Synopsis
China’s
regulatory framework for medical devices is undergoing radical changes. The
country’s new leaders have recognized that the regulations for supervision and
administration of medical devices are far from perfect along with rapid
population growth and thriving economy over the past 30 years. Chinese state
council issued the latest “Regulations for the Supervision and Administration
of Medical Devices” on February 12, 2014, which has come into force as of June
1, 2014. Before long, China Food and Drug Administration (hereafter called as
CFDA) issued the latest “Measures for the Administration of Medical Device
Registration”, which has come into force as of October 1, 2014.The overseas
medical devices exporting into China market are subject to administration of
overall new regulations on medical device registration since October 1, 2014.
The
Chinese concept of clinical evaluation and clinical trial for medical device
registration is unique, which is distinct from the clinical trial in U.S. and
EU countries. How do you in compliance with the latest Chinese regulations on
medical devices? How do you operate business smoothly in China? How do you
conduct the clinical evaluation and clinical trial for your products exporting
into the Chinese market?
Browse Full Report With TOC @ http://www.radiantinsights.com/research/latest-guidebook-for-conducting-medical-device-clinical-evaluation-and-clinical-trial-in-china-%20from-regulations-to-practices
To
enter such a lucrative medical device market, overseas and multinational
medical device manufacturers must have a comprehensive and thorough knowledge
of the latest Chinese regulations on medical device clinical evaluation and
clinical trial. Otherwise, the restrictive legal requirements and approval
delays eat up your development time and budget.
Latest
Guidebook for Conducting Medical Device Clinical Evaluation and Clinical Trial
in China: From Regulations to Practices
not only provided a comprehensive and thorough knowledge of the latest
Chinese regulations on clinical evaluation and clinical trial for imported
medical device registration but also introduced the practical operation how to
comply with the Chinese GCP to guide you use the Chinese trial venues to keep
medical device development lean and achieve a successful approval for your
products entry into the Chinese medical device market.
Related reports by Radiant Insights: http://www.radiantinsights.com/catalog/medical-devices
Summary
China’s
regulatory framework for medical devices is undergoing radical changes. The
country’s new leaders have recognized that the regulations for supervision and
administration of medical devices are far from perfect along with rapid
population growth and thriving economy over the past 30 years. Chinese state
council issued the latest “Regulations for the Supervision and Administration
of Medical Devices” on February 12, 2014, which has come into force as of June
1, 2014. Before long, China Food and Drug Administration (hereafter called as
CFDA) issued the latest “Measures for the Administration of Medical Device
Registration”, which has come into force as of October 1, 2014.The overseas
medical devices exporting into China market are subject to administration of
overall new regulations on medical device registration since October 1, 2014.
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Italy Respiratory Devices Market Outlook to 2021 - http://www.radiantinsights.com/research/italy-respiratory-devices-market-outlook-to-2021
In
2009, the Chinese government vigorously launched “China’s Health-Care Reform”,
developed an ambitious blueprint, in which health care system covered about 1.2
billion people by 2011. 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 (about 29 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 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 (about 57
billion US dollars) by 2015, and will surpass Japan to become the second
largest medical device market behind the United States. The Chinese medical
device market is one of segment market of the most growth potentiality, which
is attracting more and more overseas medical device manufacturers and producers
to penetrate such market.
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