 医疗器械监督司. http://www.sfda.gov.cn/WS01/CL0187/ . Accessed by Nov 23, 2010. The World Bank. 2009. http://data.worldbank.org/country/china. Accessed by Nov 23, 2010.

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