Medical Device Market Recall Regulations in China- Comprehensive and Thorough Guidebook (2014 Edition)

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Latest guidebook for Chinese Medical Device
Recall Regulations (2014 Edition)
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, 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.
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Latest guidebook for Chinese Medical Device
Recall Regulations (2014 Edition)
Medical devices have been widely used in the
process of disease prevention, diagnosis,
therapy, care and rehabilitation. 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 following the United
States. The Chinese medical device market will
attract more and more overseas medical device
manufacturers and producers to penetrate such
market.
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Latest guidebook for Chinese Medical Device
Recall Regulations (2014 Edition)
If you search on website of the Chinese
regulatory authority of medical devices, China
Food and Drug Administration, you may find there
are many announcements of medical devices recall
for those that made by overseas and multinational
medical device manufacturers, because the
imported medical devices account for about a half
of Chinese medical device market, in which the
high-tech and high-value medical devices, such as
magnetic resonance imaging, CT are
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Latest guidebook for Chinese Medical Device
Recall Regulations (2014 Edition)
almost monopolized by GE, Siemens, Philips and
other overseas and multinational companies. How
to handle a medical device recall smoothly in
China? When is recall reporting voluntary vs.
mandatory? What characteristics of the recall
must you consider when making that determination?
How to comply with Chinese medical device recall
regulations? The overseas and multinational
medical device manufacturers and their senior
executive officers engaging in regulatory affairs
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Latest guidebook for Chinese Medical Device
Recall Regulations (2014 Edition)
need a comprehensive and thorough knowledge of
the Chinese regulations for medical device
recall. Otherwise the overseas and multinational
medical device manufacturers and their imported
medical devices will lose a lucrative medical
device market. The regulations on medical device
recall between China and US-EU are different.
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om/311667.html .