Executive Summary

Executive SummaryExecutive Summary
China is one of the fastest growing global economies with one fifth population in the world. Nowadays Randy Gregory Jersey , China has become the worlds second largest healthcare market after the United States. Along with sustained economic and
population growth, and rapid population aging, the Chinese healthcare market has
maintained annual compound growth rate above 16 % since 2010s. The statistical
data showed that scale of the Chinese healthcare market has reached RMB 6464.1
billion (about equivalent to US$973.5 billion) by 2017. Among them, the total
value of medical device sales was RMB 663.2 billion (US$95.2 billion) with
annual compound growth rate of 20.27% by 2017. Medical devices have been widely
used in the process of disease prevention Rico Gathers Jersey , diagnosis, therapy, care and rehabilitation.
However, large and medium-sized medical devices Charles Tapper Jersey , high-end medical equipments and high-value medical materials are mainly relying on imported, such as the high-tech and high-valued
imaging systems and navigation and positioning systems. Facing a gigantic
 ese
healthcare market and seize a larger part of Chinese healthcare
market Mike White Jersey , how do the foreign medical device manufacturers in compliance with the latest Chinese regulations on medical devices? How do the
overseas medical device manufacturers operate business smoothly in China? Most
importantly, overseas and multinational medical device manufacturers should
always stand ready to respond to further regulation and policy changes occurred
in China.

The overseas and multinational medical device manufacturers and their senior executive officers engaging in  ese
regulatory authorities.
Chapter 6 expounds the medical device distributors??and medical device user facilities??duties and obligations, which
is important for the distributors within the territory of China of the overseas
and multinational manufacturers of imported medical devices, because they must
also fulfill their duties and obligations that are stipulated by the Chinese
regulatory authorities.
Chapter 7 elaborates the medical device adverse event reporting and evaluation Michael Gallup Jersey , from the basic requirements, the different types of medical device adverse event reporting, and the time limitations for different
types of medical device adverse event reporting to an entire process of medical
device adverse event reporting, which is important for the overseas and
multinational manufacturers of imported medical devices and the agents within
the territory of China designated by the overseas medical device
manufacturers Chaz Green Cowboys Jersey , because they must be in compliance with these regulations.
Chapter 8 introduces how Chinese regulatory authorities implement the key monitoring on certain medical devices.
Chapter 9 elaborates that the marketing authorization holders should adopt what risk
control measures under what circumstances and report to the drug regulatory
authorities.
Chapter 10 elaborates that the marketing authorization holders should proactively conduct the re-evaluation under what circumstances and report
to the drug regulatory authorities.
Chapter 11 introduces that the Chinese regulatory authorities will carry out the focusing inspections on the marketing
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