Synopsis
Now,
Chinese regulations on medical devices are undergoing earthshaking changes.
Latest Chinese Guidebook for Application and Approval of Imported Medical
Device Registration：From Regulations to Practices not only provided a comprehensive and
thorough knowledge of the latest Chinese regulations for imported medical
device registration but also introduced the practical operation how to comply
with the Chinese regulations to guide you achieve a successful approval for
your products entry into the Chinese medical device market.
Summary
Now,
Chinese regulations on medical devices are undergoing earthshaking changes.
China’s new leaders have recognized that the regulations for supervision and
administration of medical devices are far from perfect along with rapid
economic and population growth over the pasted three decades. Chinese state
council issued the latest “Regulations for the Supervision and Administration
of Medical Devices” to try to completely
change such imperfect status.
View summary of this report @ http://www.radiantinsights.com/research/latest-chinese-guidebook-for-application-and-approval-of-imported-medical-device-registration-from-regulations-to-practices
China
Food and Drug Administration issued the latest “Measures for the Administration
of Medical Device Registration”, “Regulations on the Administration of the
Instructions and Labels of Medical Devices”, “Measures for the Supervision and
Administration of Medical Device Production”, “Measures for the Supervision and
Administration of Medical Device Distribution” and “Measures for the
Administration of IVD registration” on July 30, 2014 respectively, and they
will come into force as October 1, 2014. The radical change of regulations on
medical devices, especially for the latest “Measures for the Administration of
Medical Device Registration” will bring overseas and multinational medical
device manufacturers the maximum challenges and opportunities.
Read Sample report of this
Category: http://www.radiantinsights.com/catalog/healthcare
Those
medical devices have not been granted the certificate of marketing
authorization of medical device issued by the government authorities of the
country or region of origin will be intercepted outside the door of Chinese
medical device market. How do you in compliance with the latest Chinese
regulations on medical devices? How do you operate business smoothly in China?
How to seize a bigger Chinese medical device market? The overseas and
multinational medical device manufacturers must have a comprehensive and
thorough knowledge of the latest Chinese regulations on medical device
registration. Otherwise, the restrictive legal requirements and approval delays
eat up your time and energy to achieve a successful entry into such a lucrative
medical device market, and cause trouble for your business smoothly in China.
Latest
Chinese Guidebook for Application and Approval of Imported Medical Device
Registration: From Regulations to Practices
not only provided a comprehensive and thorough knowledge of the latest
Chinese regulations for imported medical device registration but also
introduced the practical operation how to comply with the Chinese regulations
to guide you achieve a successful approval for your products entry into the
Chinese medical device market.
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by Radiant Insights:
·
China Regional Anesthesia Disposables Market Outlook
to 2021 - http://www.radiantinsights.com/research/china-regional-anesthesia-disposables-market-outlook-to-2021
·
China Respiratory Devices Market Outlook to 2021 - http://www.radiantinsights.com/research/china-respiratory-devices-market-outlook-to-2021
The
organizations of this guidebook are arranged as follows. Chapter 2 provides the
analysis and research for radical change of Chinese regulations on medical
devices. Chapter 3 introduces the framework of the latest applicable Chinese
regulations for medical device registration to provide a comprehensive and
thorough knowledge of the latest Chinese regulations for medical device
registration. Chapter 4 provides an overview of the Chinese regulatory
authorities -- China Food and Drug Administration (CFDA) being responsible for
application and approval for imported overseas medical device registration and
recordation to give the direction of gateway for imported overseas medical
devices registration and recordation. Chapter 5 elaborates the knowledge
preparation before application of imported overseas medical device registration
to let overseas medical device manufacturer understand the unique Chinese
approach for medical device registration and lay the knowledge foundation for
the practical operation. Chapter 6 elaborates the medical device classification
to let overseas medical device manufacturer understand the Chinese medical device
classification, because the imported overseas medical device registration must
be in compliance with such classification of medical devices. Chapter 7
introduces the rights of human subjects and every party’s responsibilities in
clinical trials for imported overseas medical devices in China. Chapter 8
introduces the regulations for application for imported medical device
recordation, which is applicable to Class I imported overseas medical devices.
Chapter 9 provides the regulations for application and approval for imported
medical device registration, which is applicable to Class II and II imported
overseas medical devices.
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