Total Value of Medical Devices on Chinese Healthcare Market has Reached 179 Billion RMB By 2013

Date: 2015-09-29

Now, China’s regulatory framework for medical devices is undergoing radical changes. China is one of the fastest growing global economies with a fifth population in the world, and is one of the largest healthcare markets around the world. Along with sustained economic and population growth as well as an ageing population, Chinese healthcare market has maintained annually average growth rate above 16 % since 1990s. Among them, medical devices represented dynamical growth since 2000s. By 2013, total value of medical devices on Chinese healthcare market has reached 179 billion RMB. Medical devices have been widely used in the process of disease prevention, diagnosis, therapy, care and rehabilitation. On the Chinese medical device market, imported overseas medical devices made by overseas and multinational medical device manufacturers account for about a half, in which the high-tech and high-valued medical devices, such as magnetic resonance imaging, CT are almost monopolized by GE, Siemens, Philips and other overseas and multinational companies. It is estimated that Chinese medical device market will be likely to be more than 340 billion RMB by 2015, and will surpass Japan to become the second largest medical device market behind the United States.

The Chinese medical device market is attracting more and more overseas medical device manufacturers and producers to penetrate such market.
However, In China, the process of application and approval for imported overseas medical device registration is very complex, because the Chinese medical device authorities administer and control this process by exorbitant administrative regulations and measures. Moreover, these exorbitant administrative measures and regulations are variable and lack of transparency. In addition, the cultural difference between China and Western countries as well as the language barriers will increase the challenge faced by overseas and multinational medical device manufacturers and producers.

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