Tags: | NMPA | Medical Device | Medical Device | 药监局 | 医疗器械 | 医疗器械 |

Statistics from the Ministry of Health show that in 2008, China had healthcare expenditures of more than 10,00 billion Yuan, representing 5.5% of its GDP, compared to average 8% to 10% of GDP for the developed countries in Europe and the Americas. For the United States, the percentage of GDP is even representing up to 15.5%. In accordance with an average annual growth rate of more than 10% of China's healthcare market in the first 10 years of this century, expected by 2020, China will surpass the U.S to become the world's second largest healthcare market.

Meanwhile, the Chinese Government vigorously promotes China's health-care reform. In April 2009, "Approval on deepening the Reform of Health-care System" and "Guidelines on Deepening the Reform of Health-care System after about three years from 2009 to 2011", jointly endorsed by the Central Committee of the Communist Party of China and the State Council, are officially published for implementation. So far, China unveiled a blueprint for health-care over the next decade, kicking off a much-anticipated reform to fix the ailing medical system and to ensure fair and affordable health services for all 1.3 billion citizens. The new health-care reform pointed out:

(a) An investment plan of 850 billion Yuan (124 billion U.S. dollars) for the reform is planed to inject by Chinese government in three years until 2011, equal to 280 billion Yuan per year. Health Minister Chen Zhu explained while answering a Xinhua reporter: "the next three years, the Government can invest 280 billion Yuan per year. It is enhanced, which is based on the original. For example, last year nearly 240 billion Yuan invested by the government, plus 280 billion Yuan, is to be more than 500 billion Yuan per year. "

These investments are mainly to be used for basic medical insurance, the essential drugs of medical system, medical services, public health and the reform of public hospitals. All these reforms will enable China to achieve the transformation of China's medical system and the concept from "concentration on treatment" to "prevention". And it enormously boosts the development of the medical device industry which is the important measure for the diagnosis and treatment.

(b) The ratio of urban and rural residents covered by the basic medical insurance is expected to surpass 90 percent by 2011. Calculated with a population of approximately 1.33 billion in 2008 according to the statistics from World Bank, by 2011 China's health-care system will cover about 1.2 billion people.

Medical Devices, as modern science and technology products, have been widely used in the process of disease prevention, diagnosis, treatment, care and rehabilitation, and become an important means of modern medicine for diagnosis and treatment. This viewpoint has been widely recognized in China and followed up with the medical principle of respecting the evidence. Moreover, in order to meet the health needs of Great Medical Care, in 2008 the Chinese government reorganized the State Food and Drug Administration (SFDA), the highest administration authority in charge of medical devices and IVD, into the Chinese Ministry of Health (MOH), the administration authority in charge of the entire medical and healthcare.

Currently, although there is still a wide gap between China's medical devices industry and that in the developed countries, China's MD market has maintained a relatively rapid pace of the development. Since 2001, China's medical devices industry has made rapid progress and the annual growing rate has reached 15% ~ 20%. In 2008, the gross output value of medical devices reached 300 billion Yuan. Affected by the global financial crisis, the mainstream international medical device market tends to shrink, while China's medical device industry has a huge space for development 850 under the influence of 850 billion yuan (124 billion U.S. dollars) investment for China's Health-care Reform. It is estimated that within the next few years, China's medical devices market is likely to be more than 600 billion Yuan, or surpass Japan to become the world's second largest medical devices market just after the United States.