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Published Date: January 28, 2015
Page Count: 32
Unit Price: US$ 750
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Format: Electronic PDF copy


Chinese Special Examination and Approval Procedures for Innovative Medical Devices
speed up overseas innovative medical devices entry into Chinese market
Summary Table of contents

Executive Summary

 

Now, 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.

 

However, In China, the process of application and approval for imported overseas medical device registration is very complex, because the Chinese medical device authorities administer and control this process by exorbitant administrative regulations and measures. Moreover, these exorbitant administrative measures and regulations are variable and lack of transparency. In addition, the cultural difference between China and Western countries as well as the language barriers will increase the challenge faced by overseas and multinational medical device manufacturers and producers.

 

Nonetheless along with radical changes of regulatory framework for medical devices, Chinese regulatory authorities ---- China Food and Drug Administration (hereafter called as CFDA) set a special examination and approval procedures for innovative medical devices since March 1, 2014 to encourage research and innovation of medical devices, promote the popularization and application of new technologies for medical devices, and promote the development of the medical device industry.

 

Chinese special examination and approval procedures for innovative medical devices established a fast-track approval path and an interactive mechanism between Chinese regulatory authorities and applicant for innovative medical devices, which reduce risk from the examination uncertainty and approval delays to eat up your time and energy so as to achieve a successful entry into such a lucrative medical device market, and to avoid trouble for your business smoothly in China.

 

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 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.

 

Report Highlights

 

l         What innovative medical devices are applicable to Chinese special examination and approval procedures.

l         Who are the Chinese regulatory authorities for special examination and approval of overseas innovative medical devices?

l        The Chinese special regulations for overseas applicant.

l        How many application dossiers for an oversea innovative medical device should be prepared.

l        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.

l        What are the benefits from Special Examination and Approval of Innovative Medical Devices: Process Priority and Interactive Mechanism?

l        The significant suggestions for overseas and multinational medical device manufacturers to acquire the qualifications of special examination and approval for overseas innovative medical devices.

 

Who should buy this report?

  • Overseas medical device manufacturers wishing to enter into the Chinese in-vitro diagnostic reagent market.
  • Multinational medical device manufacturers have penetrated into the Chinese medical device market.
  • Companies interested in understanding the latest Chinese laws and regulations for imported medical device registration.
  • Senior executive officers engaging in regulatory affairs for exporting overseas medical device into Chinese lucrative medical device market.
  • Senior executive officers engaging in applying for approval of exporting overseas medical device registration in China.
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