latest chinese guidebook for application and approval of imported medical device registration: from...

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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)




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.




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.




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.




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.




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.




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.




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 DevicesFor more details regarding Report coverage see the last slide





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





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






Company Coverage:

1. GE

2. Siemens

3. Philips






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latest chinese guidebook for application and approval of imported medical device registration: from...

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