Synopsis
Chinese
regulatory authorities ---- China Food and Drug Administration unprecedentedly
set a special examination and approval procedures for innovative medical
devices since March 1, 2014, which provides a opportunity to speed up overseas
innovative medical devices entry into Chinese market, and reduce risk from the
registration examination uncertainty and approval delays to eat up your time
and energy. Chinese Special Examination and Approval Procedures for Innovative
Medical Devices: speed up overseas innovative medical devices entry into
Chinese market provided a comprehensive and thorough knowledge of the latest
Chinese special examination and approval procedures for innovative medical
devices to guide your practical operation how to comply with the Chinese
regulations.
Summary
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.
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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.
Download sample Copy of This Report at: http://www.radiantinsights.com/research/chinese-special-examination-and-approval-procedures-for-innovative-medical-devices-speed-up-overseas-innovative-medical-devices-entry-into-chinese-market#tabs-4
Chinese
regulatory authorities ---- China Food and Drug Administration unprecedentedly
set a special examination and approval procedures for innovative medical
devices since March 1, 2014, which provides a opportunity to speed up overseas
innovative medical devices entry into Chinese market, and reduce risk from the
registration examination uncertainty and approval delays to eat up your time
and energy. Chinese Special Examination and Approval Procedures for Innovative
Medical Devices: speed up overseas innovative medical devices entry into
Chinese market provided a comprehensive and thorough knowledge of the latest
Chinese special examination and approval procedures for innovative medical
devices to guide your practical operation how to comply with the Chinese
regulations.
The
organizations of this guidebook are arranged as follows. Chapter 2 introduces
what innovative medical devices are applicable to Chinese special examination
and approval procedures. Chapter 3 introduces who are the Chinese regulatory
authorities for special examination and approval of overseas innovative medical
devices. Chapter 4 elaborates the special regulations for overseas applicant.
Chapter 5 introduces how many application dossiers for an oversea innovative
medical device should be prepared. Chapter 6 provides the practical guidance
for application of special examination and approval of overseas innovative
medical devices. Chapter 7 elaborates the benefits from special examination and
approval of innovative medical devices: process priority and interactive
mechanism. Chapter 8 conclusion gives significant suggestions for overseas and
multinational medical device manufacturers to acquire the qualifications of
special examination and approval for overseas innovative medical devices.
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The
audiences of this guidebook are overseas medical device manufacturers wishing
to enter into the Chinese medical device market, and multinational medical
device companies have penetrated into the Chinese medical device market, and
their senior executive officers engaging in regulatory affairs expecting to
understand how to apply for registration of their medical device products in
China, how to comply with the latest Chinese regulations for medical device registration.
After
having skimmed through this guidebook, audiences can clearly acquire not only a
comprehensive and thorough knowledge of the latest Chinese special examination
and approval of overseas innovative medical devices but also the practical operation
how to comply with the latest Chinese special examination and approval of
overseas innovative medical devices. Access China Management Consulting Ltd
hopes this guidebook, based on full and accurate regulations, can guide
overseas and multinational medical device manufacturers and producers to
achieve a successful entry into the Chinese medical device market, and smoothly
operate their products in China.
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