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 2014, total value of medical devices on Chinese healthcare market has reached 255.6 billion RMB (about 40.25 billion US dollars). 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 (MRI) equipments, computed tomography (CT) equipments are almost monopolized by GE, Siemens, Philips and other overseas and multinational companies.
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It is estimated that Chinese medical device market will be likely to be more than 340 billion RMB (about 53.15 billion US dollars) by 2015, and will surpass Japan to become the second largest medical device market behind the United States. Undoubtedly, China has an indispensable medical device market for overseas and multinational medical device companies. It’s definitely a field worth playing on.
However, since October 2014, Chinese regulatory authorities have significantly changed the regulations on medical devices. China Food and Drug Administration (CFDA) issued the latest Chinese Good Manufacturing Practice (GMP) Regulations for Medical Devices on December 29, 2014, which has come into force as March 1, 2015.
On July 10, 2015, China Food and Drug Administration (CFDA) further issued the latest Implementation Regulations of Good Manufacturing Practice (GMP) for Sterile Medical Devices, Implementation Regulations of Good Manufacturing Practice (GMP) for Implantable Medical Devices as the appendices of the latest Chinese Good Manufacturing Practice (GMP) Regulations for Medical Devices respectively.
They have come into force as October 1, 2015. Furthermore, on September 25, 2015, China Food and Drug Administration (CFDA) issued the latest On-site Inspection Guideline of Good Manufacturing Practice (GMP) for Medical Devices, On-site Inspection Guideline for Sterile Medical Device GMP Implementation Regulations, and On-site Inspection Guideline for Implantable Medical Device GMP Implementation Regulations. Everything changed.
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