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  4. > 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.

Summary

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.

Table Of Contents

Chinese Special Examination and Approval Procedures for Innovative Medical Devices: speed up overseas innovative medical devices entry into Chinese market
Contents.1
Chapter 1 Executive Summary. 3
Chapter 2 What Innovative Medical Devices are Applicable to Chinese Special Examination and Approval Procedures.5
Chapter 3 Who are Chinese Regulatory Authorities for Special Examination and Approval of Overseas Innovative Medical Devices.7
Chapter 4 Special Regulations for Overseas Applicant.7
Chapter 5 How Many Application Dossiers for Oversea Innovative Medical Device should be Prepared.8
Table 1. Application Form for Special Examination and Approval of Innovative Medical Device.9
Chapter 6 Practical Guidance for Application of Special Examination and Approval of Overseas Innovative Medical Devices.13
Table 2. Notification Letter of Review on Application for Special Examination and Approval of Innovative Medical Device.15
Figure 1. Application Steps for Special Examination and Approval Procedures of Innovative Medical Device.17
Chapter 7 What are the benefits from Special Examination and Approval of Innovative Medical Devices: Process Priority and Interactive Mechanism.19
Table 3 Application Form for Information Communication and Exchange of Innovative Medical Device.21
Table 4. Feedback Letter for Application of Information Communication and Exchange of Innovative Medical Device.24
Figure 2. Overview of the Benefits for Processing of the Registration of an Innovative Medical Device.27
Chapter 8 Conclusion.29

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