Summary
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.
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.
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,
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CT
are 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 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. Moreover, 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.
Latest
Guidebook for Chinese Medical Device Recall Regulations is an essential
resource for overseas and multinational medical device manufacturers and
producers to handle a medical device recall smoothly in China, which provides a
detailed guidance of comprehensive and thorough knowledge of the Chinese
medical device recall regulations.
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Report Highlights
An
overview of organizational structure of Chinese Regulatory Authorities for Medical
Device Recall.
Chinese
general regulations for medical device recall, which cover the definitions
relating to medical device recall, the
answers of who, where and how to submit medical device recall report, the
investigation and evaluation of medical device defects, as well as the
classification for medical device recall.
Detailed
Chinese regulations for voluntary recall of medical devices, from the time
limits of notifying, the indispensable content of the recall notification and
the investigation and evaluation report, the recall plan, the periodically
reporting and summary report to termination of recall.
An
entire process of voluntary recall of medical devices to guide you to
successfully navigate complex regulatory requirements step by step.
Detailed
Chinese regulations for mandatory recall of medical device, tell you how would
trigger a mandatory recall of medical device, how the medical device
manufacturer copes with a mandatory recall of medical device, and how to handle
a mandatory recall of medical device smoothly in China.
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An
entire process of mandatory recall of medical device to guide you to smoothly
navigate complex regulatory requirements step by step.
A
case study of recall of imported medical device from a U.S. company to expose
practical operation.
A
full set of the English and Chinese bilingual forms relating to medical device
recall.
After
have skimmed through this guidebook, audiences can clearly acquire a
comprehensive and thorough knowledge of the latest Chinese Medical Device Recall
Regulations.
Scope
Latest
Guidebook for Chinese Medical Device Recall Regulations is an essential
resource for overseas and multinational medical device manufacturers and
producers to handle a medical device recall smoothly in China, which provides a
detailed guidance of comprehensive and thorough knowledge of the Chinese
medical device recall regulations.
An
overview of organizational structure of Chinese Regulatory Authorities for
Medical Device Recall.
Chinese
general regulations for medical device recall, which cover the definitions
relating to medical device recall, the
answers of who, where and how to submit medical device recall report, the
investigation and evaluation of medical device defects, as well as the
classification for medical device recall.
Detailed
Chinese regulations for voluntary recall of medical devices, from the time
limits of notifying, the indispensable content of the recall notification and
the investigation and evaluation report, the recall plan, the periodically
reporting and summary report to termination of recall.
An
entire process of voluntary recall of medical devices to guide you to
successfully navigate complex regulatory requirements step by step.
Detailed
Chinese regulations for mandatory recall of medical device, tell you how would
trigger a mandatory recall of medical device, how the medical device
manufacturer copes with a mandatory recall of medical device, and how to handle
a mandatory recall of medical device smoothly in China.
An
entire process of mandatory recall of medical device to guide you to smoothly
navigate complex regulatory requirements step by step.
A
case study of recall of imported medical device from a U.S. company to expose
practical operation.
A
full set of the English and Chinese bilingual forms relating to medical device
recall.
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