Market Research Reports, Inc. has announced the addition of “Latest Chinese Guidebook for Application and Approval of Imported Medical Device Registration: From Regulations to Practices (2014 Edition)” research report to their offering. See more at- http://mrr.cm/ZXS

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Category : Pharma & Healthcare
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Introduction to Report
 Launch Date: August 25, 2014
 Number of Pages: 194
 Geography Coverage: China
 Available Format: PDF
Price For Single User License: USD 1,250
Price For Site User License: USD 4,125
Price For Global User License: USD 7,000
Delivery Time: Within 24 Hours (During Working
Days)

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About the Report
This report 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.
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.

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Key Findings:
Chinese state council issued the latest
“Regulations for the Supervision and
Administration of Medical Devices to try to
completely change such imperfect status.
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.
The overseas and multinational medical device
manufacturers must have a comprehensive and
thorough knowledge of the latest Chinese
regulations on medical device registration.

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Key Findings Continues…
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.
After having skimmed through this guidebook,
audiences can clearly acquire not only a
comprehensive and thorough knowledge of the
latest Chinese regulations on imported medical
device registration but also the practical operation
how to comply with the latest Chinese regulations.

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Report Highlights :
An overview of the latest Chinese applicable
regulations for imported overseas medical device
registration and recordation.
What the Chinese regulations on medical devices are
undergoing earthshaking changes?
An overview of organizational structure of Chinese
regulatory authorities for imported medical device
registration and recordation to give the direction of
gateway for imported medical device registration and
recordation.
The knowledge preparation before application of
imported overseas medical device registration and
recordation to let overseas medical device manufacturer
understand the unique Chinese approach for medical
device registration and lay the knowledge foundation
for the practical operation.

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Report Highlights Continues…
The lates Chinese regulations for application for
imported medical device recordation, which is
applicable to Class I imported overseas medical
devices.
The lates Chinese regulations for application and
approval for imported medical device registration,
which is applicable to Class II and II imported overseas
medical devices.
The detailed Chinese medical device classification.
The rights of human subjects and every party’s
responsibilities in clinical trials for imported overseas
medical devices in China.
The practical guidance for alteration registration and
renewal registration of imported overseas medical
devices, also from how to compile application
documents to how to submit application documents
step by step.

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Report Highlights Continues…
The practical guidance for application and approval of
imported overseas medical device registration, also
from how to compile application documents, how to
conduct clinical trials for imported overseas medical
devices to the application for approval of imported
overseas medical device registration to smoothly
navigate complex regulatory requirements step by step.

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Report Coverage
1. Executive Summary
2. Analysis and Research for Radical Change of
Chinese Regulations on Medical Devices
3. Chinese Applicable Regulations for Medical
Device Registration
4. An Overview of Chinese Regulatory Authorities
for Imported Medical Device Registration
5. Knowledge Preparation before Application of
Imported Medical Device Registration
6. Medical Device Classification
7. Rights of Human Subjects and Every Party's
Responsibilities in Clinical Trials for Imported
Medical Devices
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Report Coverage Continues…
8. Application for Imported Medical Device
Recordation
9. Application and Approval for Imported Medical
Device Registration
10. Application and Approval for Alteration
Registration of Imported Medical Devices
11. Application and Approval for Renewal
Registration of Imported Medical Devices
12. Supervision and Administration for Application
and Approval of Imported Medical Device
Registration
13. Practical Guidance for Application of Imported
Medical Device Recordation
For more details regarding Report coverage see the last slide
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Report Coverage Continues…
14. Practical Guidance for Application and
Approval of Imported Medical Device
Registration
15. Practical Guidance for Alteration Registration
and Renewal Registration of Imported Medical
Devices
16. Appendices
17. Appendix
For more details regarding Report coverage see the last slide
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Company Coverage:
1. GE
2. Siemens
3. Philips
For more details regarding Report coverage see the last slide
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How To Buy This Report?
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purchase this publication:
http://mrr.cm/ZXS
About Market Research Reports, Inc.
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