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Chinese Special Examination and Approval Procedures for Innovative Medical Devices: speed up overseas innovative medical devices entry into Chinese market

Chinese Special Examination and Approval Procedures for Innovative Medical Devices: speed up overseas innovative medical devices entry into Chinese market

Chinese regulatory authorities ---- China Food and Drug Administration unprecedentedly set a special examination and approval procedures for innovative medical devices since March 1, 2014, which provides a opportunity to speed up overseas innovative medical devices entry into Chinese market, and reduce risk from the registration examination uncertainty and approval delays to eat up your time and energy. Chinese Special Examination and Approval Procedures for Innovative Medical Devices: speed up overseas innovative medical devices entry into Chinese market provided a comprehensive and thorough knowledge of the latest Chinese special examination and approval procedures for innovative medical devices to guide your practical operation how to comply with the Chinese regulations.

China’s regulatory framework for medical devices is undergoing radical changes. 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 as well as an ageing population, 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. On the Chinese medical device market, imported overseas 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 by 2015, and will surpass Japan to become the second largest medical device market behind the United States.

The Chinese medical device market is attracting more and more overseas medical device manufacturers and producers to penetrate such market.

Chinese regulatory authorities ---- China Food and Drug Administration unprecedentedly set a special examination and approval procedures for innovative medical devices since March 1, 2014, which provides a opportunity to speed up overseas innovative medical devices entry into Chinese market, and reduce risk from the registration examination uncertainty and approval delays to eat up your time and energy. Chinese Special Examination and Approval Procedures for Innovative Medical Devices: speed up overseas innovative medical devices entry into Chinese market provided a comprehensive and thorough knowledge of the latest Chinese special examination and approval procedures for innovative medical devices to guide your practical operation how to comply with the Chinese regulations.

The organizations of this guidebook are arranged as follows. Chapter 2 introduces what innovative medical devices are applicable to Chinese special examination and approval procedures. Chapter 3 introduces who are the Chinese regulatory authorities for special examination and approval of overseas innovative medical devices. Chapter 4 elaborates the special regulations for overseas applicant. Chapter 5 introduces how many application dossiers for an oversea innovative medical device should be prepared. Chapter 6 provides the practical guidance for application of special examination and approval of overseas innovative medical devices. Chapter 7 elaborates the benefits from special examination and approval of innovative medical devices: process priority and interactive mechanism. Chapter 8 conclusion gives significant suggestions for overseas and multinational medical device manufacturers to acquire the qualifications of special examination and approval for overseas innovative medical devices.

The audiences of this guidebook are overseas medical device manufacturers wishing to enter into the Chinese medical device market, and multinational medical device companies have penetrated into the Chinese medical device market, and their senior executive officers engaging in regulatory affairs expecting to understand how to apply for registration of their medical device products in China, how to comply with the latest Chinese regulations for medical device registration.

After having skimmed through this guidebook, audiences can clearly acquire not only a comprehensive and thorough knowledge of the latest Chinese special examination and approval of overseas innovative medical devices but also the practical operation how to comply with the latest Chinese special examination and approval of overseas innovative medical devices. Access China Management Consulting Ltd hopes this guidebook, based on full and accurate regulations, can guide overseas and multinational medical device manufacturers and producers to achieve a successful entry into the Chinese medical device market, and smoothly operate their products in China.

Chinese Special Examination and Approval Procedures for Innovative Medical Devices: speed up overseas innovative medical devices entry into Chinese market provided a comprehensive and thorough knowledge of the latest Chinese special examination and approval procedures for innovative medical devices to guide overseas and multinational medical device manufacturers how to conduct practical operation in compliance with the Chinese regulations.

Chinese regulatory authorities ---- China Food and Drug Administration unprecedentedly set a special examination and approval procedures for innovative medical devices since March 1, 2014, which provides a opportunity to speed up overseas innovative medical devices entry into Chinese market, and reduce risk from the registration examination uncertainty and approval delays to eat up your time and energy. How to grasp the opportunity to speed up your innovative medical device product approval time? The overseas and multinational medical device manufacturers must have a comprehensive and thorough knowledge of the Chinese special examination and approval procedures for innovative medical devices.

Chinese Special Examination and Approval Procedures for Innovative Medical Devices: speed up overseas innovative medical devices entry into Chinese market provided a comprehensive and thorough knowledge of the latest Chinese special examination and approval procedures for innovative medical devices to guide overseas and multinational medical device manufacturers how to conduct practical operation in compliance with the Chinese regulations.

Report Highlights

What innovative medical devices are applicable to Chinese special examination and approval procedures.
Who are the Chinese regulatory authorities for special examination and approval of overseas innovative medical devices?
The Chinese special regulations for overseas applicant.
How many application dossiers for an oversea innovative medical device should be prepared.
The detailed practical guidance for application of special examination and approval of overseas innovative medical devices to smoothly navigate complex regulatory requirements step by step.
What are the benefits from Special Examination and Approval of Innovative Medical Devices: Process Priority and Interactive Mechanism?
The significant suggestions for overseas and multinational medical device manufacturers to acquire the qualifications of special examination and approval for overseas innovative medical devices.


Chapter 1 Executive Summary
Chapter 2 What Innovative Medical Devices are Applicable to Chinese Special Examination and Approval Procedures
Chapter 3 Who are Chinese Regulatory Authorities for Special Examination and Approval of Overseas Innovative Medical Devices
Chapter 4 Special Regulations for Overseas Applicant
Chapter 5 How Many Application Dossiers for Oversea Innovative Medical Device should be Prepared
Table 1. Application Form for Special Examination and Approval of Innovative Medical Device
Chapter 6 Practical Guidance for Application of Special Examination and Approval of Overseas Innovative Medical Devices
Table 2. Notification Letter of Review on Application for Special Examination and Approval of Innovative Medical Device
Figure 1. Application Steps for Special Examination and Approval Procedures of Innovative Medical Device
Chapter 7 What are the benefits from Special Examination and Approval of Innovative Medical Devices: Process Priority and Interactive Mechanism
Table 3 Application Form for Information Communication and Exchange of Innovative Medical Device
Table 4. Feedback Letter for Application of Information Communication and Exchange of Innovative Medical Device
Figure 2. Overview of the Benefits for Processing of the Registration of an Innovative Medical Device
Chapter 8 Conclusion
Table 1. Application Form for Special Examination and Approval of Innovative Medical Device.
Table 2. Notification Letter of Review on Application for Special Examination and Approval of Innovative Medical Device.
Table 3 Application Form for Information Communication and Exchange of Innovative Medical Device
Table 4. Feedback Letter for Application of Information Communication and Exchange of Innovative Medical Device
Figure 1. Application Steps for Special Examination and Approval Procedures of Innovative Medical Device.
Figure 2. Overview of the Benefits for Processing of the Registration of an Innovative Medical Device

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